Q4 2023 OptiNose Inc Earnings Call
Unknown Executive: www.opti-nose.com Good day, and thank you for standing by. And welcome to the OptiNose fourth quarter 2023 conference call. At this time, all participants are in a listen-only mode.
Okay.
Good day, and thank you for standing by and welcome to the fourth quarter 2023 conference call.
This time, all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During the session you will need to press star one on your telephone you will then hear an automated message advising your hands.
Unknown Executive: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised.
Unknown Executive: To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Jonathan Neely, Vice President, Investor Relations and Business Development. Please go ahead.
To withdraw your question. Please press star one again, please be advised that today's conference is being recorded I would now like to hand, the conference over to your first speaker today, Jonathan Neely, Vice President Investor Relations and business development. Please go ahead.
Jonathan Neely: Good morning, and thank you for joining us today as we review OptiNose's fourth quarter and full year 2023 performance and our plans for the year ahead. I'm joined today by our CEO, Dr. Ramy Mahmoud, and our Chief Commercial Officer, Paul Spence. The slides that will be presented on this call can be viewed on our website, OptiNose.com, in the 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.
Good morning, and thank you for joining us today as we review often knows this fourth quarter and full year 2023 performance and our plans for the year ahead.
I'm joined today by our CEO Dr. Rami.
Our chief commercial officer, Bill Spence the slides that will be presented on this call can be viewed on our website. After notes 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.
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 that is filed with the SEC and available at their website, sec.gov, and on our website at optinose.com. Please exercise caution not to place undue reliance on forward-looking statements. The forward-looking statements during this conference call speak only as of the original date of this call or any earlier date indicated by 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. Okay. Thank you, Jonathan.
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 Optum knows his most recent Form 10-K that is filed with the SEC and available at their website at SEC Gov and on our website at <unk> Dot com.
You are cautioned not to place undue reliance on forward looking statements forward looking statements. During this conference call speak only as of the original date of this call or any earlier date indicated by such statements.
And we undertake no obligation to update or revise any of these statements.
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 fourth quarter and full year 2023 update. So, starting on slide three, and we'll go into more detail in a moment, but I'd like to highlight four key takeaways from today's presentation. First, I would like to commend our team for successfully executing our 2023 operating strategy. That strategy was to greatly increase our operating efficiency and to stabilize Exhans revenue while preparing our organization to seize the greatly expanded opportunity created by potential approval of Exhans as the first prescription treatment for one of the most common diseases diagnosed in adult outpatient medicine. We successfully met or beat the financial expectations we set for 2023, including the last four consecutive quarters of revenue achievement, aggressive operating expense reduction targets, and improvement in our average net revenue per prescription while preparing our organization
Great. Thank you Jonathan and thank you to everyone listening for joining us. This morning. We appreciate you joining us for our fourth quarter and full year 2023 update.
So starting on slide three and will go into more detail in a moment, but I'd like to highlight four key takeaways from today's presentation first I'd like to commend our team for successfully executing our 2023 operating strategy that strategy was to greatly increase our operating efficiency and to stabilize exceedance revenue all preparing our organization.
To seize the greatly expanded opportunity created by potential approval of <unk> is the first prescription treatment for one of the most common diseases diagnosed in adult outpatient medicine we.
We successfully met or beat the financial expectations, we set for 2023, including the last four consecutive quarters of revenue achievement aggressive operating expense reduction targets and improvement in our average net revenue per prescription while preparing our organization. If we receive approval to launch <unk> as a treatment for chronic sinusitis.
Ramy A. Mahmoud: If we receive approval to launch Exhance as a treatment for chronic sinusitis, also called chronic rhinosinusitis without nasal discharge. Second, I'd like to reiterate the significance of the opportunity in front of us, which we believe has the potential to reshape our 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 healthcare providers at least 10 times more frequently than nasal polyps.
<unk> also called chronic rhinosinusitis without nasal polyps.
