In its Q3 2023 earnings call, OptiNose reported stable financial performance and emphasized the potential of its new indication for XHANCE as a treatment for chronic sinusitis. The supplemental new drug application is currently under FDA review, with a decision expected by December 2023. The company also outlined its strategies for commercialization, including exploring partnerships in primary care and leveraging direct-to-consumer outreach and telemedicine.
Key takeaways from the call include:
- OptiNose's new indication for XHANCE could significantly expand its market and revenue potential. The drug is currently under FDA review, with a decision expected in December 2023.
- The company reported a 1% decrease in net revenue compared to the previous year, but expects XHANCE net revenue for the full year of 2023 to be between $66 million and $70 million.
- OptiNose is exploring commercial partnerships in primary care and other approaches to access incremental value beyond its current specialty segment.
- The company is also considering direct-to-consumer outreach and telemedicine as alternative commercialization strategies.
- OptiNose anticipates no significant change in the pricing of XHANCE upon approval for the new indication.
During the call, Dr. Ramy Mahmoud, a representative of the company, highlighted the potential of XHANCE to reshape OptiNose's business in the coming months and years. The company is executing its 2023 operating strategy to increase efficiency and stabilize revenue, with the goal of building a profitable ENT and allergy focused business.
Dr. Mahmoud also discussed the company's exploration of commercial partnerships in primary care and other strategies for accessing additional value. The FDA review for XHANCE is progressing, and label negotiations have not yet started. The company expects to reach a revenue per prescription of around $200 for the full year.
In case of any setback with the label expansion, the company will consider different strategic options. However, the pricing of the product is not expected to change significantly upon approval. With a focus on stabilizing revenue at lower costs, OptiNose is well-positioned to launch into a new indication next year.
InvestingPro Insights
In light of the recent earnings call, it's worth considering some InvestingPro metrics and tips for OptiNose. According to InvestingPro, OptiNose has been experiencing a decline in revenue at an accelerating rate. This aligns with the 1% decrease in net revenue reported in the earnings call.
InvestingPro also notes that OptiNose's stock price often moves in the opposite direction of the market, which could be a significant factor for investors considering the potential of XHANCE and the company's new commercialization strategies.
Finally, InvestingPro points out that OptiNose has not been profitable over the last twelve months. This underlines the importance of the company's ongoing efforts to increase efficiency and stabilize revenue.
InvestingPro has an array of other tips and metrics available for OptiNose and a host of other companies. It's a valuable resource for anyone looking to make informed investment decisions.
Full transcript - OPTN Q3 2023:
Operator: Good day and thank you for standing by. Welcome to OptiNose Third Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Jonathan Neely, Vice President, Investor Relations and Business Development. Please go ahead, sir.
Jonathan Neely: Good morning. And thanks for joining us today as we review OptiNose’s third quarter 2023 performance and our plans for remainder of the year. 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 Investors section. Before we start, I would like to remind you that our discussions during this conference call will include forward-looking statements. All statements that are not historical facts are hereby identified as forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated by such statements. Additional information regarding these factors and forward-looking statements is discussed under 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-Qs that are filed with the SEC and available at their website, sec.gov, and on our website at optinose.com. You are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements during this conference call speak only as of the original date of this call or any earlier date indicated in such statement and we undertake no obligation to update or revise any of these statements. We will now make prepared remarks and then we will move to a question-and-answer session. With that, I will now turn the call over to Ramy.
Dr. Ramy Mahmoud: Thank you, Jonathan, and thank you to everyone listening for joining us this morning. We appreciate you joining us for our third quarter update. Starting on slide three, 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 potential to reshape our business in the coming months and for years into the future. Claims data suggest that CS is currently being diagnosed by healthcare providers at least 10 times more frequently than nasal polyps. Second, I’d like to remind you that our supplemental new drug application for the new indication for XHANCE is far along in the FDA review window. We submitted our application in February and are rapidly approaching the FDA target action date in December. And last, our results demonstrate that we have continued to successfully execute on our 2023 operating strategy. That strategy has been to greatly increase our operating efficiency and to stabilize revenue in the current comparatively niche indication, while preparing our organization to seize the opportunity created by the potential approval of XHANCE as the first prescription treatment for one of the most common diseases diagnosed in adult outpatient medicine. 