Q1 2024 OptiNose Inc Earnings Call
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Operator: Good day, and thank you for standing by. Welcome to OptiNose Q1 2024. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone, and you will then hear an automated message advising your hand. For all your questions, please press star 1 1. Please be advised that today's conference is being, So now I'd like to hand the conference over to your speaker today, Jonathan Neely, VP of Investment Relations. Please go ahead.
Good day, and thank you for standing by.
Welcome to the afternoon Q1, 2024 earnings conference call.
Speaker Change: This time, all participants are in a listen only mode.
Speaker Change: After the speaker's presentation, there will be a question and answer session.
Speaker Change: To ask a question during the session you will need to press star one on your telephone.
Speaker Change: You will then hear an automated message advising your hand is raised.
Speaker Change: To withdraw your question. Please press star one again.
Please be advised that today's conference is being recorded.
Speaker Change: I'd now like to hand, the conference over to your Speaker today, Jonathan Neeley VP of Investor Relations. Please go ahead.
Jonathan Neely: Good morning, and thank you for joining us today as we review OptiNose's first quarter 2024 performance and our plans for the year ahead. I'm joined today by our CEO, Dr. Ramy Mahmoud. These slides that will be presented on this call can be viewed on our website, OptiNose.com, in the Investor 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.
Jonathan Neely: Good morning, and thank you for joining us today as we review after knows its first quarter 2024 performance and our plans for the year ahead.
Speaker Change: I'm joined today by our CEO, Dr. Rami My bad.
Jonathan Neely: Slides that will be presented on this call can be viewed on our website at <unk> dot 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.
Jonathan Neely: 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. Please exercise caution not to place 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. I 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. Thank you, Jonathan.
Jonathan Neely: <unk> additional information regarding these factors and forward looking statements are 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 and Optimizes. 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 <unk> dot.
Jonathan Neely: Com.
Jonathan Neely: You are cautioned not to place undue reliance on forward looking statements forward looking statements. During this conference call speak only as of the original date of this call or any earlier date indicated in such statement and we undertake no obligation to update or revise any of these statements.
Jonathan Neely: 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.
Ramy A. Mahmoud: And thank you to everyone listening for joining us this morning. We appreciate you joining us for our first quarter 2024. Starting on slide three, I'll start with a brief outline of what we'll cover during our call today. To start off, I'll review three key takeaways from today's call and discuss our initial plans to reach out to our ENT and allergy specialist physician audience with EXANSE'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.
Rami: Thank you Jonathan and thank you to everyone listening for joining us. This morning. We appreciate you joining us for our first quarter 2024 update.
Rami: Starting on slide three.
Rami: I'll start with a brief outline of what we'll cover during our call today to start off I'll review three key takeaways from today's call and discuss our initial plans to reach out to our Emt and allergy specialist physician audience with extensive new clinical profile, including communication of data showing strong efficacy in chronic sinusitis, which our market research.
Rami: Indicators, a leading driver of prescribing behavior next.
Ramy A. Mahmoud: Next, Jonathan Neely, our VP of Investor Relations and Business Development, will review our first quarter 2024 performance and our financial guidance for full year 2024. Finally, I'll return to review information about our peak net revenue estimates for XHANSE and the profitability targets that we described on our XHANSE chronic sinusitis launch call in April. Then we'll wrap up the call and take your questions. Turning to slide four.
Rami: Next to Jonathan Neeley, our VP of Investor Relations and business development will review, our first quarter 2024 performance and our financial guidance for full year 2024.
Jonathan Neely: Finally, I will return to review information about our peak net revenue estimates for exams and the profitability targets that we described on Rx hands chronic sinusitis launch call in April and we'll wrap up the call and take your questions.
Speaker Change: Turning to slide four.
Ramy A. Mahmoud: We'll go into more detail in a moment, but I'd like to highlight three 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 the potential to reshape this business in the last three quarters of 2024 and for years into the future. Claims data suggest that chronic sinusitis is currently being diagnosed by health care providers at least 10 times more frequently than nasal polyps.
Jonathan Neely: I'll go into more detail in a moment, but I'd like to highlight three key takeaways from today's presentation.
Speaker Change: 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.
Jonathan Neely: Claims data suggest the chronic sinusitis is currently being diagnosed by health care providers at least 10 times more frequently than nasal polyps.
Ramy A. Mahmoud: Following our national launch meeting the week of April 8th, 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 Salesforce 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 million in producing positive income from operations for full year 2025. Second, thanks to the efforts of our team, we have a significantly stronger base to build on than we did at the start of 2023.
Jonathan Neely: Following our national launch meeting to meet the April eight we have now fully engaged our sales team and our chronic sinusitis launch with training and a full set of materials.
Jonathan Neely: 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 obtaining peak year sales of at least $300 million.
Jonathan Neely: Producing positive income from operations for full year 2025.
Jonathan Neely: Second thanks to the efforts of our team we have a significantly stronger base to build on and then we did at the start of 2023.
Ramy A. Mahmoud: When I started as CEO, we implemented an initiative to greatly increase our operating efficiency and to stabilize expansion revenue while preparing our organization to seize the greatly expanded opportunity in chronic sinusitis. We successfully met or exceeded the financial expectations we set for the last five consecutive quarters of revenue achievement, aggressive operating expense reductions, and improvements in our average net revenue per prescription. Third, 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.
CEO: When I started as CEO, we implemented an initiative to greatly increase our operating efficiency and to stabilize <unk> revenue, while preparing our organization to seize the greatly expanded opportunity in chronic sinusitis.
CEO: We successfully met or exceeded our financial expectations, we set for the last five consecutive quarters of revenue achievement aggressive operating expense reductions and improvements in our average net revenue per prescription.
Speaker Change: Third the combination of expanded market opportunity and improved base business fundamentals has set up the opportunity for <unk> to return to strong growth in 2024.
Ramy A. Mahmoud: 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 Exhance Net Revenues to increase by 20% to 34% for full year 2024 compared to full year 2023. We also believe that enhanced net revenue growth can be achieved with modest incremental operating expense increases to support promotional efforts while leveraging our existing commercial infrastructure. Turning to slide five.
Speaker Change: We've now announced our initial guidance for full year 2024, net revenues and total operating expenses.
Speaker Change: Mindful that the full launch of the <unk> indication started in mid April we expect <unk> net revenues to increase by 20% to 34% for full year 2024 compared to full year 2023.
Speaker Change: We also believe that <unk> net revenue growth can be achieved with modest incremental operating expense increases to support promotional efforts, while leveraging our existing commercial infrastructure.
Speaker Change: Turning to slide five.
Ramy A. Mahmoud: Last week, we announced a $55 million registered direct financing, which was led by Nanta Hela and D.E. Shaw and had participation from both new and existing healthcare-focused investors. As a result of this funding, OptiNose now has cash and cash equivalents of approximately $100 million. Following on the recent approval of the chronic sinusitis indication, this funding 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 Change: Last week, we announced a $55 million registered direct financing, which was led by NAND to Haleigh M. D E Shaw and had participation from both new and existing health care focused investors.
Speaker Change: As a result of this funding Opdivo is now as cash and cash equivalents of approximately $100 million.
Speaker Change: 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.
Ramy A. Mahmoud: As 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 31st 2025 financial statements, which is expected to occur in March of 2026. Additionally, the minimum liquidity covenant will be reduced from $30 million to $20 million following the date of the first quarterly payment principal, which is due on September 30, 2025. We also extinguished $4.7 million of outstanding amendment and waiver fees, which have now been converted to equity.
unknown: As 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.
Speaker Change: Additionally, the minimum liquidity covenant will be reduced from 30 million to $20 million. Following the date of the first quarterly payment of principal which is due on September 32025.
Speaker Change: We also extinguished $4 $7 million of outstanding Amendment, and waiver fees, which have now been converted to equity.
Ramy A. Mahmoud: 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 enhanced launch plan. Turning to slide 7 in our launch plan. In the second quarter of this year, we are leveraging four major tactics to launch Exhans into this major new market opportunity. These include our sales force, non-personal promotion, peer-to-peer education, and presence at medical meetings.
Speaker Change: As a result of this financing in our revised debt agreement after notices and greatly strengthened financial position to consider multiple future opportunities for value creation with our initial focus remaining squarely on our <unk> launch plan.
unknown: Turning to slide seven and our launch plan.
unknown: In the second quarter of this year, we are leveraging four major tactics to launch <unk> into this major new market opportunity.
unknown: These include our Salesforce non personal promotion peer to peer education and presence at medical meetings.
Ramy A. Mahmoud: Let's begin with our 75-person sales organization. In the second quarter, our team plans to reach approximately 7,500 target health care providers and make over 35,000 total sales calls. We're also supplying the field with 50% more XAN samples to stimulate additional physician and patient trials. In a highly symptomatic condition like chronic sinusitis, samples can be effective in facilitating new product adoption.
unknown: To begin with our 75 person sales organization in.
Speaker Change: In the second quarter, our team plans to reach approximately 7500 target health care providers and make over 35000 total sales calls.
Speaker Change: We're also supplying to field with 50% more <unk> samples to stimulate additional physician and patient trial.
Speaker Change: In a highly symptomatic condition my chronic sinusitis samples can be effective in facilitating new product adoption.
Ramy A. Mahmoud: It's still very early days for us in the field, but initial feedback has been quite positive, execution has been strong, and we expect the momentum in ExhansPrescribing to build over time with continued Salesforce 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.
Speaker Change: It's still very early days for us in the field, but initial feedback has been quite positive execution has been strong and we expect the momentum in <unk> prescribing to build over time with continued sales force engagement.
Speaker Change: We are supplementing the field force with non personal promotion targeting a total of 22000 of the highest potential largely specialty prescribers.
Speaker Change: These tactics include digital media search engine marketing and social media.
Ramy A. Mahmoud: In the second quarter, we plan to generate 1.5 million health care provider impressions and over 50,000 customer engagements using this approach. We'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 second quarter, we plan to reach over 1,000 healthcare providers to highlight the new Exant clinical profile and discuss unmet needs and diagnostic criteria, which are important considerations for facilitating appropriate patient identification in the clinic.
unknown: In the second quarter, we plan to generate $1 5 million health care provider impressions and over 50000 customer engagements using this approach.
Speaker Change: We'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.
Speaker Change: The second quarter, we plan to reach over 1000 health care providers to highlight the new <unk> clinical profile and discuss unmet need and diagnostic criteria, which are important considerations for facilitating appropriate patient identification in the clinic.