Second I'd like to reiterate the significance of the opportunity in front of us, which we believe has potential to reshape our business in the last three quarters of 2024 and for years into the future.
Claims data suggests the chronic sinusitis is currently being diagnosed by health care providers at least 10 times more frequently than nasal polyps.
Ramy A. Mahmoud: Third, I'd like to remind you that our supplemental new drug application for the new indication for exams is far along in the FDA review window. We're rapidly approaching the FDA's target action date, which is set for the end of next week. And last, if the SNDA is approved, we believe the new launch opportunity can enable us to build a profitable ENT and allergy-focused business by accessing greatly expanded net revenue potential through an existing, efficient base of commercial capabilities. In addition to that, we expect approval of the greatly expanded new indication, which will facilitate commercial partnerships in primary care and other approaches to accessing incremental value in the large physician segments beyond the universe we currently access on our own in the specialty segment where we're currently deployed.
Third I'd like to remind you that our supplemental new drug application for the new indication for <unk> is far along in the FDA review window, we're rapidly approaching the FDA target action date, which is set for the end of next week.
And last if the NDA is approved we believe the new launch opportunity can enable us to build a profitable emt and allergy focused business by accessing greatly expanded net revenue potential through an existing efficient base of commercial capabilities. In addition to that we expect approval of the greatly expanded new indication, which.
<unk> commercial partnerships in primary care and other approaches to accessing incremental value in the large physician segments beyond the universe. We currently access on our own in the specialty segment, where we're currently deployed.
Ramy A. Mahmoud: Turning to slide four, we believe future approval of EXANSE as the first and only FDA-approved treatment for chronic sinusitis has potential to increase the number of patients for whom the product can be promoted by at least tenfold because medical claims data indicate that an order of magnitude more patients are currently being diagnosed with chronic sinusitis than are being diagnosed with nasal polyps. Given published prevalence rates relative to the rate of reported claims, we do believe that nasal polyps could be diagnosed more frequently than they are being diagnosed today.
Turning to slide four.
We believe future approval of <unk> as the first and only FDA approved treatment for chronic sinusitis has potential to increase the number of patients for whom the product can be promoted by at least 10 fold because medical claims data indicate that an order of magnitude more patients are currently being diagnosed with chronic sinusitis and are being diagnosed with nasal polyps.
<unk>.
Given published prevalence rates relative to the rate of reported claims we do believe that nasal polyps could be diagnosed more frequently than it has been diagnosed today.
Ramy A. Mahmoud: However, the rate of diagnosis of nasal polyps may not be a concern if EXANSE is approved for chronic sinusitis, which is already being frequently diagnosed in the office by a broad range of physicians who do not perform the nasal endoscopic procedures that are often used to confirm the presence of nasal polyps. The new indication would create opportunity for strong growth within our existing commercial footprint, promoting it largely to ENT and allergy specialists who see a large number of patients with chronic sinusitis. The newly expanded universe of patients would also include patients cared for by physicians outside our current commercial reach. And with the new approval in hand, we will continue to actively explore commercial partnerships, alternative selling models, and other ways to facilitate future outreach to those physicians and patients. Turning to slide six. Previously, we announced that the FDA accepted our supplemental new drug application in pursuit of an enhanced indication for treatment of patients with chronic rhinosinusitis. This is a novel indication for which the agency has never previously approved any drug product.
However, the rate of diagnosis of nasal polyps may not be a concern if <unk> is approved for chronic sinusitis, which is already being frequently diagnosed in office by a broad range of physicians, who do not perform the nasal endoscopic procedures that are often used to confirm the presence of nasal polyps.
The new indication would create opportunity for strong growth within our existing commercial footprint promoting largely to emt and allergy specialists, who see a large number of patients with chronic sinusitis.
Our newly expanded universe of patients would also include patients cared for by physicians outside our current commercial reach and with the new approval in hand, we would continue to actively explore commercial partnerships alternatives selling models and other ways to facilitate future outreach to those physicians and patients.