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. In addition, as I previously noted, we continue to actively explore commercial partnerships in primary care and other approaches to accessing the incremental value beyond what we can create on our own in the largely Specialty segment where we’re currently deployed. Turning to slide four, we believe future approval of XHANCE as the first and only FDA approved treatment for CS 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. We believe that nasal polyps is also underdiagnosed relative to the published prevalence in part because it can be difficult to visualize the part of the nasal labyrinth where polyps emerge in offices that do not have the ability to perform nasal endoscopy. This further accentuates the potential associated with a new indication that is more amenable to office diagnosis by a broad range of physicians. The new indication would create opportunity for strong growth within our existing commercial footprint, promoting largely to specialists who see large numbers of patients with the diagnosis. And the newly expanded universe of patients would also include patients cared for by physicians outside of our current commercial reach and we are actively exploring 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 XHANCE indication for the treatment of patients with chronic rhinosinusitis. This is a novel indication for which the agency has never previously approved any drug product. Our regulatory and clinical teams have focused on being responsive to the FDA during the review, and they will continue to do so through the remaining weeks of the review process. The FDA action goal date is December 16th of this year. Turning to slide eight. As a reminder, our objective in 2023 has been to stabilize demand trends in our current nasal polyps’ specialty business with a reduced commercial footprint and materially reduced expense, while both preserving necessary launch capabilities and improving operational efficiency and effectiveness of our commercial resources. This is intended to best set us up for successful launch of XHANCE into the new chronic sinusitis space in 2024. With that objective in mind, we are very pleased by XHANCE prescription demand results in the third quarter of 2023. As we discussed in our last call, overall prescription demand in the first half of the year for XHANCE was stronger than we initially anticipated. This has created the opportunity for us to take thoughtful action to attempt to reduce both the number and proportion of unprofitable prescriptions. We are seeing early evidence in our prescription data that our actions have begun to produce the intended outcome, which is also resulting in an improvement in the average net revenue per prescription. Regarding prescription demand, in the third quarter of 2023, there were approximately 27,400 new prescriptions for XHANCE, a decrease of 4% compared to the third quarter of 2022. In addition, there were approximately 84,100 total prescriptions for XHANCE in the third quarter of 2023, a decrease of 6% compared to the third quarter of 2022. We measure breadth and depth of physician prescribing by estimation of the total number of physicians who have patients filling various numbers of XHANCE prescriptions. Regarding breadth, in the third quarter of 2023, there were approximately 8,400 physicians who had a patient fill at least one prescription of XHANCE, an increase of 5% compared to the third quarter of 2022. Regarding depth, the number of physicians who had more than 15 XHANCE prescriptions filled by their patients in the quarter decreased from 1,485 in the third quarter of 2022 to 1,346 in the third quarter of 2023. I’d like to note that all the data on this slide is estimated based in part on monthly prescription and inventory data from third parties and on data directly reported to us by pharmacies that are part of the XHANCE preferred pharmacy network. I will also note that the third quarter 2022 data we’re showing today reflects our current 2023 methodology. For reference, we footnoted our prior estimates based on prior methodology. I’ll now turn the call back over to Jonathan to discuss third quarter financial performance.
Jonathan Neely: Thank you, Ramy. Turning to slide 10, we are encouraged by our third quarter 2023 financial results. They are shaped by our strategy to prioritize capital resources for the potential launch of XHANCE as the first ever FDA approved drug treatment for chronic sinusitis. As we reported earlier, OptiNose recognized $19.3 million of SG&A plus R&D expenses in the third quarter of 2023. This is approximately a $9 million, a 33% decrease compared to third quarter 2022 expenses of $28.8 million. Regarding revenue, OptiNose recognized $19.8 million of XHANCE net revenue in the third quarter of 2023, a 1% decrease, compared to third quarter 2022 net revenues of $20.1 million. As Rami referred to earlier, the strength in demand in the first half has afforded us the opportunity to make gradual changes that we intend to have a positive influence on profitability now and in the future. As an example, in third quarter and fourth quarter, we revised our co-pay assistance program in a way that we expect will result in exchanging some of the first half 2023 demand strength within the uncovered commercial patient segment for increased profitability. Based on available prescription and inventory data purchased from third parties and on data that we received directly from our preferred pharmacy network, the estimated XHANCE average net revenue per prescription for the third quarter of 2023 was $236, a 6% increase compared to $223 of estimated revenue per prescription in the third quarter of 2022. Overall, our results for the first nine months of the year continue to align with our intent to reduce use of cash in 2023. We reduced operating expenses by $32 million or 33% in the first nine months of 2023 when compared to the first nine months of 2022. We have also outperformed our initial expectations for revenue and we achieved this while sustaining product demand and maintaining the capabilities and resources that we believe will be necessary to enable a successful launch of the potential new indication for XHANCE in 2024. As a final note on results, we reported a cash position of $66.8 million as of September 30, 2023, a use of $27.4 million on a year-to-date basis. Turning to slide 12, as I just mentioned, XHANCE net revenues remain stable and strong in third quarter. As a result of that performance, we have increased our revenue expectations for full year 2023 by raising the low end of the range. We now expect XHANCE net revenue for the full year of 2023 to be between $66 million and $70 million. Previously, we expected XHANCE net revenue to be between $64 million and $70 million. With respect to XHANCE average net revenue per prescription, we continue to expect our average net revenue per prescription to be approximately $200 for the full year of 2023. Finally, we continue to expect operating expenses to find a sales, general and administrative plus research and development expenses for full year 2023 to be in the range from $88 million to $93 million, of which approximately $6 million is stock-based compensation. I will now turn the call back over to Ramy for closing remarks. Ramy?