Ramy A. Mahmoud: Lastly, we're planning a strong presence at medical meetings during the second quarter, 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 XANCE, and reinforcing our leadership and visibility in the chronic sinusitis space. Taken together, these four tactical pillars are essential elements of our launch plan.
Speaker Change: Lastly, we're planning a strong presence at medical meetings during the second quarter, including 10 National and <unk> regional event for Emts and allergists.
Speaker Change: We have a boost where our team can interface with prescribers and are also planning to host promotional events such as product theaters with speakers.
Speaker Change: These events are aimed at disseminating our message about the recent approval and new clinical trial data reinforcing the clinical benefits of <unk> hands, and reinforcing our leadership and visibility in the chronic sinusitis space.
Speaker Change: Taken together these four tactical pillars are essential elements of our launch plan.
Ramy A. Mahmoud: 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 an overall improvement in the rate of written prescriptions that are ultimately filled, and the rate at which insurance coverage and copay support are correctly applied to each prescription. Our generous co-pay support group program will continue to facilitate patient starts, with many patients being offered $0 co-pays in their first month.
Speaker Change: 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 an insurance coverage and co pay support our correctly applied to each prescription.
Speaker Change: Our generous co pay support program, we will continue to facilitate patient starts with many patients being offered as zero dollar co pays in their first month.
Ramy A. Mahmoud: Although many of these new initiations are not captured by IQVIA, they can help patients and providers gain personal experience with the benefits of Xhans, even if insurance coverage is still pending. We're also aware that it can often require five to seven calls to new physicians before the initiation of product trials, and that successful product trials are a precursor to consistent adoption over time. We believe our planned efforts will get the ball rolling and result in gradually accelerating product uptake.
Speaker Change: Although many of these new initiations are not captured by <unk> that can help patients and providers gain personal experience with the benefits of <unk>, even if insurance coverage is still pending.
Speaker Change: We're also aware that it can often require five to seven calls on new physicians before initiation of product trials and that successful product trials are a precursor for consistent adoption over time.
Speaker Change: We believe our planned efforts, we will get the ball rolling and resulting gradually accelerating product uptake.
Ramy A. Mahmoud: 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 first few months following approval, are expected to drive an uptick in enhanced growth this year and ultimately deliver at least $300 million in peak sales in the peak year. I would now like 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 9th. Jonathan
Speaker Change: All of 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 first few months. Following approval are expected to drive an uptick in <unk> growth this year and ultimately deliver at least $300 million in peak sales.
Speaker Change: In peak year.
Speaker Change: 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 9th Jonathan.
Jonathan Neely: Thank you, Ramy. Turning to slide nine. We are encouraged by our first quarter 2024 financial results. Regarding revenue, OptiNose recognized $14.9 million of expansion net revenue in the first quarter of 2024, a 26% increase compared to first quarter 2023 net revenues of $11.8 million. As discussed on our last earnings call, strength and demand afforded us the opportunity to make gradual changes 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.
Jonathan Neely: Thank you Rami turning to slide nine we are encouraged by our first quarter 2024 financial results.
Jonathan Neely: Regarding revenue Optimists recognized $14 9 million of expense that revenue in the first quarter of 2024, 26% increase compared to first quarter 2023, net revenues of $11 $8 million.
Jonathan Neely: As discussed on our last earnings call strengthened demand afforded us the opportunity to make gradual changes that we had that have had a positive influence on profitability in late 2023 in early 2024, we made gradual revisions to our co pay assistance program and implemented new hub services.
Jonathan Neely: These changes have prioritized growth in profitable prescriptions and have reduced both the number and proportion of unprofitable prescriptions. The net result is evident in the enhanced 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 enhanced average net revenue per prescription for the first quarter of 2024 was $227 per prescription.
Speaker Change: These changes have prioritize growth and profitable prescriptions and have reduced both the number and proportion of unprofitable prescriptions.
Speaker Change: The net result is evident in <unk> net revenue per prescription.
Speaker Change: 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 <unk> average net revenue per prescription for the first quarter of 2024 was $227 per prescription.
Jonathan Neely: This is a 63% increase compared to $139 of estimated average net revenue per prescription in the first quarter of 2023. In addition to the changes in copay assistance and the implementation of hub services, we believe the disruption in services that changed the healthcare claims processor for our vendor that administers the enhanced copay support program hindered access to our copay benefit for uncovered patients. We believe this disruption had a favorable effect on enhanced net revenue per prescription and expect it to be isolated to first quarter 2024. Finally, as we reported earlier, OptiNose recognized $21.7 million of SG&A plus R&D expenses in the first quarter of 2024.
Speaker Change: 63% increase compared to $139 of estimated average net revenue per prescription in the first quarter of 2023. In addition to the changes in co pay assistance and the implementation of hub services. We believe the disruption in services of change healthcare claims processor for our vendor that administers the <unk> co pay support program hindered.
Speaker Change: Access to our co pay benefit.
Speaker Change: For uncovered patients. We believe this disruption had a favorable effect on SaaS net revenue per prescription and expect it to be isolated to first quarter 2024.
Speaker Change: Finally, as we reported earlier <unk> recognized $21 $7 million of SG&A, plus R&D expenses in the first quarter 2024, there is approximately a $3 million or a 11% decrease compared to first quarter 2023 expenses of $24 5 million.
Jonathan Neely: This is approximately a $3 million, or 11%, decrease compared to first quarter 2023 expenses of $24.5 million. Last week, we announced our initial financial guidance for full year 2024 enhanced net revenue and full year 2024 operating expenses. In addition, given the stronger than expected performance in the first quarter of 2024, we increased our expectation for full year 2024 expanse net revenue per prescription. First, for the full year of 2024, we expect total operating expenses to be between $95 to $101 million, of which approximately $6 million is expected to be stock-based compensation.
Speaker Change: Last week, we announced our initial financial guidance for full year 2024, ex handset revenue and full year 2020 for operating expenses. In addition, given the stronger than expected performance in the first quarter 2024, we increased our expectation for full year 2024 exams net revenue per prescription.
Speaker Change: First for the full year of 2024, we expect total operating expenses to be between $95 million to $101 million of which approximately $6 million is expected to be stock based compensation.
Jonathan Neely: Second, we anticipate strong growth for ExpanseNet revenues given the expanded market opportunity available in CS. Our expectation for ExpanseNet revenue for full year 2024 is between $85 million and $95 million. Finally, we now expect Expanse Net Revenues per prescription to exceed $230 for the full year of 2024. Previously, we expected Expanse Net Revenues per prescription to be approximately $220 for the full year of 2024. I'm going to turn the call back over to Ramy for his closing remarks. Thank you, Jonathan. Turning to slide 13.
Speaker Change: Second we anticipate strong growth for <unk> SaaS net revenues given the expanded market opportunity available in CFS, our expectation for <unk> net revenue for full year 2024 is between $85 million to $95 million.
Speaker Change: Finally, we now expect <unk> net revenues per prescription to exceed $230 for the full year of 2024 previously we expected to access net revenues per prescription to be approximately $220 for the full year of 2024.
Speaker Change: Turning the call back over to Rami for closing remarks Rami. Thank.
Speaker Change: Thank you Jonathan turning to slide 13.
Ramy A. Mahmoud: In April, we provided a financial outlook for expansion 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 investment 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.
Rami: In April we provided our financial outlook for <unk> and chronic sinusitis that we believe we can meet or exceed within our base business.
Rami: 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 investment 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 future expansion of our sales organization.
Ramy A. Mahmoud: We may consider future expansion of our sales organization to further accelerate our launch. Although 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 exams for a significantly larger population of approximately 3 million 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 the office, a procedure which is often relied on to confirm a diagnosis of nasal polyps.
Rami: To further accelerate our launch.
Speaker Change: Although 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 <unk> for a significantly larger population of approximately 3 million patients cared for in our specialty segment.
Speaker Change: Importantly, we believe that a much broader range of physicians, commonly make the diagnosis of chronic sinusitis in the diagnosis of nasal polyps. This includes prescribers who are not equipped to routinely performed nasal endoscopy in office procedure, which is often relied on to confirm a diagnosis of nasal polyps.
Ramy A. Mahmoud: With this in mind, we believe we can realistically achieve peak net revenues of at least $300 million and produce positive income from operations for the full year 2025. Turning to slide 14. In 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 million, and we will carefully consider if and when this incremental investment is appropriate.
Speaker Change: With this in mind, we believe we can realistically achieve peak net revenues of at least $300 million and produce positive income from operations for full year 2025.
Turning to slide 14.
Speaker Change: In addition to the potential within our base business. We believe there is 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.
Speaker Change: 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.
Speaker Change: 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 million.
Speaker Change: And we will carefully consider if and when this incremental investment is appropriate.
Ramy A. Mahmoud: 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 million actively diagnosed and treated patients with chronic sinusitis. In the future, we could also invest in capital efficient approaches to activating the 20 million additional patients with chronic sinusitis who are symptomatic but are not actively seeking care each year.
Speaker Change: Next we believe our product is well suited to support outreach to our 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 million actively diagnosed and treated patients with chronic sinusitis.
Speaker Change: In future, we could also invest in capital efficient approaches to activating the 20 million additional patients with chronic sinusitis, who are symptomatic, but not actively seeking care each year.
Ramy A. Mahmoud: Based on the direct-to-consumer pilot data that we have, we believe the enhanced product profile is well-suited to support strong patient activation. Third, I'd like to note that, to date, we have not invested significant energy in establishing international partnerships for Exant, but we have maintained patents in select major markets. Lastly, we aim to leverage our existing infrastructure, particularly our commercial infrastructure, to generate synergies by working on additional products. OptiNose is establishing strong infrastructure, experience, and competencies in what we consider the comparatively blue ocean ENT and allergy specialty space.
Speaker Change: Based on direct to consumer pilot data that we have we believe the <unk> product profile is well suited to support strong patient activation.
Speaker Change: Third I'd like to note that to date, we have not invested significant energy in establishing international partnerships for <unk>, but we have maintained patents in select major markets.
Speaker Change: These represent another potential incremental source of value.
Speaker Change: Lastly, we aim to leverage our existing infrastructure, particularly our commercial infrastructure to generate synergies by working on additional products.
Speaker Change: <unk> is establishing strong infrastructure experience and competencies in what we consider the comparatively blue Ocean Emt and allergy specialty space.