Turning to slide six.
Previously, we announced that the FDA accepted our supplemental new drug application in pursuit of an <unk> indication for treatment of patients with chronic rhinosinusitis.
This is a novel indication for which the agency has never previously approved any drug product.
Ramy A. Mahmoud: The FDA action goal date is March 16, 2024, next week, on Saturday. In January, we announced the publication of peer review results from the RE-OPEN program in the Journal of Allergy and Clinical Immunology in Practice. We invite this audience to review the complete results via the link in today's presentation. But I will share a pair of important points that were noted in the peer review publication. First, it is the first non-surgical treatment shown to improve symptoms and sinus opacification and reduce acute exacerbations for patients with chronic rhinosinusitis with or without nasal polyps, including patients with CRS who report that their symptoms persist with the use of standard delivery nasal steroids. Second, EXAMPTH is an appropriate first-line treatment for CRS, including when symptoms persist with over-the-counter medications before escalation to surgery or systemic therapy.
The FDA action goal date is March 16th 2024 next week Saturday.
In January we announced the publication of peer reviewed results from the reopened program in the journal of allergy and clinical immunology in practice, we invite this audience to review the complete results via the link in todays presentation, but I will share a pair of important points that were noted in the peer review publication.
First <unk> is the first non surgical treatment shown to improve symptoms and scientists opacification and reduce acute exacerbations for patients with chronic rhinosinusitis with or without nasal polyps, including patients with Crs, who report that their symptoms persist with use of standard delivery nasal steroids.
And second example is an appropriate first line treatment for Crs, including when symptoms persist with over the counter medications before escalation to surgery or systemic therapy.
Ramy A. Mahmoud: Turning to slide 8. As a reminder, our objective in 2023 was to stabilize demand trends in our current nasal polyps specialty business with a reduced commercial footprint and to materially reduce expenses while both preserving the necessary launch capabilities and improving our operational efficiency and effectiveness, particularly for our commercial resources. Our efforts in the first half of 2023 drove stronger than expected demand and created an opportunity for us to further increase the efficiency of our business in the second half of 2023. We completed various analyses that enabled January 2024 optimization of our Salesforce alignment, and we thoroughly re-evaluated our distribution strategy, again allowing optimization actions in January of 2024, both aimed at best supporting the pursuit of the new chronic sinusitis opportunity.
Turning to slide eight.
As a reminder, our objective in 2023 was to stabilize demand trends and our current nasal polyps specialty business with our reduced commercial footprint and to materially reduce expenses, while both preserving the necessary launch capabilities and.
And improving our operational efficiency and effectiveness, particularly for our commercial resources.
Our efforts in the first half of 2023 drove stronger than expected demand and created an opportunity for us to further increase the efficiency of our business in the second half of 2023.
We completed various analyses that enabled January 2020 for optimization of our sales force alignment and we thoroughly reevaluated our distribution strategy again, allowing optimization actions in January of 2024, both aimed at best supporting pursuit of the new clinics aren't you cited as an opportunity.
Ramy A. Mahmoud: We also made important adjustments to our copay assistance program with the intent of reducing both the number and the proportion of prescriptions being filled that were unprofitable for our business. We believe these changes had the intended effect, as evidenced by our fourth-quarter results, in which we produced relatively stable revenues with fewer overall prescriptions at a substantially greater average net revenue per prescription than in the prior year period. Turning to slide nine.
We also made important adjustments to our co pay assistance program with the intent of reducing both the number and the proportion of prescriptions being filled that were unprofitable for our business.
We believe these changes had the intended effect as evidenced by our fourth quarter results in which we produced relatively stable revenues with fewer overall prescriptions at a substantially greater average net revenue per prescription than in the prior year period.
Turning to slide nine.
