OptiNose, Inc.
Q2 2019 Earnings Call Transcript

Published: 12 Aug 2019

[Operator:]

Good day, ladies and gentlemen. And welcome to the Optinose Q2 2019 Earnings Call. At this time, all participants are in a listen-only mode. Later we will conduct the question-and-answer session and instructions by that participate will follow at that time [Operator Instructions]. As a reminder, this conference call is being recorded.I would now like to introduce your host for today's conference Mr. Jonathan Neely, VP of Investor Relations. Sir, you may begin.

[Jonathan Neely:]

Good morning. And thank you for joining us today as we review Optinose's second quarter 2019 performance and our plans for the remainder of the year. I'm joined today by our CEO, Peter Miller; our President and Chief Operating Officer, Ramy Mahmoud; our CFO, Keith Goldan; and our Chief Commercial Officer, Tom Gibbs. The slides that will be presented on this call can be viewed on our Web site, 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.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 of Optinose's most recent Form 10-K and Form 10-Q that are filed with the SEC and available at their Web site, sec.gov and on our Web site at optinose.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 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 Peter Miller. Peter?

[Peter Miller:]

Thank you very much, Jonathan, and good afternoon everybody. We appreciate you joining us for our second quarter update. We're excited to discuss the continued strong growth in demand for XHANCE and our plans to sustain that growth.Starting on Slide 3. I'd like to start by providing an overview of key highlights that we will review in more detail throughout today's presentation. The lead headline is that our promotional team has once again delivered strong growth in the number of XHANCE prescriptions. Second quarter 2019 marks a third consecutive quarter in which XHANCE prescription quarter-over-quarter growth was 50% or more. Importantly, this growth is not just from new prescriptions as both new prescriptions and refills are growing. Also encouraging for our long-term business potential is that, while growth has been strong over the past few quarters, there remains tremendous upside potential for XHANCE. We are steadily growing both prescriptions and share. But the market is so large that we believe we are just starting to scratch the surface of the overall market potential.In second quarter, we estimate the average net revenue per XHANCE prescription was $197, up from $177 in the first quarter. For the entire first half for 2019, that produces an overall average net revenue per prescription of $189. In light of these results, we continue to believe in our full-year guidance range of $185 to $205 for average revenue per prescription. Our growing volume, coupled with an increasing average net revenue per prescription, yielded strong net revenue growth. Today, we reported net revenues of $6.7 million in the second quarter of 2019, an increase of 68% over first quarter. And we are providing full-year revenue guidance for the first time. For full year 2019, we expect $29 million to $34 million of XHANCE net revenues. In addition, we are lowering our expense guidance for full-year 2019, and our cash position is formed at $144 million as of June 30, 2019, which allows us to continue to focus on the launch of XHANCE.And last, we have exciting new post hoc analysis from our clinical trial data showing that patients who are on a traditional intranasal spray for at least 30 days private trial entry improved when switched to XHANCE. We believe this analysis has the potential to further strengthen the efficacy message for XHANCE and to provide additional evidence of the value of the product and our discussions with payers.Turning to Slide 5. We have confidence that our current commercial strategy is strong, as evidenced by the significant growth of experience over the past 11 months. Therefore, we are committed to sustaining and strengthening its core elements, while we also introduce additional accelerators as we move forward.Key objectives of our integrated commercial strategy include, communicating how XHANCE is differentiate on efficacy, driving new patient starts within our target nasal polyps patient type and supporting patient access and affordability. While we have many elements that are successfully driving this strategy, we've highlighted several areas that have potential to continue to drive growth. One example I mentioned earlier is compelling data from the new post hoc analysis from a pivotal trials that will describe in the next slide.We also have a growing library of nasal endoscopy videos that we are sharing with physicians to tangibly illustrate the effect of XHANCE on nasal polyps in a compelling way that can be observed directly, both will add to the already strong case that is helping differentiate XHANCE on efficacy when we meet new physicians. The market for XHANCE is sizable. So despite our uptake, the opportunity to start new patients on XHANCE remains very large. Therefore, we have added new drivers to support this component of our commercial strategy as well.At the start of second quarter, we increased the number of sales territories for XHANCE by 25%. We are encouraged by the initial progress of the territory managers we hired to promote XHANCE to a new universe of high potential target