Ramy A. Mahmoud: As we generate income from operations, which we expect for full year 25, and continue to strengthen the organization, OptiNose has the 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 needs in our specialty areas. Turning to slide 15.
Speaker Change: As we generate income from operations, which we expect for full year 'twenty five and continue to strengthen the organization.
unknown: <unk> has potential to become the commercialization or development partner of choice for companies in the specialty space.
Speaker Change: 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 roots and build a pipeline of new and innovative treatments to address unmet need in our specialty arena.
Speaker Change: Turning to slide 15.
Ramy A. Mahmoud: Before moving to take any questions, I'd like to reiterate the significance of the opportunity in front of us, which we believe has the potential to reshape our business starting in the second quarter of this year and for years into the future. We are pleased with our success in executing our pre-launch operating strategy through 2023 in the first quarter 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 Exhans as the first prescription treatment for one of the most common diseases diagnosed in adult outpatient medicine.
Speaker Change: 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 second quarter of this year and for years into the future.
Speaker Change: We're pleased with our success in executing our prelaunch operating strategy through 2023 in the first quarter of 2024, we.
Speaker Change: 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 <unk> as the first prescription treatment for one of the most common diseases diagnosed in adult outpatient medicine.
Operator: We believe the launch opportunity we are just getting off the ground, coupled with our recent financing, positions us well to build a profitable ENT analogy-focused business by accessing greatly expanded net revenue potential through an efficient existing base of commercial capability. 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 sector.
Speaker Change: We believe the launch opportunity we are just getting off the ground coupled with our recent financing position us well to build a profitable emt and allergy focused business by accessing greatly expanded net revenue potential through an efficient existing base of commercial capabilities.
Speaker Change: In addition, we believe the chronic sinusitis indication will facilitate commercial partnerships or other approaches to accessing incremental value in the primary care space.
Speaker Change: In addition to what we can access on our own and the specialty segments.
Operator: With that, I'd like to thank you for your attention and open up the call for Q&A. As a reminder, call 1-1 on your telephone and wait for your name for all your questions. Start 1-1, by while we compile.
Speaker Change: With that I'd like to thank you for your attention and open up the call for Q&A.
Speaker Change: As a reminder to ask a question. Please press star one one on your telephone.
Speaker Change: For your name to be announced to withdraw your question. Please press star one again.
Please standby, while we compile the Q&A roster.
Thomas Flaten: And our first question. Thomas Flaten with Lake Street Capital, www.optiNose.com, Good 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 queue about the change healthcare 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 be over the course of the year. We're used to seeing a huge swing upward in the second quarter, but I'm not sure if we should be thinking the same way for this year. Any help there would be great.
Speaker Change: And our first question comes from Thomas Flaten with Lake Street Capital Markets. Your line is now open.
Unknown Executive: If you want to pick up the parts about Change Harris Care, and I'll talk about the case. Well, so we do believe changing 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 first quarter of 2024 than we did in prior years. So we do think there's still a seasonal trend, if you will, where the first quarter will generally be lower than subsequent quarters.
Thomas Flaten: Good morning, I appreciate you guys taking the questions.
Thomas Flaten: I'm just trying to digest the significant upside to the average revenue per prescription, particularly in light of the comments made in the Q about the change healthcare potentially one time upside.
I was just curious if you could help us maybe map out how you expect.
Thomas Flaten: The average revenue per prescription to what the cadence is going to be over the course of the year, we're used to seeing huge swing upward in the second quarter, but I'm not sure. If we should be thinking the same way for this year any help there would be greatly appreciate it.
change healthcare: I'll pick up the parts about change healthcare and I'll talk about the cadence.
Thomas Flaten: We do believe change health or health care had an effect, but as we pointed out in our comments Tom.
Thomas Flaten: It's not the only reason that we had a higher average net revenue per prescription in the first quarter of 2024.
Speaker Change: Then we did in prior years so we.
Speaker Change: We do think there is still a.
Tom: A seasonal trend if you will where first quarter will generally be lower than subsequent than subsequent quarters. However, what we've done is we've 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 and so in terms of thinking about the cadence within the year relative to <unk>.
Unknown Executive: However, what we've done is we've 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. 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.
Speaker Change: <unk> prior I don't think what we're projecting is.
Speaker Change: Really significant.
Speaker Change: The increase in revenue per prescription moving from Q1 into the rest of the year, but we do believe that.
Speaker Change: The changes that we put into the business proactively we're going to have a positive influence on revenue per prescription on a year over year basis, as we move through the year.
Unknown Executive: But we do believe that the changes that we put into the business proactively are 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 $220 to at least or exceed $230 per prescription. So we still do think that there's going to be improvement within the year. And then another thing I saw in the queue was that there was a comment that the number of covered lives that have access to ex-hans decreased from 80% to 70%.
Speaker Change: We've moved our estimate now up from approximately $220 to at least or to exceed $230 per prescription. So a student is still do think that theres going to be improvement within the year.
Speaker Change: And then another thing I saw in the Q was that there was a comment that you are the number of covered lives that have access to X. Hence decreased from 80% to 70% I was curious you can comment on that.
Unknown Executive: I was curious if you could comment on that. Yeah, 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.
Speaker Change: Yes, I think thats more a consequence of the way in which we are measuring it.
Speaker Change: Then it is a consequence of any change in coverage so.
Speaker Change: I apologize if you took away the wrong impression there.
Unknown Executive: 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 a harder diagnosis to make and less often coded for.
Speaker Change: The intent has always been.
Speaker Change: The expectation that we had was always that our number of covered lives wouldn't change materially with the new indication, but we do expect.
Speaker Change: Is an improvement.
Speaker Change: 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 harder.
Speaker Change: <unk> to make and less often quoted for.
Unknown Executive: And now to also have a chronic sinusitis indication, which is much more broadly coded for in outpatient visits. I think, I think historically, when we've talked about, you know, the percentage of lives that are, you know, covered, or implants that cover expanse, I think we historically focused on commercial only, but I think we've moved to providing a measure that's for all insurance plans, whether it's commercial or government. It makes sense. And then there was one final quick one.
Speaker Change: And now to be able to also have a chronic sinusitis indication, which is much more broadly coded for in outpatient visits.
Speaker Change: I think historically when we attack, yes, I think historically when we've talked about.
Speaker Change: <unk> of lives that are covered.
Speaker Change: <unk> plans that cover <unk>.
Speaker Change: We've historically focused on.
Speaker Change: Commercial only but I think we've.
Speaker Change: Move to providing a measure that.
Speaker Change: All insurance plans, whether it's commercial or government.
Unknown Executive: 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 No, 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 Change: Makes sense and then one final quick one the samples that you are handing out is that a full 30 day dose or are there 30 days of doses available in that or is there a smaller quantity of drug in the samples.
Speaker Change: No.
Speaker Change: <unk> most of the samples that we are handing out or a specific sample put up which is not a full 30 days. It's just enough to get you started.
Speaker Change: And hopefully gives you time to be able to receive your prescription from whichever pharmacy, including mail order that you might be accessing.
Unknown Executive: Thomas Flaten, Schuyler Broek, OptiNose Inc., One moment for our next question. Our next question: David Amsellem with Piper Sandler, your line: Hi, this is Schuyler. I'm for David.
Ross: Understood. Thanks, Ross Thanks, so much.
Tom: Thank you Tom.
Tom: Thank you one moment for our next question.
David A. Amsellem: Our next question comes from David <unk> with Piper Sandler Your line is now open.
Schuyler van den Broek: Can you speak anecdotally about what you've been seeing on the payer landscape front since the expanded label? Have there been any roadblocks to getting coverage for patients for 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 market? So, Schuyler, thanks for your questions. I'll start with the second one.
Skyler: Hi, This is skyler on for David can you speak anecdotally to what you've been seeing on the payer landscape.
David A. Amsellem: Label have there been any roadblocks to getting coverage for patients with nasal polyps.
Schuyler van den Broek: And then for net revenue per Rx in the long term how do you think that is kind of all within the context the latter label.
Unknown Executive: 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 business actions, but not really a function of the indication for which the drug is prescribed. With regard to anecdotes about insurance coverage, all I can share with you is, in fact, just anecdotes.
David A. Amsellem: So Scott Thanks for your questions I'll start with the second one with regard to average net revenue per prescription.
Scott: I don't I don't think we view that as something that is.
Scott: A function of the label change.
Scott: It's been very sensitive to changes we've made in our co pay support program.
Scott: And sort of other sort of business actions, but not really a function of the indication for which the drug is prescribed with regard to anecdotes about insurance coverage.
Unknown Executive: 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 Change: All I can share with you is in fact, just anecdotes is premature for us to have sort of broad patterns established since our launch there just hasnt been enough elapsed time.
Speaker Change: And of course, there are thousands of different insurance plans out there I can't speak to all of them.
Unknown Executive: I can tell you we have gotten specific anecdotal reports of the new indication being added to prior authorization forms, exactly as we've discussed before, which we 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 to the current prior authorization criteria. Got it.
Speaker Change: I can tell you we have gotten specific anecdotal reports of the new indication being added in two prior authorization forms exactly as we've discussed before.
Speaker Change: We would expect to happen over a number of months following the approval.
Speaker Change: And I am 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.
Unknown Executive: That's helpful. And then, on the sales force, I think you mentioned potential expansions in the future. Can you talk about what factors would inform that?
Speaker Change: Got it that's helpful. And then one more on the sales force I think you mentioned potential expansions in the future can you talk about what factors would inform that.
Unknown Executive: Yeah, I think we're looking to see the results of our initial promotional activities. You know, 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 the 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 Change: Yes, I think.
Speaker Change: We're looking to see the results.
Speaker Change: Of our initial promotional activities.
Speaker Change: We're following it closely with fairly intense analytics.
Speaker Change: And as we get a better sense of the uplift that we're generating.
Speaker Change: And these are.
Speaker Change: The drivers that are producing the best ROI.
Speaker Change: Then we will use that information to inform that the magnitude and the timing of any changes we are making our promotional activities.
Speaker Change: Got it helpful. Thank you.
Speaker Change: Thank you.
Unknown Executive: Helpful. Thank you. As a reminder, to ask a question, dial Star 1-1 on your telephone. Again, that is Star 1-1 to ask.
Speaker Change: As a reminder to ask a question. Please press star one on your telephone again that is star one wanted to ask a question.