Ramy A. Mahmoud: With the 2023 objectives in mind, we are pleased by Exant's prescription demand results in the fourth quarter of 2023. There were approximately 26,500 new prescriptions filled for Exantz and 79,500 total prescriptions filled, both of which are a decrease compared to the total numbers in the fourth quarter of 2022. This is consistent with our emphasis on decreasing unprofitable prescriptions while focusing on profitable prescriptions, and it has driven a significant improvement in the average net revenue per prescription. Turning to slide 10.
With the 2023 objectives in mind, we are pleased by <unk> prescription demand results in the fourth quarter of 2023.
There were approximately 26500, new prescriptions filled for <unk> and 79500 total prescriptions filled both of which are a decrease compared to the total numbers in the fourth quarter of 2022.
This is consistent with our emphasis on decreasing unprofitable prescriptions, while focusing on profitable prescriptions and it has driven significant improvement in the average net revenue per prescription.
Turning to slide 10.
Jonathan Neely: As discussed previously, in 2023, we were successful in stabilizing demand trends in our current nasal polyps specialty business with a reduced commercial footprint and materially reduced expenses. There were approximately 115,000 new prescriptions for Exhans and 339,000 total prescriptions, both of which are low single-digit percentage decreases compared to full year 2022. Again, these numbers are influenced by intentional actions that we took to reduce the number of unprofitable prescriptions in the second half of the year and particularly in the fourth quarter, and are consistent with the fact that we observed improvement in average net revenue per prescription. I'd like to note that all the data on this slide and the prior slide are estimated based in part on monthly prescription and inventory data from third parties, but also on data directly reported to us by pharmacies that are I'll also note that the fourth quarter 2022 data that we're showing today reflects our current 2023 methodology, and for reference, we footnoted prior estimates based on the prior methodology. I'll now turn the call back over to Jonathan to discuss our fourth quarter financial performance. Thank you, Ramy. Turning to slide 12.
As discussed previously in 2023, we were successful in stabilizing demand trends in our current nasal polyps specialty business with a reduced commercial footprint and materially reduced expenses.
There were approximately 115000, new prescriptions for <unk> and 339000 total prescriptions, both of which are low single digit percentage decrease as compared to full year 2022.
Again. These numbers are influenced by intentional actions that we took to reduce the number of unprofitable prescriptions in the second half of the year and particularly in the fourth quarter and are consistent with the fact that we observed improvement in average net revenue per prescription.
I'd like to note that all the data on this slide and the prior slide are estimated based in part on monthly prescription and inventory data from third parties, but also on data directly reported to us by pharmacies that are part of the <unk> preferred pharmacy network.
I'll also note that the fourth quarter of 2022 data that we're showing today reflect our current 2023 methodology and for reference we footnoted prior estimates based on the prior methodology.
I'll now turn the call back over to Jonathan to discuss our fourth quarter financial performance.
Thank you Rami turning to slide 12.
Jonathan Neely: We are encouraged by our fourth-quarter 2023 financial results. They're shaped by our strategy to prioritize capital resources for the potential launch of exams as the first ever FDA-approved drug treatment for chronic sinusitis in 2020. As we reported earlier, OptiNose recognized $20.2 million of SG&A plus R&D expenses in the fourth quarter of 2023.
We are encouraged by our fourth quarter of 2023 financial results. They are shaped by our strategy to prioritize capital resources for the potential launch of <unk>. The first ever FDA approved drug treatment for chronic sinusitis in 2024.
As I reported earlier.
Optimists recognized $22 million of SG&A, plus R&D expenses in the fourth quarter of 2023.