Dr. Ramy Mahmoud: Thank you, Jonathan. 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 really reshape our business in the coming couple of months and for years into the future. We have continued to successfully execute on our 2023 operating strategy, which has been to greatly increase operating efficiency and stabilize revenue, while preparing our organization to seize the 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 believe the new launch opportunity could 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. In addition, as I said before, we continue to actively explore commercial partnerships in primary care and other approaches to accessing the incremental value beyond what we can create on our own in the Specialty segment where we’re currently deployed. With that, I’d like to thank you for your attention and open up the call for Q&A.
Operator: Thank you. [Operator Instructions] One moment for our first question, please. Our first question will come from the line of Thomas Flaten with Lake Street. Your line is now open.
Thomas Flaten: Thank you. Good morning, guys. Appreciate you taking the questions. Ramy, you mentioned the FDA review was far along. I’m curious if you could confirm if you’ve started label negotiations.
Dr. Ramy Mahmoud: Thanks for the question, Tom. We are 37 days away from our target action date, which is a little before the time when we would expect label negotiations to start. So, no, they haven’t started yet, but neither have we expected them to start quite yet. They may start soon within this month.
Thomas Flaten: Great. And Jonathan, you mentioned that there was some co-pay restructuring that you were doing that might make Q4 more profitable. I’m assuming you meant on a revenue per prescription basis. You guys are averaging ahead of the $200 for the year, which would imply that you’d have a downshift to get to $200, I know you say approximately. But could you give us some more color on what you expect that sequential move in revenue per prescription to be based on the changes to co-pay, et cetera, that you mentioned?
Jonathan Neely: Yeah. First, I guess, on a year-to-date basis, there’s some additional material in the presentation today in the appendix. But just to confirm, we’re actually at $197 on a year-to-date basis. So we are still slightly below that $200 mark. But as you point out, in third quarter, we had a $236 revenue per prescription and so we think that we’re in really good shape in terms of going into the fourth quarter where, typically, the last three quarters of the year, you have better revenue per prescription than you do in the first quarter of the year and we should close out the year in our expectations somewhere around that $200 mark.
Thomas Flaten: And then the final one for me, oh…
Dr. Ramy Mahmoud: For the full year.
Jonathan Neely: For the full year. Yeah.
Thomas Flaten: Just the final one, Ramy, in your prepared comments right at the conclusion there, you said you’re continuing to explore primary care partnerships and I don’t know how you phrased it, but you said something like other approaches. I was curious if you might flesh out for us what other approaches might be aside from a primary care partnership?
Dr. Ramy Mahmoud: Well, and I’ll invite Paul to comment if he likes as well. But there are a variety of emerging promotional approaches that do not involve pure reliance on direct selling. For example, leverage of direct-to-consumer outreach and telemedicine. And we are exploring a variety of different kinds of approaches that might be applicable to our product and our audience for commercializing the product other than just the traditional direct sales model.
Thomas Flaten: Great. Appreciate you guys taking the questions. Thank you.
Operator: Thank you. One moment for our next question, please. Our next question will come from the line of David Amsellem with Piper Sandler. Your line is now open.
Unidentified Analyst: Hi. Thanks. This is Skyler [ph] on for David. First, I just have a hypothetical. If somehow the label expansion did not occur for some reason, how do you think about strategic options and how would that impact the overall company and long-term plans for expanse? And then I have a follow-up after.
Dr. Ramy Mahmoud: Hi, Skyler, and thanks for the question. So, the strategic future of the company will be significantly different if the product is not approved on December 16th. The specifics of what the company’s strategic options would be and the kind of options that would be most appropriate for us will in part be governed by the nature of the FDA response and the kinds of actions that might be required to continue to pursue the indication. So it’s a little premature for us to speak specifically about what strategic options we’d be pursuing. I can only say that we would remain open to a variety of strategies driven by whatever the circumstances are that emerge when we get the actual response letter.
Unidentified Analyst: Got it. That makes sense. And then next on the payer landscape, with the expanded label, what would you think would be the net pricing per prescription would look like? Any additional details you could give there, would be helpful? Thank you.
Dr. Ramy Mahmoud: So, it’s hard to speak with confidence about the future when a variety of actors are involved. So I can’t be certain. But our belief, as I think we’ve said before is that, we don’t think there will be any material change to the pricing of the product based purely on the approval. In other words, the price of the product and the net price of the product the day after approval will be the same as it was the day before approval.
Unidentified Analyst: Got it. Thank you.
Operator: Thank you. I’m showing no more questions at this time. I’d like to hand the conference back over to Dr. Mahmoud for closing remarks.
Dr. Ramy Mahmoud: So in conclusion, I think, we’re all very happy with how this year has gone so far. As you’ve seen illustrated through third quarter, the company has really delivered on stabilizing revenue at dramatically lower cost. We think the company is now very well positioned to be a stable foundation to efficiently launch into a new indication in next year. And in the next month or two here, we’re really looking forward to that opportunity. Thank you all again for joining this morning and we look forward to talking to you again soon.
Operator: This concludes today’s conference call. Thank you for your participation. You may now disconnect. Everyone have a wonderful day.
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