physicians. In addition, we deployed a new seven day sample in Many that is in my opinion better describe as a starter kit for new patients. Care with prescription, the seven day sample has enough product for the patient to start and maintain treatment, while they have the first prescription filled. I'll detail this more in a moment.I'm also excited to announce that we have initiated a multichannel channel DTC pilot in Charlotte, Cleveland and Hartford. The pilot is designed in the test versus system fashion to help inform us that there's potential for XHANCE if also marketed directly to patients. Third, we invest a great deal of time and energy in understanding and improving market access and affordability. In today's environment, this is vital to drive product adoption by both patients and physicians. Our primary opportunity for XHANCE is with commercially insured patients, and we estimate that nationally based upon third-party syndicated the data and internal analysis, that greater than 75% of those lives are currently in a plan that covers XHANCE.In addition, we recently signed a contract with one of the largest health plans in the country that enables expansion of our target physician universe. In addition of the lives covered by commercial plans, we are also making progress in negotiating and signing contracts for XHANCE to benefit patients covered by Medicare and Medicaid plans.Turning to Slide 6. Efficacy is an important reason for physicians and patients to start using XHANCE and efficacy therefore is a key part of our commercial messaging. Because XHANCE is a nasal steroid differentiated by our unique breath power delivery system, one question we get is whether the product is effective in patients who still have symptoms despite the use of other nasal steroids in a traditional delivery system. Because almost all patients on our pivotal trials have previously tried nasal steroid treatment, we're hoping to address that question with a new analysis of the 30% of patients who reported use of a nasal steroid in a traditional delivery system for at least 30 days immediately prior to entering the trials. All patients had bilateral nasal polyps and moderate-to-severe symptoms at trial entry and when switched to XHANCE experienced improvements. Slide 6 shows the improvement of people switching from other rental steroids to XHANCE on endpoints, including congestion and nasal polyp grade. This new analysis is an example of one of the tools we anticipate using to help further differentiate the profile of XHANCE in the second half of this year.Turning to Slide 7. Another factor which may work to drive future revenue growth is direct-to-consumer communication. We have taken a disciplined approach to DTC, learning first through a digital pilot that started in November 2018 and ended in April 2019. As our next step, we have launched the multichannel test market pilot this week in Cleveland, Charlotte, and Hartford that we expect to run into November.We'll evaluate the impact of the upcoming pilot before committing to a broader DTC program next year. However, we believe such a program would be likely to focus on key markets and one during time periods that we believe DTC will be more efficient. Finally, many of you on the call have asked us if the advertisement we are using in broadcast during the test pilot will be available online. We anticipate that the broadcast of that will be available in several places, including on YouTube and the XHANCE Facebook page next week.Turning to Slide 8. I am very encouraged by the continued strong growth in prescription volume we have observed through the first half of 2019. The number of XHANCE prescriptions in the second quarter of 2019 was nearly 34,000. This represents growth of 51% over the first quarter of 2019 and is the third consecutive quarter of prescription growth at or above 50%.Moreover, as we enter the third quarter 2019, we can report 17% month-over-month growth for July over June, a strong start to the second half of 2019. It is also encouraging for future growth of XHANCE that the overall growth in the second quarter is driven by growth in both the number of new patients and the number of refills. And that the proportion of total prescriptions attributed to refills is continue to increase as we begin to see more patients using more moths of XHANCE to treat their chronic condition.Slide 9. We believe there's a large market for XHANCE, and that is one reason for significant headroom for long-term growth. One way to evaluate that potential is with the XHANCE share of intranasal steroid prescriptions written within our target physician audience. To be clear, most of the INS prescriptions written within our target additional physician audience are for chronic sinusitis, allergic rhinitis and other conditions outside of our nasal polyp indication, but this is a measure of share we track.While the share has grown rapidly by more than a factor of three in 2019 from 0.9% in December of last year to 2.9% in July, the low absolute size of the share illustrates the overwhelming opportunity for XHANCE growth that still lies ahead within just our current target audience. In a few moments, I will update you on our chronic sinusitis program and provide some closing remarks.And now, I will turn the call over to our CFO, Keith Goldan, for comments regarding second quarter results and perspectives regarding full year 2019. Keith?