Jonathan Neely: This is approximately a $6 million, or 23% decrease compared to fourth quarter 2022 expenses of $26.2 million. Regarding revenue, OptiNose recognized $19.9 million of net revenue in the fourth quarter of 2023, a 5% decrease compared to fourth quarter 2022 net revenues of $20.9 million. As Ramy referred to earlier, strength in demand has afforded us the opportunity to make gradual changes that we intend to have a positive influence on profitability now and onward into the future. As an example, in the third and fourth quarters, we revised our copay assistance program in a way that exchanged some of the first half 2023 demand strength within the uncovered and covered high-deductible commercial patient segments for increased profitability. Based on available prescription and inventory data purchased from third parties and on data we received directly from our Preferred Pharmacy Network, the estimated exchange net revenue per prescription for the fourth quarter of 2023 was $250, an 11% increase compared to $226 of estimated average net revenue per prescription in the fourth quarter of 2022. Turning to slide 13.
<unk> 6 million or 23% decrease compared to fourth quarter 2000 to 2008, two expenses of $26 2 million.
Regarding revenue Optimists recognized $19 $9 million of exams net revenue in the fourth quarter of 2023, 5% decrease compared to fourth quarter 2022, net revenues of $20 9 million.
As Rami referred to earlier strengthened demand has afforded us the opportunity to make gradual changes that we intended to have a positive influence on profitability now and onward into the future.
As an example in third and fourth quarter are we revised our copay assistance program in a way that exchange some of the first half of 2023 demand strength within the uncovered and covered high deductible commercial patient segments for increased profitability.
Based on available prescription and inventory data purchased from third parties and on data we received directly from our preferred pharmacy network. The estimated net revenue per prescription for the fourth quarter of 2023 was $250, an 11% increase compared to 2020 226 of estimated average net revenue per prescription in the fourth quarter of 2002.
'twenty two.
Jonathan Neely: Overall, our results for the full year were aligned with our intent to reduce the use of cash. We reduced operating expenses by $38 million, or 31%, for the full year of 2023 when compared to the full year of 2022, of which approximately 28 million was driven by changes we made within SG&A. We outperformed our expectations for full year 2023, Expanse Net Revenue and Average Expanse Net Revenue per Prescription with $71 million and $209 per script, respectively. And we achieved this while sustaining stable product demand and maintaining the capabilities and resources that we believe will be necessary to enable a successful launch of a potential new indication for Exantus in 2024. On a final note on results, we reported a cash position of $73.7 million as of December 31, 2023. Turning to slide 15.
Turning to slide 13 overall, our results for the full year were aligned with our intent to reduce use of cash we reduced operating expenses by $38 million or 31% for the full year of 2023, when compared to full year 2022.
Of which approximately $28 million was driven by changes we made within SG&A.
We outperformed our expectations for full year 2023 exams that revenue average net revenue per prescription was $71 million and $209 per script, respectively.
And we achieved this while sustaining stable product demand and maintaining the capabilities and resources that we believe will be necessary to enable a successful launch of a potential new indication for <unk> in 2024.
On a final note on results, we reported a cash position of $73 7 million as of December 31, 2023.
Turning to slide 15 today, we announced initial guidance for first quarter of 2024, <unk> net revenues for full year 2024, <unk> net revenue per prescription.
Jonathan Neely: Today we announced financial guidance for first quarter 2024 Exantus Net Revenues and for full year 2024 Exantus Net Revenue per prescription. We are prepared to launch the new indication for Expansion if approved, and believe there is an expanded revenue opportunity we can access immediately with our existing commercial capability. In addition, there are opportunities outside our footprint where we can create value through commercial partners.
We are prepared to launch the new indication for <unk>, if approved and believe there is an expanded revenue opportunity. We can access immediately with our existing commercial capabilities.
In addition, there are opportunities outside our footprint, where we can create value through commercial partnerships.
While we are excited by the potential for near term <unk> approval, we will reserve comment regarding the specific details of our full year revenue and operating expense expectations for now.
That said, we expect first quarter 2024, net revenues to be approximately $13 million, an increase of approximately 10% compared to first quarter 2022 talking 'twenty three that reflects our operating strategy focused on increased efficiency a stabilization of revenues, while preparing for potential launch of <unk>.
