OptiNose Q4 2023 Earnings Call Transcript

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March 7, 2024

There are 5 speakers on the call.

Operator

Good day and thank you for standing by and welcome to the Optnos 4th Quarter 2023 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. 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.

Operator

Please go ahead.

Speaker 1

Good morning and thank you for joining us today as we review OptiNose's Q4 and full year 2023 performance and our plans for the year ahead. I'm joined today by our CEO, Doctor. 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.

Speaker 1

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 the cautionary note on the 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 ks that is 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 by such statement, and we undertake no obligation to update or revise any of these statements.

Speaker 1

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.

Speaker 2

Great. Thank you, Jonathan, and thank you to everyone listening for joining us this morning. We appreciate you joining for our Q4 and full year 2023 update. So starting on Slide 3, and we'll go into more detail in a moment, but I'd like to highlight 4 key takeaways from today's presentation. First, I'd like to commend our team for successfully executing our 2023 operating strategy.

Speaker 2

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 successfully met or beat the financial expectations we set for 2023, including the last 4 consecutive quarters of revenue achievement, aggressive operating expense reduction targets and the 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. 2nd, 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 that chronic sinusitis is currently being diagnosed by healthcare providers at least 10 times more frequently than nasal polyps. 3rd, 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.

Speaker 2

We're rapidly approaching the FDA 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 facilitate commercial partnerships in primary care and other approaches to accessing incremental value in the large physician segments beyond the universe 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 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 it is being diagnosed today. However, the rate of diagnosis of nasal polyps may not be a concern if XHANCE 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.

Speaker 2

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. 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 would continue to actively explore commercial partnerships, alternative selling models and other ways to facilitate future outreach to those physicians and patients. Turning to Slide 6. Previously, we announced that the FDA accepted our supplemental new drug application in pursuit of an XHANCE indication for treatment of patients with chronic rhinosinusitis.

Speaker 2

This is a novel indication for which the agency has never previously approved any drug product. The FDA action goal date is March 16, 2024, next week Saturday. In January, we announced the publication of peer review results from the REOPEN program in the Journal of Allergy and Clinical Immunology and 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, XHANCE is the 1st 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 use of standard delivery nasal steroids.

Speaker 2

And second, XHANCE is an appropriate first line treatment for CRS, including when symptoms persist with over the counter medications before escalation to surgery or systemic therapy. 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 twenty twenty three drove stronger than expected demand and created an opportunity for us to further increase the efficiency of our business in the second half of twenty twenty three. We completed various analyses that enabled January 2024 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 chronic sinusitis opportunity.

Speaker 2

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 4th 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 9. With the 2023 objectives in mind, we are pleased by XHANCE prescription demand results in the Q4 of 2023. 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 Q4 of 2022.

Speaker 2

This is consistent with our emphasis on decreasing unprofitable prescriptions, focusing on profitable prescriptions and it has driven significant improvement in the average net revenue per prescription. Turning to Slide 10. As discussed previously, in 2023, we were successful in stabilizing demand trends in our current nasal polype specialty business with a reduced commercial footprint and materially reduced expenses. 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. 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 Q4 and are consistent with the fact that we observed improvement in average net revenue per prescription.

Speaker 2

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 XHANCE preferred pharmacy network. I'll also note that the Q4 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 Q4 financial performance.

Speaker 1

Thank you, Rami. Turning to Slide 12. We are encouraged by our Q4 2023 financial results. They are shaped by our strategy to prioritize capital resources for the potential launch of XANZZA's the first ever FDA approved drug treatment for chronic sinusitis in 2024. As I reported earlier, OptiNose recognized $20,200,000 of SG and A plus R and D expenses in the Q4 of 2023.

Speaker 1

This is approximately a $6,000,000 or 23 percent decrease compared to Q4 2022 expenses of $26,200,000 Regarding revenue, OptiNose recognized $19,900,000 of XHANCE net revenue in the Q4 of 2023, a 5% decrease compared to Q4 2022 net revenues of $20,900,000 As Rami referred to earlier, strength in 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 3rd Q4, we revised our co pay assistance program in a way that exchanged some of the first half twenty twenty three demand strength within the uncovered and covered high deductible commercial patient segments for increased profitability. Based on available prescription and inventory data from third parties and on data we received directly from our preferred pharmacy network, the estimated XHANCE net revenue per prescription for the Q4 of 2023 was $2.50 an 11% increase compared to $2.26 of estimated average net revenue per prescription in the Q4 of 2022. Turning to Slide 13. Overall, our results for the full year were aligned with our intent to reduce use of cash.