[Keith Goldan:]

Thank you, Peter and thank you to everybody joining today. Turning to Slide 11. As we reported after market close, Optinose recognized $6.7 million of XHANCE net revenue in the second quarter. As noted on prior calls, one of the metrics that we track is average net revenue per prescription, which is calculated by dividing net revenue for the quarter, by the estimated number of XHANCE prescriptions dispensed during the quarter. We believe this is a useful metric to evaluate the net revenues generated per prescription. However, we remind you that this metric is subject for variability.That variability is a result of factors that do not necessarily reflect a change in the price that is paid for an individual unit of XHANCE, including ordering patterns and inventory levels for our wholesale customers and pharmacies that we sell to directly, utilization rates of patient affordability programs, the proportion of patients acquiring XHANCE through an insurance benefit and other factors.Based on available XHANCE prescription data purchased from third-parties and data from our pharmacy partners, our average net revenue per prescription for the second quarter of 2019 was $197, which was an 11% increase, compared to the first quarter average of $177. The increase in the first quarter was primarily due to our need to provide less co-pay assistance as more patients need out of pocket limits following the annual reset of insurance deductibles, commonly in January.Typically, once a patient meets their out of pocket threshold for the year, insurance benefits pick up more of the out of pocket costs for prescription drugs, which in turn reduces the amount of co-pay assistance provided by our affordability program. For the first half of 2019, overall average revenue per prescription was $189, which falls inside the range that we continue to expect for the full year, which I'll review further in a moment.Moving to Slide 12. As highlighted in our earnings press release, we're providing XHANCE net revenue guidance for the first time. We expect full year 2019 XHANCE net revenue to be in the range of $29 million to $34 million. As a product in launch phase, we waited until the second half of the year before providing full year guidance in order to have more information regarding product demand and average net revenue per prescription. We may elect to take a similar approach in the future. In addition, we continue to expect that the full year 2019 average net revenue per prescription will be between $185 million to $205.Finally, for the second quarter of 2018, operating expenses were $31.3 million. Based on that and our strong commitment to be efficient with our cash, we're reducing our full year 2018 expectation for total operating expenses to find a sales general and administrative plus research and development expenses to be in the range of $128 million to $133 million. Of which, $10 million to $11 million is expected to be stock based compensation. Total operating expenses, excluding stock based compensation, are expected to be in the range $118 million to $122 million. Previously, our guidance for total operating expenses range was $135 million to $142 million. Thus, the midpoint of the new guidance range is $8 million less than the midpoint of the old range.I will now turn the call back over to Peter to give a brief pipeline update and closing remarks.

[Peter Miller:]

Thanks, Keith. Turning to Slide 14. In addition to launch of XHANCE, we believe significant additional long-term value could be created by follow on indication for the treatment of chronic sinusitis for the purpose of accessing a broader target audience. As we mentioned before, this is an indication for which we are aware of no current FDA approved drug treatments. It is a condition with very high prevalence, which is treated by substantially larger Universal physicians with guidelines currently calling for off label use of nasal steroids.In the second quarter of 2019, we initiated the second of two trials, and focused on the execution of our plan to activate clinical trial sites. Although, multiple sites are now screening in and enrolling, we are continuing to add additional investigational sites with an emphasis in the second half of 2019 on activating global sites, particularly for the second trial.Turning to Slide 16. In conclusion, we are very encouraged by the sustained quarterly growth in prescription volume that we are reporting today. Our achievement of our expected trends in average revenue per prescription and our reporting on steady growth and refills as a business driver, as well as planned actions to sustain continued growth help round out the picture for today, while our growing yet still modest share penetration is indicative of the large market that offers great potential for tomorrow. I look forward to our future updates.Thank you. And now, I'd like to open up the call for Q&A.

[Operator:]

Thank you [Operator instructions]. Our first question comes from Randall Stanicky with RBC Capital Markets. Your line is now open.