Glen Santangelo: Our next question comes from Glen Santangelo with Jefferies. Your line is now open. Oh, yeah. Thanks for taking my question. Hey, Ramy, I also wanted to follow up on this. Transcribed by https://otter.ai. I'm trying to, you know, I thought it was going to be a relatively quick process, given the payer's familiarity with the product. In context with that, with the full year fiscal 24 guidance, and maybe the decision to leave the commercial infrastructure as is. Time.
Speaker Change: Our next question comes from.
Speaker Change: Glenn Santander flow with Jefferies. Your line is now open.
Speaker Change: Yes. Thanks for taking my question, Hey, Rami I also wanted to follow up on in terms of what Youre seeing in terms of payer coverage.
Speaker Change: You said youre gradually seeing the new indications and then can you give us a sense for maybe how long that will take because im 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.
Speaker Change: The full year fiscal 2000 and for guidance.
Speaker Change: And maybe the decision to lead the commercial infrastructure as is at this point in time.
Ramy A. Mahmoud: I guess what we're all trying to figure out is sort of the cadence. You know, when those payer contracts can be amended and when we should start to expect some acceleration in revenue. Well, Glenn, thank you for the question. This might sound obvious, but we don't directly control the pace at which these changes are made in 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, you know, I have concrete examples of cases where changes have already been made. Other examples where it hasn't been made.
Guess: Guess, what we're all trying to figure out sort of the cadence of which.
Speaker Change: Those payer contracts can be amended and when we should start to expect some acceleration on the revenue side.
Glenn Santander: Well so so Glenn thank you for the question.
Speaker Change #103: This might sound obvious but.
Speaker Change #111: We don't directly control the pace at which these changes are made at various insurance plans and there are.
Glenn: There's a small number of major pbms and insurers, but there are thousands and thousands of insurance plans.
Speaker Change #104: And I have concrete examples of cases, where the changes have already been made.
Speaker Change #107: <unk> made other examples where it hasnt been made so we are estimating that it could take in some plans a few weeks and some plans some months for these changes ultimately to rollout and 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 can be fully aware of.
Ramy A. Mahmoud: So, you know, we are estimating that it could take, you know, in some plans, a few weeks, in some plans, some months for these changes, you know, ultimately, to roll out. And 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, you know, we've done everything we could to facilitate their ability to make those changes. But, you know, at the end of the day, it's not something we directly control.
Speaker Change #113: Of the new indication that was coming.
Speaker Change #114: And we've done everything we can to facilitate their ability to make those changes.
Speaker Change #105: But at.
Speaker Change #106: At the end of the day, it's not something we directly control.
Ramy A. Mahmoud: And, you know, we, you know, you asked sort of, "When can we start seeing a difference in revenue?" We've tried to give you guidance that I think makes it clear that we're expecting, you know, an increase in revenue this quarter. So in the second quarter, we're expecting revenue to start increasing. And we expect it to increase, you know, over the remainder of the year, ultimately reaching $85 to $95 million for calendar 2024, which is meaningfully higher than 2023. 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.
Speaker Change #106: And.
Speaker Change #106: You asked sort of when can we start difference in revenue.
Speaker Change #115: We've tried to give you guidance that I think makes it clear that we're expecting.
Speaker Change: An increase in revenue this quarter. So in second quarter, we're expecting revenue to start increasing and we expect it to increase over the remainder of the year ultimately, reaching 85% to $95 million for calendar 2024, which is meaningfully higher than 2023, okay.
Ramy A. Mahmoud: 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 I don't think it's a contracting discussion. I think it's more having processes where the insurers reflect the state of the label of the product and have their business processes reflect that. It's not a renegotiation.
Speaker Change: Great.
Speaker Change: Glen.
Speaker Change: You did ask a question about that.
Glen: 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 largely contemplate the expanded label they contemplate rebates whenever the product is reimbursed.
Glen: Four FDA approved indications that are on the label.
Glen: Yes, I don't think.
Speaker Change: Contracting discussion I think it's more having processes at the insurers reflect the the state of the label the product in.
Speaker Change #116: Having having their business processes reflect that its not.
Speaker Change: Not a renegotiation.
Speaker Change #117: Maybe just two other quick ones from me and then I'll hop off.
Speaker Change #108: Total scripts and this quarter it looked like they were down a fair amount based on that average rent per script. I was wondering if you can sort of comment on that and then secondly on <unk>.
Speaker Change #119: 300 million peak sales number could you may be linear or.
John: John put a little bit more meat behind that number and how you sort of came to that number and how.
John: How we should think about that.
Speaker Change: Script and average revenue per script perspective. Thanks.
Unknown Executive: Transcribed by https://otter.ai, Script, and Average Web Perspective. So I mean, in terms of, you know, the prescriptions on a quarterly basis, you know, I think, you know, as we described, we've made some changes to our copay assistance program late in 2023 and again in early 2024 that, you know, we believe have, you know, kind of focused us on growing the profitable portion of our business and, you know, has reduced the number and proportion of unprofitable prescriptions.
Speaker Change: Sure. So I mean in terms of the prescriptions on a quarterly basis.
Speaker Change: I think.
Speaker Change: As we described.
Speaker Change #112: <unk> made some changes to our co pay assistance program.
Speaker Change #120: Late in 2023 and again in early 2024.
unknown: We believe is kind of focused us on growing the profitable portion of our business.
unknown: <unk> has reduced the number and proportion of unprofitable prescription so yes. The year over year result, if you look at prescriptions.
Unknown Executive: So, you know, the year-over-year result, you know, if you look at prescriptions, you're down, I think, almost 23% on a year-over-year basis. But importantly, you know, there are prescriptions leaving the business that, on net, improve our revenue performance by them no longer being filled. So, you know, 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 Change #122: Youre down I think almost 23% on a year over year basis, but importantly.
Speaker Change #123: There are prescriptions, leaving the business.
unknown: That.
Speaker Change #126: 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.
Unknown Executive: 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 of unprofitable or even negative revenue prescriptions. We also 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.
Speaker Change #127: And then just just to add a little bit to that you might have sort of missed it in the earlier comments, but.
Speaker Change #128: We are reducing the number of unprofitable or even negative revenue prescriptions. We also have.
Speaker Change #125: 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 represent the other thing I'll mention.
Speaker Change #118: I'm just sort of just as a reminder is that.
Speaker Change #118: The tracking of prescriptions by external third party providers.
Speaker Change #129: As imperfect and it's always been imperfect and it varies over time, how closely it mirrors, our actual numbers, but one of the things I highlighted in my earlier comments is that new initiations, which disproportionately we're trying to drive with the new plant.
Unknown Executive: And it's always been imperfect, and it varies over time how closely it mirrors our actual numbers. One of the things I highlighted in my earlier comments is that new initiations, which we're trying to drive with the new launch, new initiations that have a $0 copay may not be captured by third party data providers at all. So, they will be invisible to you.
Speaker Change #130: New initiations that have a zero dollar co pay may not be captured by third party data providers at all so it will be invisible to you.
Unknown Executive: I'll give you one last comment on the guide for the year and the implications for, you know, prescription growth and, you know, revenue per prescription growth. Yeah, I think, you know, given that we've provided a range for revenues and a floor, if you will, for revenue per prescription, I think if you reverse the math, you can derive that, you know, we're expecting both prescriptions to grow on a year-over-year basis. As well as, you know, revenues to grow on a year-over-year basis and along with, you know, the kind of revenue per prescription. All right, thank you very much, Glenn.
Speaker Change #130: So I'll give you one last I'll give you one last comment on the on the guide for the year and the implications for prescription growth and.
Speaker Change #130: Revenue per prescription growth.
Speaker Change #118: Yes.
Speaker Change #118: I think given that we've provided a range for revenues and a floor. If you will for revenue per prescription.
Speaker Change #131: Thank you reverse into the math.
Speaker Change #121: You can derive that we're expecting both prescriptions to grow on a year over year basis.
Speaker Change #121: As well as.
Speaker Change #121: Revenues to grow on a year over year basis.
Speaker Change #133: Along with kind of the revenue per prescription.
Speaker Change #133: Alright.
Speaker Change #124: You bet.
Unknown Executive: The last thing I'll add is you asked about the 300 million. My view is that the growth to get us from 2024 out to peak year is growth in the 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 nine months or so. But in the future, primarily, growth will come from increased uptake of the product. Thanks a lot.
Glenn: Well I'm sorry, Glenn the last thing I'll add is you asked about the $300 million.
Glenn: My view is that the.
Glenn: 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.
Glenn: There were a lot of levers to pull there sort of in the last let's say nine months or so.
Speaker Change #136: But in the future and primarily the growth will come from increased uptake of the product.
Speaker Change #124: Perfect. Thanks, a lot.
Unknown Executive: Thank you. One moment for our next question. Our next question comes from Matthew Caulfield. Hey, good morning, guys.
Speaker Change #124: Thank you one moment for our next question.
Speaker Change #124: Our next question comes from Matthew Coffield with HC Wainwright. Your line is now open.
Matthew Caulfield: Thanks for taking our question. And congrats on the successful launch. Appreciating the specialist-focused efforts targeted towards allergists and ENTs. Do you plan to share any granularity around, say, 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.
Matthew Coffield: Hey, good morning, guys. Thanks for taking our questions and congrats on the successful launch so far.
Matthew Coffield: So appreciate in the specialist focused efforts targeted towards allergists and E&ps 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 of any future sales efforts, presumably primary care could be prescribing.
Speaker Change #135: <unk>, just not being kind of the current focus.
Unknown Executive: Yeah, so, Matt, we, I mean, 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 universe, but it's not a huge number.
Matt: Yes, so Matt.
Matt: I mean, we haven't made a decision yet about sort of how we'll report out on the.
Matt: Indicators for future growth, but as you said our efforts right now are focused primarily on our specialty audience. We do have some primary care physicians in our called on universe that he was not a huge number.
Matt: And 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 in the sort of the manner in which the product is being used in the different segments of 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.
Unknown Executive: And 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 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. Okay, fair enough.
Matt: High prescribers specialty in the near future at least.
Unknown Executive: Very helpful and very excited to see the launch. Congratulations, guys. Thanks again, Matt.
Matt: Okay fair enough very helpful and very excited to see the launch congrats guys.
Matt: Thanks again, Matt.
