Q2 2022 OptiNose Inc Earnings Call
Good day, and thank you for standing by welcome to the second quarter 2022 earnings call.
At this time all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session.
To ask a question during the session you will need to press star one one on your telephone.
Then here an automated message advising that you had this race.
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I would now like to hand, the conference over to your first speaker for today, Mr. Jonathan Neely, Vice President of Investor Relations. Please go ahead.
Good morning, and thank you for joining us today as we review after notices second quarter 2022 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, Ryan on mood.
And our Chief commercial Officer, Vic Gabelli slides.
Slides that will be presented on this call can be viewed on our website at <unk> dot 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 are 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 are often the most recent Form 10-K and Form 10-Q.
That are filed with the SEC and available at their website SEC Gov and on our website at after notice Dot com.
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.
Thanks, Jonathan and good morning, everybody. We appreciate you joining us today.
Starting on slide four.
We'll go into more detail in a moment, but I'd like to highlight four key takeaways from today's presentation.
First we reported topline results from reopened two in the second quarter and we're pleased with the positive results.
We believe the reopened program is a landmark in chronic sinusitis as it is to our knowledge. The first phase III program for which a nasal treatment as shown improvement on both symptoms and measure of inflammation inside the sciences.
We view this as an important development for the approximately 30 million adults in the United States, who suffer from the symptoms of chronic sinus disease. One of the most common chronic diseases of the adults in the United States reported to drive 10 million outpatient visits per year.
Second our clinical and regulatory teams are seizing the opportunity created by the reopening program to pursue a supplemental approval for <unk> as a treatment for chronic sinusitis.
We are very excited by the potential for the new indication would create and I'll discuss that briefly on the next slide.
Third we implemented a change to our copay assistance program at the start of 2022 to reduce the co pay assistance, we provide for unprofitable prescriptions filled by patients with high deductibles.
That change is having the intended effect of reducing the number and proportion of that type of unprofitable unprofitable prescription, which is driving a 12% increase in average net revenue per prescription for the first six months of 2022, when compared to the same period in 2021.
Fourth we revised our guidance for full year 2022, <unk> net revenues and operating expenses.
<unk> net revenues increased 21% in the first six months of 2022 compared to the same period a year ago.
That is strong growth and within reach of our prior guidance, which was at least for $90 million and net revenues, which implies at least 22% growth for the full year.
We're still working to deliver more than $90 million, but for reasons that I will discuss in a moment, we believe the $85 million to $92 million is the right guidance to provide for full year 2022 at this time.
We've also reduced our full year 2022 operating expense guidance by $6 million to offset the reduced expectation for net revenues.
Overall, we're taking an approach of smart growth with its hence with its current nasal polyp indication while preparing for the much larger opportunity, we see with a chronic sinusitis indication.
Turning to slide five.
Our excitement for the reopened program centers around the potential for a first ever indication for the treatment of chronic sinusitis has to significantly increase our target patient population.
We anticipate increasing our current diagnosed patient population from up to 1 million patients with nasal polyps. The current indication for <unk> to a much bigger patient audience of approximately 10 million by adding those who are already diagnosed with chronic sinusitis.
With our current commercial infrastructure, we call on a physician universe focused on the A&P analogy specialists, who treat most of the up to 1 million diagnosed nasal polyp patients.
While this is a sizeable market that we believe represents a total market opportunity for approximately $1 billion at our current value per patient.
A new chronic sinusitis indication would triple the promotional accessible patient population treated by our current target group of physicians to 3 million, increasing the market opportunity to approximately $3 billion.
All of which can be accessed without significant incremental investment in our commercial infrastructure.
On top of that there was there was an opportunity for potential partner with the primary care infrastructure in.
In addition to the 3 million patients currently treated in our specialty physician target audience. There are an estimated 7 million additional patients currently diagnosed and treated by roughly 50 to 60000 additional physicians in primary care.
It's incremental physician audience and patient population represent an additional market opportunity of approximately $7 billion.
For our partner and primary care. There are an additional estimated 20 million patients who suffer from symptoms of the disease, many of whom are likely aware of their diagnosis, but we're no longer receiving active care.
We believe these patients are not well, but have given up on regular physician visits.
Feeling forced to rely on over the counter remedies because they do not believe what their physician has historically been able to offer them for prescription medical treatment surgery, a repeat surgery will meet their needs in.
In summary, we believe this dramatic potential expansion of our target audience can be a true game changer for our company in the near term.
I'll now turn the call over to Ronnie to discuss the results of the reopened program and next steps Rami. Thank.
Thank you Peter turning to slide seven.
I'd like to start by thanking the clinical research team at <unk> for their work on the reopening program without their efforts, particularly through the worst periods of the pandemic. These trials would not have been possible to bring to completion.
We opened one and reopened to have produced landmark results in the treatment of patients with chronic sinusitis.
On this in the following slides I will describe some of the key efficacy findings from the two trials.
The first co primary endpoint evaluated in each of the reopen trials with the mean change in combined symptom score at week four.