[Ashley Ryu:]

Hi. Good afternoon. This is Ashley Ryu on for Randall. I just wanted to talk a little bit more about that 2Q number. I'm just trying to understand if you start to see any benefit from the increased sales territories? And can you talk a little bit about the impact if any in 2Q from seasonality and the increased sales territories compared to the growth driven by new prescribers in existing territories, the increase of retail, that kind of thing. Basically trying to just understand the "same store growth", if you will?

[Peter Miller:]

I'll start and then Tom maybe you can add some color. But thanks for the question. And really, the majority of the growth in 2Q was driven by what we call the old territories, if you will. So the 80 territories that we're in place prior to our expansion last April, there was some modest contribution in Q2 of the territories. But as we said on prior calls, we really did not expect much contribution in 2Q, and we really didn't get much contribution in 2Q. We do, as I said in the prepared remarks -- we believe that really could be an accelerator in the back half of the year. There is no doubt about that.So the growth really was driven by what we call our organic, if you will, territory managers. Relative to seasonality, there really is a seasonal impact. And obviously, anybody who followed us last year know that that's something we talked about. We're very, very encouraged that we grew right through that seasonal impact, as a result of two things; we were able to continue to grow new prescriptions, because of our patient affordability program; and most importantly, the great progress we've made on physicians really understanding we have a differentiated efficacy profile; but we continue to just believe that we are going to be able to -- and also refills is the second thing that really contributed to the growth. But, Tom, I don't know if you have anything to add.

[Tom Gibbs:]

Sure, just maybe a couple of things. And thanks for the question. As Peter said, I think we were very pleased with the strong growth that our, what we call, our legacy territory managers were able to generator during the second quarter. Now with that said, we feel really good about the people that we've hired into the new territories. And I'm pleased with the early progress that they are making. So we know that it takes time for new territory managers to access target physicians to increase product awareness and build appreciation for the clinical differentiation of XHANCE. As they achieve these objectives, we expect them to contribute meaningfully in the back half of the year. So overall, very encouraged by both our legacy territories, as well as what we're starting to see from our new territories.

[Ashley Ryu:]

I just had a few quick follow ups. Do you then also, I guess, expect that seasonality to impact 3Q? And I know you mentioned the 17% growth in July versus June. Can you just confirm whether you expect month-over-month growth to continue through 3Q? And then the last one is just, if you can quantify the portion of refills versus the new patient starts that you've seen this quarter? Thank you.

[Peter Miller:]

On the season -- and Tom, again, you could add color. But the trough of the season is really in early to mid July. So we're through the worst of it, which we're very encouraged by the strong 17% growth we had in July. We grew right through that downturn that you see in the season in June and then into July. So from here forward, the category is a -- or the seasonality will be a tailwind for us. Tom, anything to add on that, further to refills?

[Tom Gibbs:]

Just to give a little bit specific on the market dynamics. In June, we saw for the intranasal steroid market a 17% decline in the market. And then in July, there is basically 0% growth. So as Peter said, the trough of the intranasal steroid market is behind us and we expect to have a bit of a tailwind as we move into the latter part of the third and fourth quarter.

[Peter Miller:]

On the refill, we're not disclosing at this point in time proportion of refills. Although, I did mention in my script that because we're seeing very good acceleration of refills, the proportion of refills is growing relative to the overall proportion of total prescriptions. But at this time, it's something that we're not disclosing. I will say, we continue to feel very good about our refill rate.

[Operator:]

Thank you. And our next question comes from David Amsellem with Piper Jaffray.

[David Amsellem:]

So just a couple, so first on the net revenue for Rx, I know it's a little bit early to talk about. But any color on how we should think about 2020? I think as you began the initial launch, you had net revenue for Rx expectations and you talked about it potentially being over the $200 range or even a little bit north of that. So help us understand maybe longer term where you think that trends? That's number one. And then number two, apologize if I missed this. But can you give us some flavor as to a portion of usage in non-polyp patients and also patients who have allergic rhinitis and where that stand these days? Thanks.

[Peter Miller:]

Keith, I'll pass the first one to you.