Operator: Thanks. I'm showing no further questions at this time. I would now like to turn it back to Ramy Mahmoud, CEO, for closing. I'd like to thank you all for joining us this morning, appreciate your attention and help, and I hope you share our excitement about 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. We look forward to getting back with you again in August to share our second quarter results. This concludes today's conference. Thank you for participating.
Matt: Thank you.
Matt: Showing no further questions at this time I would now like to turn it back to Rami Mahmud CEO for closing remarks.
Ramy A. Mahmoud: Great 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 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 and we feel like we're in a much better position to really create shareholder value and to help them.
Ramy A. Mahmoud: <unk> 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 second quarter results.
Speaker Change #139: This concludes today's conference call.
Speaker Change #138: You for participating you may now disconnect.
Ramy A. Mahmoud: Thomas Flaten, Ramy Mahmoud, Unknown Executive, Jonathan Neely, Paul Spence, Thomas Flaten, Schuyler Broek, OptiNose Inc Thomas Flaten, Ramy Mahmoud, Unknown Executive, Jonathan Neely, Paul Spence, Thomas Flaten, Schuyler Broek, OptiNose Inc, Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Thomas Flaten, Ramy Mahmoud, Unknown Executive, Jonathan Neely, Paul Spence, Thomas Flaten, Schuyler Broek, OptiNose Inc, Ramy Mahmoud, Ramy Mahmoud, Unknown Executive, Jonathan Neely, Paul Spence, Thomas Flaten, Schuyler Broek, OptiNose Inc, Good day and thank you for standing by. Welcome to the OptiNose Q1 2024 Earnings Conference.
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Ramy A. Mahmoud: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand. To withdraw your question, please press star 1 1. Please be advised that today's conference is being, So now I'd like to hand the conference over to your speaker today, Jonathan Neely, VP of Investor Relations. Please go ahead.
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Speaker Change #138: Good day, and thank you for standing by.
Good morning, and thank you for joining us today as we review OptiNose's first quarter 2024 performance and our plans for the year ahead. I'm joined today by our CEO, Dr. Ramy Mahmoud. These slides that will be presented on this call can be viewed on our website, OptiNose.com, in the Investor 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.
Speaker Change #138: Welcome to the Aten is Q1 2024 earnings conference call.
Speaker Change #143: This time, all participants are in a listen only mode.
Speaker Change #142: After the speaker's presentation, there will be a question and answer session.
Speaker Change #144: To ask a question during the session you will need to press star one on your telephone.
Automated Message: You will then hear an automated message advising your hand is race.
Automated Message: To withdraw your question. Please press star one again.
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. Please exercise caution not to place und 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. I 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. Thank you, Jonathan.
Automated Message: Please be advised that today's conference is being recorded.
And thank you to everyone listening for joining us this morning. We appreciate you joining us for our first quarter 2024. Starting on slide three, I'll start with a brief outline of what we'll cover during our call today. To start off, I'll review three key takeaways from today's call and discuss our initial plans to reach out to our ENT and allergy specialist physician audience with EXANSE'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.
Automated Message: I'd now like to hand, the conference over to your Speaker today, Jonathan Neeley VP of Investor Relations. Please go ahead.
Next, Jonathan Neely, our VP of Investor Relations and Business Development, will review our first quarter 2024 performance and our financial guidance for full year 2024. Finally, I'll return to review information about our peak net revenue estimates for XHANSE and the profitability targets that we described on our XHANSE chronic sinusitis launch call in April. Then we'll wrap up the call and take your questions. Turning to slide four.
Jonathan Neely: Good morning, and thank you for joining us today as we review after knows as first quarter 2024 performance and our plans for the year ahead.
Speaker Change #141: I'm joined today by our CEO, Dr. Rami method.
Jonathan Neely: Slides that will be presented on this call can be viewed on our website at <unk> dot 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.
We'll go into more detail in a moment, but I'd like to highlight three 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 the potential to reshape this business in the last three quarters of 2024 and for years into the future. Claims data suggest that chronic sinusitis is currently being diagnosed by health care providers at least 10 times more frequently than nasal polyps.
Jonathan Neely: <unk> 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 and Optimizes. 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 <unk> dot.
Jonathan Neely: Com.
Jonathan Neely: You are cautioned not to place undue reliance on forward looking statements forward looking statements. During this conference call speak only as of the original date of this call or any earlier date indicated in such statement and we undertake no obligation to update or revise any of these statements.
Jonathan Neely: 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.
Ramy A. Mahmoud: Thank you Jonathan and thank you to everyone listening for joining us. This morning. We appreciate you joining us for our first quarter 2024 update.
Ramy A. Mahmoud: Starting on slide three.
Ramy A. Mahmoud: I'll start with a brief outline of what we'll cover during our call today to start off I'll review three key takeaways from today's call and discuss our initial plans to reach out to our Emt and allergy specialist physician audience with extensive new clinical profile, including communication of data showing strong efficacy in chronic sinusitis, which our market research.
Ramy A. Mahmoud: Indicators, a leading driver of prescribing behavior next.
Ramy A. Mahmoud: Next to Jonathan Neeley, our VP of Investor Relations and business development, who will review, our first quarter 2024 performance and our financial guidance for full year 2024.
Jonathan Neely: Finally, I will return to review information about our peak net revenue estimates for exams and the profitability targets that we described on Rx hands chronic sinusitis launch call in April and we'll wrap up the call and take your questions.
Jonathan Neely: Turning to slide four will go into more detail in a moment, but I'd like to highlight three key takeaways from today's presentation.
Speaker Change #155: 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.
Jonathan Neely: James data suggest the chronic sinusitis is currently being diagnosed by health care providers at least 10 times more frequently than nasal polyps.
Following our national launch meeting the week of April 8th, 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 Salesforce 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 million in producing positive income from operations for full year 2025. Second, thanks to the efforts of our team, we have a significantly stronger base to build on than we did at the start of 2023.
James: Following our national launch meeting the week of April as we have now fully engaged our sales team and our chronic sinusitis launch with training and a full set of materials.
James: 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 million and producing positive income from operations for full year 2025.
James: Second thanks to the efforts of our team we have a significantly stronger base to build on and then 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 expansion revenue while preparing our organization to seize the greatly expanded opportunity in chronic sinusitis. We successfully met or exceeded the financial expectations we set for the last five consecutive quarters of revenue achievement, aggressive operating expense reductions, and improvements in our average net revenue per prescription. Third, 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.
CEO: When I started as CEO, we implemented an initiative to greatly increase our operating efficiency and to stabilize <unk> revenue, while preparing our organization to seize the greatly expanded opportunity in chronic sinusitis.
CEO: We successfully met or exceeded our financial expectations, we set for the last five consecutive quarters of revenue achievement aggressive operating expense reductions and improvements in our average net revenue per prescription.
Speaker Change #149: Third the combination of expanded market opportunity and improved base business fundamentals has set up the opportunity for <unk> to return to strong growth in 2024 weeks.
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 enhanced net revenues to increase by 20% to 34% for full year 2024 compared to full year 2023. We also believe that enhanced net revenue growth can be achieved with modest incremental operating expense increases to support promotional efforts while leveraging our existing commercial infrastructure. Turning to slide five.
Speaker Change #158: We have now announced our initial guidance for full year 2024, net revenues and total operating expenses.
Speaker Change #152: Mindful that the full launch of the <unk> indication started in mid April we expect <unk> net revenues to increase by 20% to 34% for full year 2024 compared to full year 2023.
Speaker Change #146: We also believe that <unk> net revenue growth can be achieved with modest incremental operating expense increases to support promotional efforts, while leveraging our existing commercial infrastructure.
Speaker Change #160: Turning to slide five.
Last week, we announced a $55 million registered direct financing, which was led by Nanta Hela and D.E. Shaw and had participation from both new and existing healthcare focused investors. As a result of this funding, OptiNose now has cash and cash equivalents of approximately $100 million. Following on the recent approval of the chronic sinusitis indication, this funding 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 Change #147: Last week, we announced a $55 million registered direct financing, which was led by <unk> and D E Shaw and had participation from both new and existing health care focused investors.
Speaker Change #148: As a result of this funding <unk> now as cash and cash equivalents of approximately $100 million.
Speaker Change #161: 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.
As 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 31st 2025 financial statements, which is expected to occur in March of 2026. Additionally, the minimum liquidity covenant will be reduced from $30 million to $20 million, following the date of the first quarterly payment principal, which is due on September 30 2025. We also extinguished $4.7 million of outstanding amendment and waiver fees, which have now been converted to equity.
unknown: As 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.
unknown: Additionally, the minimum liquidity covenant will be reduced from 30 million to $20 million. Following the date of the first quarterly payment of principal which is due on September 32025.
Speaker Change #157: We also extinguished $4 $7 million 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 XHANTS launch plan. Turning to slide 7 in our launch plan, In the second quarter of this year, we are leveraging four major tactics to launch Expansion 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.
Speaker Change #150: As a result of this financing in our revised debt agreement <unk> is in a greatly strengthened financial position to consider multiple future opportunities for value creation with our initial focus remaining squarely on our <unk> launch plan.
Speaker Change #150: Turning to slide seven and our launch plan.
Speaker Change #151: In the second quarter of this year, we are leveraging four major tactics to launch <unk> into this major new market opportunity. These.
Speaker Change #167: These include our sales force non personal promotion peer to peer education and presence at medical meetings.
Speaker Change #156: Let's begin with our 75 person sales organization in.
In the second quarter, 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 enhanced samples to stimulate additional physician and patient trials. In a highly symptomatic condition like chronic sinusitis, samples can be effective in facilitating new product adoption.
Speaker Change #165: In the second quarter, our team plans to reach approximately 7500 target health care providers and make over 35000 total sales calls.
Speaker Change #168: We're also supplying to field with 50% more <unk> samples to stimulate additional physician and patient trial.
Speaker Change #153: In a highly symptomatic condition might 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, and we expect the momentum in ExhansPrescribing to build over time with continued Salesforce 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.
Speaker Change #162: It's still very early days for us in the field, but initial feedback has been quite positive execution has been strong and we expect the momentum in <unk> prescribing to build over time with continued sales force engagement.
Speaker Change #177: We are supplementing the field force with non personal promotion targeting a total of 22000 of the highest potential largely specialty prescribers.
Speaker Change #153: These tactics include digital media search engine marketing and social media.