Jonathan Neely: While we are excited by the potential for near-term CS approval, we will reserve comment regarding the specific details of our full-year revenue and operating expense expectations for now. That said, we expect first quarter 2024 enhanced net revenues to be approximately $13 million, an increase of approximately 10% compared to first quarter 2022-2023 that reflects our operating strategy focused on increased efficiency and stabilization of revenue. While preparing for the potential launch of Xans, the first and only approved treatment for CRS patients who do not have nasal polyps, we anticipate average Exans Net Revenues per prescription will be approximately $220 for the full year of 2024.
Only approved treatment for Crs patients, who do not have nasal polyps.
In addition, we anticipate average <unk> net revenue per prescription will be approximately $220 for the full year of 2024.
A 5% increase compared to 2023 that is supported by the changes to the co pay assistance that I just discussed I will now turn the call back over to Rami for closing remarks Rami.
Thank you Jonathan.
We moved to take questions I'd like to reiterate the significance of the opportunity in front of us, which we believe has potential to reshape our business starting in the second quarter of this year and for years into the future where.
We're pleased with our success in executing against the 2023 operating strategy and with having achieved greatly increased operating efficiency, while stabilizing revenue in the current comparatively niche indication, while we preserved capital and focused our organization on preparations to seize the opportunity that could be created by approval of <unk> as the first prescription treatment for one of them.
Ramy A. Mahmoud: There is a 5% increase compared to 2023 that is supported by the changes to copay assistance that I just discussed. I will now turn the call back over to Ramy for closing remarks. Thank you, Jonathan.
Common diseases in adult outpatient medicine.
We believe the new launch opportunity can enable us to build a profitable emt and allergy focused business by accessing greatly expanded net revenue potential through inefficient existing base of commercial capabilities.
Ramy A. Mahmoud: Before we move to take 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're pleased with our success in executing against the 2023 operating strategy and with having achieved greatly increased operating efficiency while stabilizing revenue in the current comparatively niche indication. While we preserved capital and focused our organization on preparations to seize the opportunity that could be created by approval of Exhance as the first prescription treatment for one of the most common diseases in adult outpatient medicine.
In addition, we believe an approval on the expanded indication will facilitate commercial partnerships in primary care and other approaches to accessing the incremental value in the space beyond what we can access on our own in the specialty segment.
With that I'd like to thank you for your attention and open the call for Q&A.
Thank you.
As a reminder to ask a question you will need to press star one on your telephone.
Your question. Please press Star one again, please wait for your name to be announced please standby, while we compile the Q&A roster one moment for your first question. Please.
Unknown Executive: We believe the new launch opportunity can enable us to build a profitable E&T and allergy-focused business by accessing greatly expanded net revenue potential through an efficient existing base of commercial capability. In addition, we believe approval and the expanded indication will facilitate commercial partnerships in primary care and other approaches to accessing the incremental value in the space beyond what we can access on our own in the specialty segment. With that, I'd like to thank you for your attention and open the call for Q&A. Thank you. As a reminder, to ask a question, you'll need to press star 11 on your telephone. To withdraw your question, please press star 11 again.
Our first question comes from the line of Thomas Flaten with Lake Street Capital markets. Your line is now open.
Hey, good morning, guys. Congrats on an excellent quarter two questions for me Rami could you provide a little bit more detail on the sales force and distribution optimization that you did in January.
Yes, I'll give a little more information we can.
Currently have 75 sales territories in the.
The realignment in our sales force that I was talking about was to specifically align our deployment of salesforce against the chronic sinusitis opportunity as opposed to our historical deployment, which was aligned against the nasal polyps opportunity.
Unknown Executive: Please wait for your name to be announced. Please stand by while we compile the Q&A roster. One moment for our first question, please. Our first question comes from the line of Thomas Flaten with Lake Street Capital Markets. Your line is now open. Hey, good morning, guys. Congratulations on an excellent quarter. Two questions for me.
Great.
And then with respect to your conversations with FDA.