[Keith Goldan:]

David thanks for your question. So the longer term average net revenue per script guidance, we actually never gave guidance. When we were referring to the $200 million to $250 million range in the past, we were using that as an example in our TAM analysis. And we're building up the total addressable market and that was based on some other pricing in the market. But as we've reported we've, on a quarterly basis, exceeded the $200 million mark as we did in 4Q last year when I think we were at $214 million average net revenue per TRx. So, we're not getting guidance past this year. We're affirming the comfort with the range that we've given the $185 million to $205 million. For the first half of the year, we're already within that range at $189 million, saw a very nice increase up to $197 million. Again, approaching $200 million mark in 2Q. The longer term view is really going to be impacted largely by our contracting strategy, and how that dovetails along with our co-pay affordability program which works in conjunction with our contracting strategy to make the drug affordable to the patients.

[Peter Miller:]

Keith, I think that's right on. And the other thing, David, you know is that because we still have room to grow in our percent of prescriptions that are covered and we do have line of sight to continue to increase the percent of prescriptions that are covered, that's a potential upside. And as our business shifts more and more to refill, that's also potential on the favorability side. But I think Keith is right to point out, there is real pressure, obviously, on the payer side, on the contracting side. We're very -- we feel very good about our current position. But as you look forward, there's probably going to continue to be pressure across the board, not just with us but all pharmaceutical companies. Second question, Tom, I'll pass to you.

[Tom Gibbs:]

Thanks for the question, David. As you know, our promotional efforts are focused on educating HCPs on the utility of XHANCE in treating nasal polyps. However, physicians can prescribe medications outside of indication based upon their clinical expertise. The data that I'll share with you is based upon patient claims data. These data suggest, just under 52% of all prescriptions for XHANCE are written under the XHANCE -- the chronic sinusitis umbrella, about half in chronic sinusitis, about half in nasal polyps. All other represent about 48%. And the majority of those prescriptions are for allergic rhinitis, which is just under 25%.

[Operator:]

Thank you. And the next question comes from David Steinberg with Jefferies. Your line is now open.

[David Steinberg:]

Couple of questions. First, I know you initiated the seven days starter packs recently. Any color from the field on what percent -- what the fill rate is, how many people have actually started on the starter packs, converted to paid scripts? And then secondly, just back on ASPs. It looks like you put in a 5% price increase on July 1st. So just curious in terms of the guidance for the year, should hit gross to net might worse a little bit? Or could you be, given the price increase and the $20 jump from Q1 to Q2, I assume you beat the upper end of the range, or could even top to the 205 top of the range for pricing this year? Thanks.

[Peter Miller:]

Tom, I'll let you handle the first one.

[Tom Gibbs:]

As you know, our territory managers began distributing the seven day samples back in May. The early feedback from the territory managers are physicians are very excited to have this tool available to them to help them assess the efficacy of XHANCE for their patients. We're pleased with the preliminary qualitative and quantitative analyses that we've done to-date. But it's really a bit too early to do a true promotional response analysis on the utility of the two.

[Peter Miller:]

David, something I'll say is we were just running a lot more samples than we were in 4Q and 1Q.

[Tom Gibbs:]

Just to be more specific on that. If you look at the number of samples in Q1, we're just about 13,000. In Q2, it was just over 21,000.

[Peter Miller:]

Keith, I'll pass the second one to you on ASP?

[Keith Goldan:]

David, the guidance that we gave with respect to average net revenue prescription is givenwith the knowledge that we effect of the price increase as of July 1. Don't forget the -- a lot of that increase doesn't come to the company. And the average net revenue per prescription that report takes into account all the gross to net deductions, including distribution service fee, payments to the wholesalers contract rebates that we pay to the PDMs and payers and co-pay affordability, those are the three largest. But the guidance fully factors in the price increase.

[David Steinberg:]

And just two quick follow-ups. So when you initially launched the product, I believe about 50% of the scripts went to specialty pharmacy. And then throughout the launch you can see, there've been some big weekly jumps in reported IQVIA data, but still some is not going to retail pharmacy. Can you give us up-to-date ratio of retail scripts versus specialty pharma scripts? And then the second question is just on business development. If the CRS studies readout, you have no indication a couple years, but you still have one product that's in the bag. And I know the company has limited resources. But are you actually looking at any BD opportunities to in-license or purchase another asset for your sales reps to carry in the bag?