In the second quarter, we plan to generate 1.5 million healthcare provider impressions and over 50,000 customer engagements using this approach. We'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 second quarter, we plan to reach over 1,000 healthcare providers to highlight the new Exant clinical profile and discuss unmet needs and diagnostic criteria, which are important considerations for facilitating appropriate patient identification in the clinic.
unknown: In the second quarter, we plan to generate $1 5 million health care provider impressions and over 50000 customer engagements using this approach.
Speaker Change #154: We'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.
Speaker Change #180: The second quarter, we plan to reach over 1000 health care providers to highlight the new <unk> 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 second quarter, including 10 national and 20 regional events for ENTs and allergens. 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 EXANSE, and reinforcing our leadership and visibility in the chronic sinusitis space. Taken together, these four tactical pillars are essential elements of our launch plan.
Speaker Change #173: Lastly, we're planning a strong presence at medical meetings during the second quarter, including 10 national in 'twenty regional event for <unk> and Allergists.
Speaker Change #174: 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.
Speaker Change #171: These events are aimed at disseminating our message about the recent approval and new clinical trial data reinforcing the clinical benefits of <unk> and reinforcing our leadership and visibility in the chronic sinusitis space.
Speaker Change #154: Taken together these four 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 an overall improvement in the rate of written prescriptions that are ultimately filled, and the rate at which insurance coverage and copay support are correctly applied to each prescription. Our generous co-pay support group program will continue to facilitate patient starts, with many patients being offered $0 co-pays in their first month.
Speaker Change #175: 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 an insurance coverage and co pay support our correctly applied to each prescription.
Presenter: Our generous co pay support program will continue to facilitate patient starts with many patients being offered a zero dollar co pays in their first 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 XHANSE, even if insurance coverage is still pending. We're also aware that it can often require five to seven calls to new physicians before the initiation of product trials, and that successful product trials are a precursor to consistent adoption over time. We believe our planned efforts will get the ball rolling and result in gradually accelerating product uptake.
Speaker Change #176: So many of these new initiations are not captured by <unk> that can help patients and providers gain personal experience with the benefits of enhanced even if insurance coverage is still pending.
Speaker Change #172: We're also aware that it can often require five to seven calls on new physicians before initiation of product trials and Thats successful product trials are a precursor for consistent adoption over time we.
Speaker Change #170: We believe our planned efforts, we will get the ball rolling and resulting 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 first few months following approval, are expected to drive an uptick in enhanced growth this year and ultimately deliver at least $300 million in peak sales in the peak year. I would now like 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 9th. Jonathan
Speaker Change #178: All of these activities in the context of our preexisting payer access which includes broad commercial coverage and which we expect to typically adapt to include our new indication over the first few months. Following approval are expected to drive an uptick in <unk> growth this year and ultimately deliver at least $300 million in peak sales.
Presenter: In peak year.
Presenter: 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 9th Jonathan.
Thank you, Ramy. Turning to slide nine, we are encouraged by our first quarter 2024 financial results. Regarding revenue, OptiNose recognized $14.9 million of expansion net revenue in the first quarter of 2024, a 26% increase compared to first quarter 2023 net revenues of $11.8 million. As discussed on our last earnings call, strength and demand afforded us the opportunity to make gradual changes that we have implemented that have had a positive influence
Jonathan Neely: Thank you Rami turning to slide nine we are encouraged by our first quarter 2024 financial results regarding.
Jonathan Neely: Regarding revenue <unk> recognized $14 9 million of <unk> net revenue in the first quarter of 2024, 26% increase compared to first quarter 2023, net revenues of $11 $8 million.
In late 2023 and early 2024, we made gradual revisions to our copay assistance program and implemented new hub services. These changes have prioritized growth in profitable prescriptions and have reduced both the number and proportion of unprofitable prescriptions. The net result is evident in the enhanced 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 enhanced average net revenue per prescription for the first quarter of 2024 was $227 per prescription.
Jonathan Neely: As discussed on our last earnings call strengthened demand afforded us the opportunity to make gradual changes that we have that have had a positive influence on profitability in late 2023. In early 2024, we may gradual revisions to our co pay assistance program and implemented new hub services.
Speaker Change #187: These changes have prioritize growth and profitable prescriptions and a reduced both the number and proportion of unprofitable prescriptions.
Speaker Change #163: The net result is evident in <unk> net revenue per prescription.
Speaker Change #164: 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 <unk> average net revenue per prescription for the first quarter of 2024 was $227 per prescription.
This is a 63% increase compared to $139 of estimated average net revenue per prescription in the first quarter of 2023. In addition to the changes in copay assistance and the implementation of Hub services, we believe the disruption in services that changed the healthcare claims processor for our vendor that administers the enhanced copay support program hindered access to our copay benefit for uncovered patients. We believe this disruption had a favorable effect on enhanced net revenue per prescription and expect it to be isolated to first quarter 2024. Finally, as we reported earlier, OptiNose recognized $21.7 million of SG&A plus R&D expenses in the first quarter of 2024.
change healthcare: The 63% increase compared to $139 of estimated average net revenue per prescription in the first quarter of 2023. In addition to the changes in co pay assistance and the implementation of hub services. We believe the disruption in services at change healthcare claims processor for our vendor that administers the <unk> co pay support program hindered.
change healthcare: Access to our co pay benefit.
Speaker Change #163: For uncovered patients. We believe this disruption had a favorable effect on SaaS net revenue per prescription and expect it to be isolated to first quarter 2024.
Speaker Change #166: Finally, as we reported earlier <unk> recognized $21 $7 million of SG&A, plus R&D expenses in the first quarter 2024. This is approximately a $3 million or a 11% decrease compared to first quarter 2023 expenses of $24 5 million.
This is approximately a $3 million, or 11%, decrease compared to first quarter 2023 expenses of $24.5 million. Last week, we announced our initial financial guidance for full year 2024 enhanced net revenue and full year 2024 operating expenses. In addition, given the stronger than expected performance in the first quarter of 2024, we increased our expectation for full year 2024 expanse net revenue per prescription. First, for the full year of 2024, we expect total operating expenses to be between $95 to $101 million, of which approximately $6 million is expected to be stock-based compensation.
Speaker Change #182: Last week, we announced our initial financial guidance for full year 2024, <unk> net revenue and full year 2020 for operating expenses. In addition, given the stronger than expected performance in the first quarter 2024, we increased our expectation for full year 2024, <unk> net revenue per prescription.
Speaker Change #169: First for the full year of 2024, we expect total operating expenses to be between $95 million to $101 million of which approximately $6 million is expected to be stock based compensation.
Second, we anticipate strong growth for ExpanseNet revenues given the expanded market opportunity available in CS. Our expectation for ExpanseNet revenue for full year 2024 is between $85 million and $95 million. Finally, we now expect Expanse net revenues per prescription to exceed $230 for the full year of 2024. Previously, we expected Expanse net revenues per prescription to be approximately $220 for the full year of 2024. I'm going to turn the call back over to Ramy for his closing remarks. Thank you, Jonathan. Turning to slide 13.
Speaker Change #185: Second we anticipate strong growth for SaaS net revenues given the expanded market opportunity available on CFS, our expectation for <unk> net revenue for full year 2024 is between $85 million to $95 million.
SaaS: Finally, we now expect <unk> net revenues per prescription to exceed $230 for the full year of 2024 previously we expected SaaS net revenues per prescription to be approximately $220 for the full year 2024.
Ramy A. Mahmoud: I'll turn the call back over to Rami for closing remarks Rami.
Jonathan: Jonathan turning to slide 13.
In April, we provided a financial outlook for expansion 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 investment 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.
Rami: In April we provided our financial outlook for <unk> and chronic sinusitis that we believe we can meet or exceed within our base business.
Jonathan: This is 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 future expansion of our sales organization.
We may consider future expansion of our sales organization to further accelerate our launch. Although 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 exams for a significantly larger population of approximately 3 million 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.
Speaker Change #179: To further accelerate our launch.
Speaker Change #184: Although the size of our sales team is remaining steady but will be dramatically different is the message. We can convey to doctors as we promote <unk> for a significantly larger population of approximately 3 million patients cared for in our specialty segment.
Speaker Change #186: Importantly, we believe that a much broader range of physicians, commonly make the diagnosis of chronic sinusitis in the diagnosis of nasal polyps. This includes prescribers, who are not equipped to routinely perform nasal endoscopy in office procedure, which is often relied on to confirm a diagnosis of nasal polyps.
This includes prescribers who are not equipped to routinely perform nasal endoscopy in their office, a procedure which is often relied on to confirm a diagnosis of a nasal polyp. With this in mind, we believe we can realistically achieve peak net revenues of at least $300 million and produce positive income from operations for full year 2025. Turning to slide 14.
Speaker Change #169: With this in mind, we believe we can realistically achieve peak net revenues of at least $300 million and produce positive income from operations for full year 2025.
Speaker Change #169: Turning to slide 14 in.
In 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 million.
Speaker Change #189: In addition to the potential within our base business. We believe there is 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.
Speaker Change #196: 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.
Speaker Change #195: 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 million and.
Speaker Change #195: And we will carefully consider if and when this incremental investment is appropriate.
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 primary care prescribers. We could pursue this opportunity either by adopting alternative selling models like digital promotion or through direct selling partnerships to access an additional 7 million actively diagnosed and treated patients with chronic sinusitis. In future, we could also invest in capital efficient approaches to activating the 20 million additional patients with chronic sinusitis who are symptomatic but are not actively seeking care each year.
Speaker Change #189: Next we believe our product is well suited to support outreach to our 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 million actively diagnosed and treated patients with chronic sinusitis.
Speaker Change #192: In future, we could also invest in capital efficient approaches to activating the 20 million additional patients with chronic sinusitis, who are symptomatic, but not actively seeking care each year.
Based on the direct-to-consumer pilot data that we have, we believe the Xans product profile is well-suited to support strong patient activation. Third, I'd like to note that, to date, we have not invested significant energy in establishing international partnerships for Exantus, but we have maintained patents in select major markets. Lastly, we aim to leverage our existing infrastructure, particularly our commercial infrastructure, to generate synergies by working on additional products. OptiNose is establishing strong infrastructure, experience, and competencies in what we consider the comparatively blue ocean ENT and allergy specialty space.
Speaker Change #198: Based on direct to consumer pilot data that we have we believe the <unk> product profile is well suited to support strong patient activation.
Speaker Change #200: Third I'd like to note that to date, we have not invested significant energy in establishing international partnerships. For example, but we have maintained patents in select major markets. These.