I don't know if you guys made it very hard label negotiations last time around but could you maybe comment on how that's been going and whether or not the efficacy or the <unk>.
Ramy A. Mahmoud: Ramy, could you provide a little bit more detail on the Salesforce and distribution optimization that you did in January? Yeah, I'll give you a little more information. We currently have 75 sales territories, and the realignment in our sales force that I was talking about was to specifically align our deployment of the sales force against the chronic sinusitis opportunity as opposed to our historical deployment, which was aligned against the nasal polyps opportunity. Ramy Mahmoud, Brandon Folkes, Jonathan Neely, Paul Spence, Thomas Flaten, Schuyler Broek, OptiNose, Tom, I' And what I can say is that we have exchanged communication with FDA around the content of the label, as you would expect, as a normal place we are in the review process. And based on the clinical trial data that we've submitted for their review, we continue to have confidence that we have a solid package and that we can bring real value to patients with high unmet need. Great. I appreciate you taking the time to answer the questions. I'll get back to you.
Data they requested.
Well it will have any impact on how you think your label as written.
Tom I'm sure you can appreciate that I can't comment on Fda's thinking sort of not in a position to do that.
And what I can say is that.
We have we have exchange communication with FDA around the content of the label as you would expect in a normal normal place we are in the review process.
And based on the clinical trial data that we've submitted for their review we continue to have confidence that that we have a solid package.
And that we can bring real value to patients with high unmet need.
Great I appreciate you taking the questions I'll get back in queue. Thank you.
Thank you one moment for our next question. Please.
Our next question comes from the line of David <unk> with Piper Sandler Your line is now open.
Unknown Executive: Thank you. Thank you. One moment for our next question, please. Our next question comes from the line of David Amselin with Piper Sandler. Your line is now open.
So I appreciate youre not providing.
Ramy A. Mahmoud: Thanks. So I appreciate you're not providing full-year guidance, but maybe I can sort of dig into the opportunity a little differently, which is, with the existing infrastructure, the commercial infrastructure that you have in place, can you talk about what portion of the opportunity you think you can access in terms of non-polyp patients and to the extent you can size that opportunity either in terms of volumes or in terms of sales, again with the existing infrastructure you have in place. Thanks. Sure, David.
In your guidance, but maybe I'll dig.
Dig into the opportunity a little differently, which is with the existing infrastructure commercial infrastructure that you have in place can you talk about what portion of the opportunity.
Thank you can access in terms of.
Non polyp patients.
And to the extent you can.
Size that opportunity.
Either in terms of volume or in terms of sales again with the existing infrastructure.
Thanks.
Sure David So.
Ramy A. Mahmoud: So, I think you saw from our earlier slides that we believe that the total addressable market here of activated patients is on the order of 10 to 12 million. We estimate that approximately one-third of that population is cared for in the specialty universe. So that would mostly be ENT and allergy specialists where we are currently deployed. Our 75 territories, the realignment in January, are optimized against the chronic sinusitis opportunity, and we expect to reach a meaningful fraction of the physicians who are the highest prescribing in that specialty space. So we think we have access to a large part of that segment. Is that addressing the question you asked, David?
I think I think you saw from our earlier slides, we believe that the total accessible the total addressable market here of activated patients is on the order of $10 million to $12 million.
We estimate that approximately one third of that population is cared for in the specialty universe. So that would be mostly E&P and allergy specialists, where we are currently deployed.
Our 75 territories.
The realignment in January.
Our optimized against the chronic sinusitis opportunity and we expect to reach a meaningful fraction of the physicians who are the highest prescribing.
That specialty space. So we think we have we have access to a large part of that segment.
Is that is that addressing the question you asked David.
Ramy A. Mahmoud: Yeah, that's helpful. And then maybe as a follow-up to that, I know that payer dynamics are particularly important. Can you talk about the nature of the dialogue you've had with payers and your level of confidence that access would be markedly improved to the extent you do get the label expansion? Yeah, I'll make a couple of comments about that, and thank you for the question. So the first thing I'll say is that, you know, just like I can't speak for FDA, I can't speak for payers. And the payer environment is challenging, I think, for everyone selling a branded product today.