We believe this result is important because it symptom relief as a primary objective and treatment of patients suffering from chronic sinusitis and contributes to understanding of the clinical importance of the treatment.
And reopened one and reopened two patients started the trial with moderate moderate to severe symptoms.
In both trials and for both active treatment arms <unk> treatment produced statistically significantly more improvement in symptoms.
As reported by patients using the placebo comparator.
Magnitude of this improvement was consistent with the magnitude of improvement in the prior acts hands clinical program that supported the initial approval of the product by the FDA.
Turning to slide eight.
The second co primary endpoint in each of the reopen trials was a measure of the amount of inflammation inside the ethmoid and maxillary sinuses.
This was a SaaS using computer assistance to evaluate the three dimensional final spaces and objectively quantify the average of changes in the percentage of pacification of the sinus cavities after 24 weeks of treatment.
Although changes in imaging are not routinely used as either a treatment objective or as a way of tracking a patient's response to treatment. We viewed the second endpoint is important because it establishes whether a treatment effect is occurring inside the sinus cavities as distinct from a treatment effect inside the nasal cavity as we have previous.
Reported with nasal polyps.
At the time of entry into reopened one and reopened to all patients were required to have at least a minimum level of sinus opacification in order to prove the disease was present inside the sinus cavities.
In both trials and for both active treatment arms, we found statistically significantly more improvement in sinus opacification for treat patients treated with <unk> compared to those receiving the placebo comparator.
Previously shared images to show how our obvious this amount of mean change is on an ordinary two dimensional scan image.
But in addition to that we have now performed analyses.
Show that this amount of mean change was accompanied by a meaningful improvement in disease as perceived by patients, which we measure using the patient global impression of change.
As Peter noted earlier, we believe that these results from the reopened program Mark the first time ever that a phase III program testing and nasal therapy for chronic sinusitis has been able to show improvements in both symptoms and inflammation inside the finances.
Turning to slide nine.
In another noteworthy first reopened as the first phase III program, we are aware of ever to show that the nasal therapy can significantly reduce the number of acute exacerbations of chronic sinusitis.
As with other respiratory diseases, such as asthma and COPD acute exacerbations of chronic sinusitis are both common and important <unk>.
Exacerbations are a major source of disability for CF patients.
Data suggest that there are $10 million or more physician office visits for CFS annually and that approximately 70% of the patients who visit a doctor for CFS receive an antibiotic making this a top driver of all ambulatory care antibiotic use in the United States.
Frequent antibiotic use has been found to mediate the harm to quality of life suffered by CF patients and poses risks both to individuals and society.
The mean frequency of acute exacerbation was a prespecified key secondary endpoint evaluated in pooled data from reopened one and reopened two measured by acute escalations in care during the 24 week treatment period of the trials.
Escalation of care, most frequently involved prescribing of an antibiotic but accounts for other interventions as well.
We found that compared to placebo treatment <unk> produced a statistically significant reduction of 66% in the incidents of exacerbations for patients receiving two sprays twice daily.
Two sprays per nostril twice daily.
In additional exploratory preplanned analysis, similar reductions, which range from 53% to 80% in the number of Exacerbations were also found for patients who used one spray per nostril twice daily and in subgroups, either with or without nasal polyps.
We believe this first ever finding of a sizeable reduction in acute exacerbations and associated use of antibiotics could be of interest from a regulatory perspective and could also influence future treatment guidelines for standard of care in this disease.
The new data specific to patients with nasal polyps is also immediately promote <unk> with improvement of up to 80% observed in a subgroup of chronic sinusitis patients who also had nasal polyps from the reopened one trial.
Turning to slide 10.
Our roadmap for the remainder of 2022 includes a pre NDA meeting with FDA. Prior to data submission that has now been scheduled by FDA for the end of September .
Our clinical and regulatory teams have already started to work on the <unk> with a plan to submit by the end of 2022 and Forex hands to ultimately become the first medication ever approved for treatment of this common disease.
I would also like to remind you that we anticipate that the standard FDA review period for this type of application would be 10 months.
To learn more details about the reopening program, including baseline characteristics and safety information I invite you to view the replays of the topline results webcast for both reopened one and reopened two which are available in the investors section of our website and to review our SEC filings.
I'll now turn the call back over to Peter to discuss our second quarter commercial performance.
Thanks Rami.
Turning to slide 12.
We are pleased with the performance in second quarter 2022.
As I review the next three slides there are two things that we believe are important to keep in mind as they frame our year to date performance and expectations for the full year of 2022.
First is that we implemented a change to our co pay assistance program in January 2022 intended to prioritize growth in our more profitable customers and to reduce the number and proportion of unprofitable prescriptions.
We believe the year over year increase in revenue per prescription is evidence that the co pay program changes are performing as intended and that the growth rate of profitable prescriptions is greater than the overall growth rates.
This is desirable and reflected in our increasing average net revenue per prescription however, as our business mix has intentionally changed year over year comparisons of total prescription numbers will also be more difficult to interpret correctly until we have moved a year past the co pay program shift.