Speaker Change #183: These represent another potential incremental source of value.
Speaker Change #191: Lastly, we aim to leverage our existing infrastructure, particularly our commercial infrastructure to generate synergies by working on additional products.
unknown: <unk> is establishing strong infrastructure experience and competencies in what we consider the comparatively blue Ocean Emt and allergy specialty space.
As we generate income from operations, which we expect for full year 25, and continue to strengthen the organization, OptiNose has the 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 needs in our specialty areas. Turning to slide 15.
Speaker Change #194: As we generate income from operations, which we expect for full year 'twenty five and continue to strengthen the organization.
unknown: <unk> has potential to become the commercialization or development partner of choice for companies in the specialty space.
Speaker Change #199: 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 roots and build a pipeline of new and innovative treatments to address unmet need in our specialty arena.
Speaker Change #199: 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 the potential to reshape our business starting in the second quarter of this year and for years into the future. We are pleased with our success in executing our pre-launch operating strategy through 2023 in the first quarter 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 the exams as the first prescription treatment for one of the most common diseases diagnosed in adult outpatient medicine.
Speaker Change #193: Before moving to take any questions I would like to reiterate the significance of the opportunity in front of us, which we believe has potential to reshape our business starting in the second quarter of this year and for years into the future.
Speaker Change #193: We're pleased with our success in executing our prelaunch operating strategy through 2023 in the first quarter of 2024.
Speaker Change #197: We achieve 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 <unk> 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, positions 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 capability. 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.
unknown: We believe the launch opportunity we are just getting off the ground coupled with our recent financing position us well to build a profitable <unk> and allergy focused business by accessing greatly expanded net revenue potential through inefficient existing base of commercial capabilities.
Speaker Change #201: 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 addition in addition to what we can access on our own and the specialty segments.
With that, I'd like to thank you for your attention and open up the call for Q&A. As a reminder to ask, dial 1 on your telephone and wait for your name for all your questions. Dial 1-1.
Speaker Change #197: With that I'd like to thank you for your attention and open up the call for Q&A.
Speaker Change #197: As a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
Speaker Change #197: Please standby, while we compile the Q&A roster.
[inaudible] And our first question is from Thomas Flaten with Lake Street Capital. Good morning. I appreciate you guys taking the time to answer 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 queue about the change healthcare 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 be and what the cadence is going to be over the course of the year. We're used to seeing a huge swing upward in the second quarter, but I'm not sure if we should be thinking the same way for this year. Any help there would be great.
Speaker Change #197: And our first question comes from Thomas Flaten with Lake Street Capital Markets. Your line is now open.
If you want to pick up on the parts about Change Harris, Karen, I was talking about the cadence. Well, so we do believe changing healthcare has 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 first quarter of 2024 than we did in prior years. So we do think there's still a seasonal trend, if you will, where the first quarter will generally be lower than subsequent quarters.
Thomas Flaten: Good morning, I appreciate you guys taking the questions.
Thomas Flaten: I'm just trying to digest the significant upside to the average revenue per prescription, particularly in light of the comments made in the Q about the change healthcare potentially one time upside.
Speaker Change #197: I was just curious if you could help us maybe map out how you expect.
Speaker Change #197: The average revenue per prescription to what the cadence is it going to be over the course of the year, we're used to seeing huge swing upward in the second quarter, but I'm not sure. If we should be thinking the same way for this year any help there would be greatly appreciate it.
Speaker Change #205: I'll pick up the parts about change healthcare and I'll talk about the cadence.
Speaker Change #197: So we do believe change health or health care had an effect, but as we pointed out in our comments Tom.
Tom: It's not the only reason that we had a higher average net revenue per prescription in the first quarter of 2024.
Speaker Change #203: And then we did in prior years so we.
Speaker Change #208: We do think there is still a.
Tom: A seasonal trend if you will where first quarter will generally be lower than subsequent than subsequent quarters. However, what we've done is we've 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 and so in terms of thinking about the cadence within the year relative to <unk>.
However, what we've done is we've 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. 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.
Speaker Change #204: <unk> prior I don't think what we're projecting is a M.
Speaker Change #202: Really significant.
Speaker Change #209: The increase in revenue per prescription moving from Q1 into the rest of the year, but we do believe that the changes that we've put into the business proactively we're going to have a positive influence on revenue per prescription on a year over year basis, as we move through the year.
But we do believe that the changes that we put into the business proactively are 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 $220 to at least or exceed $230 per prescription. So we still do think that there's going to be improvement within the year. And then another thing I saw in the queue was that there was a comment that the number of covered lives that have access to X hands decreased from 80% to 70%.
Speaker Change #210: But yes, we've moved our estimate now up from approximately $220 to at least or to exceed $230 per prescription.
A student: A student is still do think that theres going to be improvement within the year.
I was curious; you can comment on that. Yeah, 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.
Speaker Change #202: And then.
Speaker Change #242: The other thing I saw in the Q was that there was a comment that you are the number of covered lives that have access to X <unk> decreased from 80% to 70% I was curious if you can comment on that.
Speaker Change #212: Yes, I think thats more a consequence of the way in which we are measuring. It then it is a consequence of any change in coverage.
Speaker Change #212: 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 a harder diagnosis to make and less often coded for.
Speaker Change #202: The.
Speaker Change #202: The intent has always been you are the.
Speaker Change #207: Expectation that we had was always that our number of covered lives wouldn't change materially with the new indication, but we do expect as in.
Speaker Change #207: Is an improvement.
Speaker Change #214: 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 harder.
Speaker Change #207: <unk> to make it less often quoted for.
And now to also have a chronic sinusitis indication, which is much more broadly coded for in outpatient visits. I think, I think historically, when we talked about, you know, the percentage of lives that are, you know, covered, or implants that cover exams, I think we historically focused on commercial only, but I think we've moved to providing a measure that's for all insurance plans, whether it's commercial or government. It makes sense. And then there was one final quick one.
Speaker Change #213: And now to be able to also have a chronic sinusitis indication, which is much more broadly coded for in outpatient visits.
Speaker Change #219: I think historically when the tax yes, I think historically when we've talked about <unk>.
Speaker Change #217: Percentage of lives that are covered are in plans that cover <unk>.
Speaker Change #218: Historically focused on.
Speaker Change #206: Commercial only but I think we've moved to providing a measure that's.
Speaker Change #215: All insurance plans, whether it's commercial or government.
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 No, 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. Thomas Flaten, Schuyler Broek, OptiNose Inc. Our next question: David Amsellem with Piper Sandler, your line: Hi, this is Schuyler. I'm for David.
Tom: Thanks, Tom and then one final quick one the samples that you are handing out is that a full 30 day dose R. R.
Tom: 30 days of doses available in that or is there a smaller quantity of drug in the samples.
Tom: No. The samples most of the samples that we are handing out or a specific sample put up which is not a full 30 days. It's just enough to get you started.
Speaker Change #222: And hopefully give you time to be able to receive your prescription from whichever pharmacy, including mail order that you might be accessing.
Tom: Understood. Thanks, Ross Thanks, so much.
Tom: Thanks, Tom.
Tom: Thank you one moment for our next question.
David A. Amsellem: Our next question comes from David <unk> with Piper Sandler Your line is now open.
Can you speak anecdotally about what you've been seeing on the payer landscape front since the expanded label? Have there been any roadblocks to getting coverage for patients for 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 water? So Schuyler, thanks for your questions. I'll start with the second one.
Schuyler van den Broek: Hi, This is skyler on for David can you speak anecdotally to what you've been seeing on the payer landscape with the expanded label have there been any roadblocks to getting coverage for patients with nasal polyps.
David: And then for net revenue per Rx in the long term how do you think that is kind of all within the context of the latter label.
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 copay support program and sort of other business actions, but not really a function of the indication for which the drug is prescribed. With regard to anecdotes about insurance coverage, all I can share with you is, in fact, just anecdotes.
Schuyler van den Broek: So Scott Thanks for your questions I'll start with the second one with regard to average net revenue per prescription.
Scott: I don't I don't think we view that as something that is a.
Scott: A function of the label change it's been very sensitive to changes we've made in our co pay support program.
Speaker Change #224: And sort of other sort of business actions, but not really a function of the indication for which the drug is prescribed with regard to anecdotes about insurance coverage.
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 Change #224: All I can share with you is in fact, just anecdotes is premature for us to have sort of broad patterns established since our launch there just hasnt been enough elapsed time.
Scott: And of course, there are thousands of different insurance plans out there I can't speak to all of them.
I can tell you we have gotten specific anecdotal reports of the new indication being added 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 to the current prior authorization criteria. Got it. That's helpful. And then, on the sales force, I think you mentioned potential expansions in the future. Can you talk about what factors would inform that decision?
Speaker Change #216: I can tell you we have gotten specific anecdotal reports of the new indication being added in two prior authorization forms exactly as we've discussed before.
Speaker Change #216: We would expect to happen over a number of months following the approval.
Speaker Change #216: 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 Change #216: Got it that's helpful. And then one more on the sales force I think you mentioned potential expansions in the future.
Speaker Change #216: Factors that inform that.
Yeah, I think we're looking to see the results of our initial promotional activities. You know, 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 the 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 Change #216: Yes, I think.
Speaker Change #220: We're looking to see the results of our initial promotional activities.
Speaker Change #227: We're following it closely with some fairly intense analytics.
Speaker Change #231: And as we get a better sense of the uplift that we're generating.
Speaker Change #227: And these.
Speaker Change #221: These are the drivers that are producing the best ROI.
Speaker Change #225: Then we will use that information to inform the magnitude and the timing of any changes we make in our promotional activities.
Speaker Change #230: Got it helpful. Thank you.
Speaker Change #221: Thank you.
Helpful. Thank you. As a reminder, to ask a question, just press 1-1 on your telephone.
Speaker Change #221: As a reminder to ask a question. Please press star one on your telephone again that is star one wanted to ask a question.
Again, that is Star 1-1 to ask. Our next question comes from Glenn Santangelo on Jefferies. Your line is now open. Oh, yeah, thanks for taking my question. Hey, Ramy, I also wanted to follow up on this, Transcribed by https://otter.ai. I'm trying to, you know, I thought it was going to be a relatively quick process, given the payer's familiarity with the product. Context with that, with the full year fiscal 24 guidance and maybe the decision to leave the commercial infrastructure as is. Time.