Yes, that's helpful and then maybe.
As a follow up to that I know that.
Payer dynamics are particularly important and you talk to.
The nature of the dialogue, you've had with payers and your level of confidence that access would be markedly improved to the extent you do get the label expansion.
Yes, I'll make a couple of comments about that and thank you for the question.
So the first thing I'll say is that.
Just like I can't speak for <unk> I can't speak for payers in the payer environment is challenging I think for everyone selling a branded product today.
Ramy A. Mahmoud: Having said that, our current contracts, by and large, and we have been transparent with payers about the pending nature of our application for chronic sinusitis and the timing. The current contracts that we have, by and large, where they call for utilization management, call for utilization management that restricts to FDA-approved indications, as opposed to restriction to the diagnosis of nasal polyps. So we think under those contracts, the addition of chronic sinusitis as an FDA-approved indication will fall within the scope of existing contracts. Having said that, we also think it's very important that a much broader range of physicians, including those who are not able to do nasal endoscopy in the office, will be able to and comfortable in making the diagnosis of chronic sinusitis in a much broader range and with more frequency than we're comfortable making the diagnosis of nasal polyps.
Having said that our current contracts by and large and we have been transparent with payers about the.
How about the pending nature of our application for chronic sinusitis in the timing.
The current contracts that we have.
By and large.
They call for utilization management.
Call for utilization management that restricted to FDA approved indication as opposed to restriction to the diagnosis of nasal polyps.
So we think under those contracts.
The addition of chronic sinusitis is an FDA approved indication will fall within the scope of existing contracts.
Having said that we also think it's very important that a much broader range of physicians, including those who are not able to do nasal endoscopy in office.
We will be able to and comfortable in making the diagnosis of chronic sinusitis, a much broader range and with more frequency than we're comfortable making the diagnosis of nasal polyps.
Unknown Executive: Okay, that's helpful. Thank you. Thank you. As a reminder, to ask a question, that's star 11.
Okay. That's helpful. Thank you.
Thank you as a reminder to ask a question Thats Star one one.
Ramy A. Mahmoud: And this concludes our Q&A portion. I'll turn the call back to Dr. Ramy Mahmoud for a closing remark. I'd like to thank you all for joining us this morning. We're very pleased with the results of 2023, but even more so, we're excited about the prospects for 2024. We're looking forward to hearing from FDA on their target action date, and should that be an approval, we're looking forward to an aggressive launch of the product into the marketplace starting in the second quarter. We believe there are a large number of patients whose suffering can be alleviated by this product, and we think that can be a solid base for growing the company, both in the chronic sinusitis space and looking farther forward into the future with other ENT and allergy products that are synergistic with the product we're selling today.
And this concludes our Q&A portion and I will turn the call back to Dr. Rami Mahmud for closing remarks.
I'd like to thank you all for joining us. This morning, we're very pleased with the results of 2023, but even more so we're excited about the prospects for 2024, and we're looking forward to hearing from FDA on their target action date and should that be an approval. We're looking forward to sort of launch of the product into the marketplace.
In the second quarter. We believe there is a large number of patients who are suffering can be alleviated by this product and we think that can be a solid base for growing the company both in the chronic sinusitis space and looking further forward into the future.
With other E&P and allergy products that are there.
Unknown Executive: So again, thank you for joining us this morning. This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone have a wonderful day. Transcribed by https://otter.ai, Thomas Folkes, Unknown Executive, Jonathan Neely, Paul Spence, Thomas Flaten, Schuyler Broek, OptiNose Inc. www.opti-nose.com
So synergistic with some with the product we're selling today. So again, thank you for joining this morning.
This concludes today's conference call. Thank you for your participation you may now disconnect everyone have a wonderful day.
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Thank you.
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