[Peter Miller:]

Keith, I'll let you handle first one, I'll take second one.

[Keith Goldan:]

David, thanks for that question, because it's good to get everybody aligned. So currently, we believe that IQVIA, which is the data provider that we use primarily is picking up approximately 85% to 90% of the prescription volume, inclusive of retail and those specialty pharmacies that are in our -- that participate in our preferred pharmacy network. I would say, I would urge you to use caution in looking at any single week sometimes when we look at that data, because we have more transparency, more visibility because we get direct reporting from our specialty pharma partners. We've seen that dip below that 85% mark, again, on a week-by-week basis. But overtime, we believe they're picking up 85% to 90% of prescription volume.

[Peter Miller:]

Yes, David, the thing I'd add that too, obviously, there is a separate factor of the percent of business that's in retail versus our PPN network, and it's the same number, obviously, different measure. But about 85% to 90% of our current prescriptions are going through our PPN network. We happen to think that's an advantage, because we get higher first sell rate than you see at retail, we also get a higher refill rate.

[David Steinberg:]

And then on the business development question?

[Peter Miller:]

Actually, by the way, David, I apologize, I misspoke there, 75% to 80%.

[Keith Goldan:]

75% to 80% of our prescription volume is flowing through PPN.

[David Steinberg:]

And just on the business development question?

[Peter Miller:]

On BD, David, as we've said from the start, our ambition is to build a leading ENT and allergy specialty company and you obviously can't do that with just one product. From now, our focus is in ensuring that we build XHANCE. So in the near-term, that's our focus. Having said that, we are actively looking at potential products we could bring in the bag. And I'll just stop there.

[Operator:]

Thank you. And our next question comes from Brandon Folkes with Cantor Fitzgerald. Your line is now open.

[Brandon Folkes:]

So I guess maybe have you started to engage with payers for 2020 have yet -- with 75% covered lives at the moment. Should we expect this to be a moving event for the year from your transformation?

[Peter Miller:]

Tom, I'll let you take that one.

[Tom Gibbs:]

Sure. Thanks, Brandon. We continue to engage payers and try to drive our, what we call, hassle-free or low hassle market access through the commercial segment. We're working in two different areas. The first on the commercial side, we continue to drive and expect to increase our market access as we move into 2020. We've had -- we just signed, as we talk about, one of the largest health plans in the United States this past month, and then we continue to engage other payers as well. Also on the Medicare Part D front, as you know, these are annual cycles. We're engaged in the Medicare Part D cycle and we expect to increase our access in 2020 there as well.

[Brandon Folkes:]

And then maybe one follow up, on the reduction in OpEx guidance, given that you are in a large new start at DTC campaign, can you give us some color in terms of where you are finding those savings, and how much leverage there may be in the business model? Thank you.

[Peter Miller:]

Keith -- I'll let you take that, Keith.

[Keith Goldan:]

So thanks, Brandon. So I can tell you that the reductions in the OpEx guidance was not driven by a need to find savings, especially in our commercial organization. As you say, we're in a launch and we feel we're investing appropriately. The savings were I would categorize them, as more driven by efficiencies within the business and our focus on being judicious with our expenditures. With respect to leverage, I think we do -- I think the BD question that came earlier was one about leverage. We have capacity in the field force. But today, we think that capacity is best used to focus on a XHANCE because that's what's going to drive value in the near to midterm. Obviously, looking out longer as Peter commented, we believe that there is the opportunity to leverage the asset, the commercial infrastructure that we've built and get more juice out of that asset.

[Peter Miller:]

I'd add to that, Keith, also just general SG&A that we built a company from the areas outside of commercial, but it's very leveraged as well. So it's obviously something that is part of our strategy. And it's going to become a focus once we are absolutely certain that we have XHANCE where it needs to be. And we feel very good about the business based on growth in the second quarter and growth in July.

[Operator:]

Thank you. Our next question comes from Gary Nachman with BMO Capital Markets.

[Gary Nachman:]

Back on the net revenue per Rx. Any reason to think it shouldn't continue to increase in the second half versus the third quarter, especially if refills accelerate the way you're talking about, Peter? And then maybe more broadly. Just what is some of your key assumptions embedded in the full year sales guidance? How much more share capture are you assuming? What the biggest drivers behind that range to give us comfort that you could hit that ramp in the second half?