Speaker Change #234: Our next question comes from.
I guess what we're all trying to figure out is sort of the cadence. You know, when those payer contracts can be amended and when we should start to expect some acceleration in revenue. Well, Glenn, thank you for the question. This might sound obvious, but we don't directly control the pace at which these changes are made in 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, you know, I have concrete examples of cases where changes have already been made. Other examples where it hasn't been made.
Speaker Change #221: Glen Santangelo with Jefferies. Your line is now open.
Glen Santangelo: Yes. Thanks for taking my question, Hey, Rami I also wanted to follow up on in terms of what Youre seeing in terms of payer coverage.
Glen Santangelo: You said youre gradually seeing the new indication added can you give us a sense for maybe how long that will take because in China 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.
Glen Santangelo: The full year fiscal 2000 and for guidance.
Glen Santangelo: And maybe the decision to leave the commercial infrastructure as is at this point in time.
Speaker Change #228: Guess, what we're all trying to figure out sort of the cadence of which.
Speaker Change #228: Those those payer contracts can be amended and when we should start to expect some acceleration on the revenue side.
Glenn: Well so so Glenn thank you for the question.
Speaker Change #228: This might sound obvious but.
Speaker Change #228: We don't directly control the pace at which these changes are made at various insurance plans and there are.
Glenn: There's a small number of major pbms and insurers, but there are thousands and thousands of insurance plans.
Speaker Change #240: And I have concrete examples of cases, where the changes have already been.
Speaker Change #229: <unk> made other examples where it hasnt been made so we are estimating that it could take in some plans a few weeks and some plans some months for these changes ultimately to rollout and 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 can be fully aware of.
So, you know, we are estimating that it could take, you know, in some plans, a few weeks, in some plans, some months for these changes, you know, ultimately, to roll out. And 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, you know, we've done everything we could to facilitate their ability to make those changes. But, you know, at the end of the day, it's not something we directly control.
Speaker Change #232: Of the new indication that was coming.
Speaker Change #233: And we've done everything we can to facilitate their ability to make those changes.
Speaker Change #237: At the end of the day, it's not something we directly control.
Speaker Change #233: And.
And, you know, we, you know, you asked sort of, "When can we start seeing a difference in revenue?" We've tried to give you guidance that I think makes it clear that we're expecting, you know, an increase in revenue this quarter. So in the second quarter, we're expecting revenue to start increasing. And we expect it to increase, you know, over the remainder of the year, ultimately reaching 85 to $95 million for calendar 2024, which is meaningfully higher than 2023.
Speaker Change #233: You asked sort of when can we start difference in revenue.
Speaker Change #233: We've tried to give you guidance that I think makes it clear that we're expecting.
Speaker Change #246: An increase in revenue this quarter. So in second quarter, we're expecting revenue to start increasing and we expect it to increase over the remainder of the year ultimately, reaching $85 to $95 million for calendar 2024, which is meaningfully higher than 2023.
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 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 I don't think it's a contracting discussion. I think it's more having processes where the insurers reflect the state of the label of the product and have their business processes reflect that. It's not a renegotiation.
Speaker Change #233: Yes.
Speaker Change #233: Go ahead.
Speaker Change #233: You did ask a question about yes, you're asking the question about the cadence of the 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.
Speaker Change #233: Largely contemplate the expanded label they contemplate rebates whenever the product is reimbursed for FDA approved indications that are on the label.
Speaker Change #233: I don't think.
Speaker Change #248: It's a contracting discussion I think it's more having processes at the insurers reflect the.
Speaker Change #235: The state of the label the product and having.
Speaker Change #243: Having having their business processes reflect that its not not not a renegotiation.
Speaker Change #239: Maybe just two other quick ones from me and then I'll hop off the total scripts and this quarter. It looked like they were down a fair amount based on that average rent per script. I was wondering if you can sort of comment on that and then secondly on <unk>.
Speaker Change #247: 300 million peak sales number could you, maybe Ron or John can 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.
Speaker Change #241: Gripped in average revenue per script perspective. Thanks.
Transcribed by https://otter.ai, Script and Average Web Per Script Perspective. Thanks. Sure. So, in terms of, you know, the prescriptions on a quarterly basis, you know, as we described, we've made some changes to our copay assistance program late in 2023 and again in early 2024 that, you know, we believe have, you know, kind of focused us on growing the profitable portion of our business and, you know, has reduced the number and proportion of unprofitable prescriptions.
Speaker Change #236: Sure. So I mean in terms of the prescriptions on a quarterly basis I think.
Speaker Change #235: As we described.
Speaker Change #238: Made some changes to our co pay assistance program.
Speaker Change #238: Late in 2023 and again in early 2024.
Speaker Change #250: We believe is kind of focused us on growing the profitable portion of our business.
Speaker Change #238: And has reduced the number and proportion of unprofitable prescription. So yes. The year over year result, if you look at prescriptions.
So, you know, the year-over-year result, you know, if you look at prescriptions, you're down, I think, almost 23% on a year-over-year basis, but importantly, you know, there are prescriptions leaving the business that, on net, improve our revenue performance by them no longer being filled. So, you know, 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 Change #238: Youre down I think almost 23% on a year over year basis, but importantly.
Speaker Change #253: Their prescriptions, leaving the business.
Speaker Change #238: On net.
Speaker Change #238: Prove 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.
And 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 of unprofitable or even negative revenue prescriptions. We also 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.
Speaker Change #238: Glen, Let's just just to add a little bit to that you might have sort of missed it in the earlier comments, but.
Glen Santangelo: We are reducing the number of unprofitable or even negative revenue prescriptions. We also have.
Glen Santangelo: Yeah.
Glen Santangelo: 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 per grow profitable.
Speaker Change #255: The other thing I'll mention.
Speaker Change #252: I'm just sort of just as a reminder is that.
Speaker Change #252: The tracking of prescriptions by external third party providers.
Speaker Change #244: Is imperfect and it's always been imperfect and it varies over time, how closely mirrors, our actual numbers, but one of the things I highlighted in my earlier comments is that new initiations, which disproportionately we're trying to drive with the new.
And it's always been imperfect, and it varies over time how closely it mirrors our actual numbers. But one of the things I highlighted in my earlier comments is that new initiations, which, you know, disproportionately we're trying to drive with the new launch, new initiations that have a zero dollar co-pay may not be captured by third-party data providers at all. So they will be invisible to you.
Speaker Change #245: New initiations that have a zero dollar copay may not be captured by third party data providers at all so it will be invisible to you.
So I'll give you one last comment on the guide for the year and the implications for, you know, prescription growth and, you know, revenue per prescription growth. Yeah, yeah, given that we've provided a range for revenues and a floor, if you will, for revenue per prescription, I think if you reverse the math, you can derive that, you know, we're expecting both prescriptions to grow on a year over year basis.
Speaker Change #245: So I'll give you one last I'll give you one last comment on the on the guide for the year and the implications for prescription growth and.
Speaker Change #245: Revenue per prescription growth yes.
Speaker Change #256: Given that we've provided a range for revenues and a floor. If you will for revenue per prescription I think.
Speaker Change #245: If you reverse into the math.
Speaker Change #257: You can derive that we're expecting both prescriptions to grow on a year over year basis.
As well as revenues growing on a year over year basis and along with, you know, the kind of revenue per prescription. All right, thank you very much. Glen, the last thing I'll add is that you asked about 300 million.
Speaker Change #245: As well as.
Speaker Change #245: Revenues to grow on a year over year basis.
Speaker Change #245: Along with kind of the revenue per prescription.
Glenn: Alright, Glenn Thank you Rob I'm.
Speaker Change #245: I'm sorry, Glenn the last thing I'll add is you asked about the $300 million.
My view is that the growth to get us from 2024 out to peak year is growth in the use of the product, 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 nine months or so.
Glenn: My view is that.
Glenn: 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.
Glenn: There were a lot of levers to pull there sort of in the last I don't know say nine months or so.
But in the future, primarily, growth will come from increased uptake of the product. Perfect. Thanks a lot.
Speaker Change #251: But in the future and primarily the growth will come from increased uptake of the product.
Speaker Change #251: Perfect. Thanks, a lot.
Thank you. Please take a moment for our next question. Our next question comes from Matthew Caulfield. The Wainwright-Jarlones Note. The Wainwright-Jarlones Note
Glenn: Thank you one moment for our next question.
Glenn: Okay.
Glenn: Our next question comes from Matthew Coffield with HC Wainwright. Your line is now open.
Hey, good morning, guys. Thanks for taking our question. And congrats on the successful launch; 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.
Matthew Coffield: Hey, good morning, guys. Thanks for taking our questions and congrats on the successful launch so far.
Matthew Coffield: So appreciate in the specialist focused efforts targeted towards allergists and E&ps.
Matthew Coffield: 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 of any future sales efforts, presumably primary care could be prescribing <unk>.
Speaker Change #254: Not being kind of the current focus.
Yeah, 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 universe, but it's not a huge number.
Matt Smith: Yes, so Matt.
Matt Smith: I mean, we haven't made a decision yet about sort of how we'll report out on the.
Matt Smith: Sort of indicators for future growth, but as you said our efforts right now are focused primarily on our specialty audience. We do have some primary care physicians in our called on University, who is not a huge number and.
And 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 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. Okay, fair enough.
Matt Smith: And 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 in the sort of the manner in which the product is being used in the different segments of 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 <unk>.
Matt Smith: Prescribers specialty in the near future at least.
Very helpful and very excited to see the launch. Congratulations, guys. Thanks again, Matt.
Matt Smith: Okay fair enough very helpful and very excited to see the launch congrats guys. Thanks.
Matt Smith: Thanks again, Matt.
Matt Smith: Thank you.
Showing no further questions at this time, I would now like to turn it back to Ramy Mahmoud, CEO, for closing. I'd like to thank you all for joining us this morning. I appreciate your attention and help, and I hope you share our excitement about 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. We look forward to getting back with you again in August to share our second quarter results. This concludes today's conference. Thank you for participating.
Matt Smith: I am showing no further questions at this time I would now like to turn it back to Rami Mahmud CEO for closing remarks.
Ramy A. Mahmoud: Great I'd like to thank you all for joining US. This morning appreciate your attention and help and I hope you share our excitement and put 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 that we've accomplished.
Speaker Change #258: In the last few months and 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 second quarter results.
Speaker Change #258: This concludes today's conference call. Thank you for participating you may now disconnect.