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| Statement |
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| With the 2023 objectives in mind, we are pleased by XHANCE prescription demand results in the fourth quarter of 2023 |
| 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 |
| 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 XHANCE as a treatment for chronic sinusitis, also called chronic rhinosinusitis without nasal polyps |
| 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 |
| 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 |
| As Ramy 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 |
| We’re very pleased with the results of 2023, but even more so, we’re excited about the prospects for 2024 |
| 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 efficient existing base of commercial capabilities |
| We believe there’s 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 further forward into the future with other ENT and allergy products that are synergistic with the product we’re selling today |
| 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 |
| 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 |
| 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 XHANCE as the first prescription treatment for one of the most common diseases in adult outpatient medicine |
| As an example, in third and fourth quarter, we revised our co-pay 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 |
| 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 |
| 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 XHANCE in 2024 |
| The new indication would create opportunity for strong growth within our existing commercial footprint, promoting largely to ENT and allergy specialists who see a large number of patients with chronic sinusitis |
| Congrats on an excellent quarter |
| That strategy was to greatly increase our operating efficiency and to stabilize XHANCE revenue while preparing our organization to seize the greatly expanded opportunity created by potential approval of XHANCE as the first prescription treatment for one of the most common diseases diagnosed in adult outpatient medicine |
| We outperformed our expectations for full year 2023 |
| We're prepared to launch the new indication for XHANCE if approved, and believe there is an expanded revenue opportunity we can access immediately with our existing commercial capabilities |
| We are encouraged by our fourth quarter 2023 financial results |
| 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 |
| We believe these changes have the intent effect, as evidenced by our fourth quarter results in which we produce relatively stable revenues with fewer overall prescriptions at a substantially greater average net revenue per prescription than in the prior year period |
| Based on available prescription and inventory data purchased from third parties and on data we received directly from our preferred pharmacy network, the estimated XHANCE 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 |
| In addition, there are opportunities outside our footprint where we can create value through commercial partnerships |
| That said, we expect first quarter 2024 XHANCE 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 revenues while preparing for a potential launch of XHANCE as first and only approved treatment for CRS patients who do not have nasal polyps |
| First, I'd like to commend our team for successfully executing our 2023 operating strategy |
| 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 |
| We believe future approval of XHANCE 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 ten-fold because medical claims data indicate that in order of magnitude, more patients are currently being diagnosed with chronic sinusitis than are being diagnosed 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 |
| Statement |
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| And the payer environment is challenging, I think, for everyone selling a branded product today |
| Regarding revenue, OptiNose recognized $19.9 million of XHANCE net revenue in the fourth quarter of 2023, a 5% decrease compared to fourth quarter 2022 net revenues of $20.9 million |
| There were approximately 26,500 new prescriptions filled for XHANCE and 79,500 total prescriptions filled, both of which are a decrease compared to the total numbers in the fourth quarter of 2022 |
| There were approximately 115,000 new prescriptions for XHANCE and 339,000 total prescriptions, both of which are low single-digit percentage decreases compared to full year 2022 |
| So I appreciate you're not providing full year guidance |
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