[Peter Miller:]

Keith, I'll let you tackle the first one.

[Keith Goldan:]

Gary, unfortunately, we're not going to be any more specific other than kind of affirming our confidence in the range. There's certainly some tailwinds, as Peter mentioned, like the proportionality of refills. Some of it depends on our contracting strategy. So we're just not going to comment further than given this audience confidence that we're going to be landing in that range for the full year.

[Peter Miller:]

And Gary, relative to full year net revenue, you know as well. We really look hard at the data and the facts supporting it. And I'm going to state what's obvious. But the midpoint of the range is roughly a doubling of our first half of the year. We achieved $10.7 million in revenue for the first half of the year. You go to the midpoint in the range $31.5 million, that's about a doubling. And when we look at the underlying dynamics, as Tom mentioned earlier. We sort of split the analysis into our legacy territories, and then our new territories. And we feel really good about the trends in our legacy territories.I mean, they are, we just seen growth virtually across the board. And Tom mentioned as we feel great about our sales team. The one that's a little bit harder to predict is going to be when the new territories really come on board and start contributing. We obviously have is an analog last year. But frankly, the patient affordability was a little bit different, it's a little bit harder to predict on that side. But those are the big factors. We have -- we really feel good about having our arms around average net revenue per prescription, so it's going to come down to volume. And we're feeling really good about the business right now.

[Gary Nachman:]

And then, Peter, what else could you do to kick start further prescription demand. I know you have a lot of initiatives in place. But would you consider some type of creative commercial partnership, maybe before having the CS indication in hand. And maybe, Ramy, could just give a quick update, just how you see those trials progressing? And what's a likely timeframe for when you could have the data on that?

[Peter Miller:]

Yes, and I'm going to state the obvious, Gary, on the first question which is, there are interesting partnering opportunities in the ENT allergy space for acceleration. And those are certainly things we are looking at, at this point in time. And it's -- our business is all about how do we accelerate growth in the near term on XHANCE and then how do we build a company, an ENT allergy company in the longer term, which obviously will be bringing some new products in. So obviously, without -- I want to be careful disclosing anything. But we are looking at ways to accelerate beyond just organic growth. With that, Ramy, I'll let you tackle the second question.

[Ramy Mahmoud:]

Hi, Gary. Thanks. I just want to remind you that we started the first chronic sinusitis trial in the fourth quarter of last year 2018. And the second trial just this last quarter we're reporting on second quarter of 2019. And in the first half and getting the trials going is really to get the sites up and running. Most of the U.S. sites are on board now but a lot of our global sites have a longer time lag on them, because of the necessary approvals in other countries to be able to initiate the trial. So we're still very active in trying to get a lot of those global sites up and running.It's hard for us to give confident estimates about when we're going to see the final data from these trials, because of unknowns about the enrollment rate and some other factors. These trials are first in class. This indication has never been achieved before. It's not a territory that's well understood based on precedence. But we do expect to understand it better after we get more of our heterogeneous sites around the world up and running later this year.

[Gary Nachman:]

And one last quick one, Peter. Are you going to have the post hoc analysis? And are you going to try and get it in a publication, maybe sometime in the near future? How are you going to be able to go at and market that?

[Peter Miller:]

Absolutely, Gary. And we are we are planning to make sure that we take all the areas that are open to us to make sure that physicians become aware and payers. It has compelling data on both sides. But publication is absolutely part of it.

[Operator:]

Thank you. And I'm showing no further questions in the queue at this time. I'd like to turn the call back to Peter Miller, CEO, for any closing remarks.

[Peter Miller:]

Well, thanks very much for the questions and for all who joined today. Hopefully, you can tell by our remarks throughout, we just feel really good about the business right now. We think we've landed on the right strategy to grow XHANCE. We think the execution of our commercial team has been very strong, over the past six months actually to over the past nine months. And we're very excited about back half of the year. So thanks for joining us.

[Operator:]

Ladies and gentlemen, thank you for your participation on today's conference. This does conclude your program, and you may also disconnect. Everyone, have a great day.