Speaker 1

We reduced operating expenses by $38,000,000 or 31% for the full year of 2023 when compared to full year 2022, of which approximately $28,000,000 was driven by changes we made within SG and A. We outperformed our expectations for full year 2023. XHANCE net revenue and average XHANCE net revenue per prescription was $71,000,000 $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 XHANCE in 2024.

Speaker 3

On a final note

Speaker 1

on results, we reported a cash position of $73,700,000 as of December 31, 2023. Turning to Slide 15. Today, we announced the financial guidance for Q1 of 2024 Axance net revenues and for full year 2024 Axance net revenue XHANCE net revenue per prescription.

Speaker 2

We are prepared to launch the new indication for

Speaker 1

XHANCE 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 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 Q1 2024 XHANCE net revenues to be approximately $13,000,000 an increase of approximately 10% compared to Q1 2022 2023 that reflects our operating strategy focused on increased efficiency and stabilization of revenues, while preparing for potential launch of XHANCE, the 1st and only approved treatment for CRS patients who do not have nasal polyps. In addition, we anticipate average XHANCE net revenues per prescription will be approximately $2.20 for the full year of 2024.

Speaker 1

There's a 5% increase compared to 2023 that is supported by the changes to co pay assistance that I just discussed. I will now turn the call back over to Rami for closing remarks. Rami?

Speaker 2

Thank you, Jonathan. Before we move 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 Q2 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 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. 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, 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.

Speaker 2

With that, I'd like to thank you for your attention and open the call for Q and A.

Operator

Thank you. Our first question comes from the line of Thomas Flaten with Lake Street Capital Markets. Your line is now open.

Speaker 3

Hey, good morning guys. Congrats on an excellent quarter. Two questions from me. Rami, could you provide a little bit more detail on the sales force and distribution optimization that you did in January?

Speaker 2

Yes. I'll give 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 sales force against the chronic sinusitis opportunity as opposed to our historical deployment, which was aligned against the nasal polyps opportunity.

Speaker 3

Great. And then with respect to your conversations with FDA, I don't know if you guys made it very far in label negotiations last time around, but could you maybe comment on how that's been going and whether or not the efficacy cut or the data cut they requested will have any impact on how you think your label is written?

Speaker 2

Tom, I'm sure you can appreciate that. I can't comment on FDA's thinking. I'm sort of not in a position to do that. And what I can say is that, we have exchanged communication with FDA around the content of the label as you would expect and 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.

Speaker 3

Great. I appreciate taking the questions. I'll get back in the queue. Thank you.

Operator

Thank you. One moment for our next question, please. Our next question comes from the line of David Amsellem with Piper Sandler. Your line is now open.

Speaker 4

Thanks. So, I appreciate you're not providing full year guidance, but maybe I'll sort of 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 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.

Speaker 2

Sure, David. So, I think you saw from our earlier slides that, we believe that the total accessible the total addressable market here of activated patients is on the order of 10,000,000 to 12,000,000. We estimate that approximately 1 third of that population is cared for in the specialty universe. So that would be mostly ENT and allergy specialists where we are currently deployed. Our 75 territories, with 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.

Speaker 2

So we think we have access to a large part of that segment. Is that addressing the question you asked, David? Yes, that's helpful. And then maybe as a follow-up to that, I know that payer dynamics are particularly important. Can you talk to the nature

Speaker 4

of the dialogue you've had with payers and your level of confidence that access would be markedly improved to the extent you

Speaker 1

do get the label expansion?

Speaker 2

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 FDA, I can't speak for payers and the payer environment is challenging I think for everyone selling a branded product today. 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 indication as opposed to restriction to the diagnosis of nasal polyps.

Speaker 2

So that 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 office, will be able to and comfortable, in making the diagnosis of chronic sinusitis, a much broader range and with more frequency, then we're comfortable making the diagnosis of nasal polyps.

Speaker 4

Okay. That's helpful. Thank you.

Operator

Thank you. And this completes our Q and A portion. I'll turn the call back to Doctor. Rami Mahmoud for closing remarks.

Speaker 2

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 assertive launch of the product into the marketplace starting in Q2. 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 farther forward into the future with other ENT and allergy products that are synergistic with the product we're selling today.

Speaker 2

So again, thank you for joining this morning.

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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OptiNose Q4 2023
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