Second is that we experienced a greater than originally expected level of vacancies within our sales territories and softer than expected prescription volumes in June and July .
We believe the softer volumes may be the impact of these vacancies and what may have been greater than expected summer seasonal volume declines, but collectively these factors drove our decision to revise our expectations for full year 2022 enhanced net revenues.
We are optimistic that new hires that are already beginning to fill vacant sales territories over the summer combined with the return of a normal fall seasonal volume increases for the market versus the suppressed fall season experienced in 2021 due to the Delta variant will support volume growth.
We're also very excited by the novel finding in our reopened program that <unk> treatment resulted in reduced acute exacerbations in nasal polyp patients.
As Rami alluded too we plan to start actively reaching out to inform physicians about this new data in September .
That said, let me now review the results.
In second quarter 2022, there were approximately 29200, new prescriptions for <unk>, a 1% increase compared to second quarter of 2021, while the market, which includes IMS prescriptions written by any physician for any condition, a large component of which of prescriptions for allergic rhinitis increased 8% over the same.
Period.
For the first six months of 2022, there were approximately 57400, new prescriptions, a 5% increase compared to the first six months of 2021, while the market increased 11% over the same period.
Turning to slide 13.
And the second quarter of 2022, there were approximately 87600 total prescriptions for <unk>, a 6% increase compared to second quarter 2021, while the market increased 4% over the same period.
For the first six months of 2022, there were approximately 168000 total prescriptions and 8% increase compared to the first six months of 2021, while the market increased 6% over the same period.
Turning to slide 14.
<unk> market share increased from five 2% in second quarter of 2021 to five 6% in second quarter of 2022.
We remain excited about the headroom for future growth as more physicians incorporate <unk> into their practice of medicine.
Breadth and depth of physician prescribing as measured by the total number of physicians, who have patients filling <unk> prescriptions continue to increase from second quarter 2021 to second quarter 2022 as well.
Regarding breadth in second quarter, 2022, 7851 physicians had a patient fill at least one prescription of <unk>, an increase of 9% compared to second quarter 2021.
Regarding depth the number of physicians, who had more than 15 ex hands prescriptions filled by their patients in a quarter grew as well with that number and increasing by 6% from second quarter 2021 to the second quarter of 2022 with 500 physicians now in this segment.
I'll now turn the call over to Jonathan to discuss second quarter financial performance.
Thank you Peter turning to slide 16.
As we reported <unk> recognized $20 $6 million of that revenue in the second quarter of 2022, an increase of 12% compared to the second quarter of 2021 year to date 2020 to extent that revenue stands at $35 3 million, an increase of 21% compared to the six months ended June 32021.
Turning to slide 17, as we discussed on our first quarter call. We made a change of our co pay assistance program at the start of 2022 that was intended to increase net revenue and average net revenue per prescription by reducing the number and proportion of prescription bills by commercially insured patients in plans that have a high deductible, while sustaining the growth rate and covered.
<unk>, where prescriptions are profitable.
Patients who are covered but at a high deductible plan can end up costing us substantially more as a group than what we received for providing expense.
We see good evidence that this changes reducing unprofitable builds in our average net revenue per prescription results.
Based on available prescription data purchased from third parties and also on data we received directly from our preferred pharmacy network.
Panther average net revenue per prescription for the second quarter of 2022 with $235, an increase of 6% compared to the $221 of revenue per prescription in the second quarter of 2021.
Year to date 2022 average net revenue per prescription stands at $210, an increase of 12% compared to 188 for the six months ended June 32021.
Turning to slide 18.
We've revised our financial guidance for full year 2022 for both net revenues and operating expenses.
As Peter just discussed.
We now expect <unk> revenue to be between 85% to $92 million for the full year 2022.
Second our guidance for <unk> average net revenue per prescription is unchanged, we expect to see improvement in the second half of 2022 compared to the first half of 2022.
And to exceed $220 for the full year of 2022.
Third for the full year of 2022, we now expect operating expenses to be in the range from $129 million to $134 million of.
Of which approximately $9 million of stock based compensation.
Total operating expenses, excluding stock based compensation are therefore expected to be in the range from $120 million to $125 million.
Previously, we expected operating expenses to be in a range from $135 million to $140 million and so the improvement of $6 million.
Finally, we amended our agreement with Pharmacon to lower than December 31, 2022, trailing 12 month revenue covenant from $90 million to $85 million.
We believe this is important to address now given the change to full year 2022 exams net revenue guidance.
I will now turn the call back over to Peter for closing remarks Peter.
Thanks, Jonathan.
Before moving to Q&A I'll take a moment to reiterate that overall, we are pleased with the progress we made in the second quarter of 2022 and are laser focused on completing the necessary work to support an S. NDA submission by the end of 2022 and continuing to grow <unk>, hence, while we aimed for the major potential do we look forward to unlocking with the future CF indication.
Now I'd like to open the call up for Q&A.
As a reminder to ask a question you will need to press star one on your telephone please Dan Leib will we compile the Q&A roster.
Your first question comes from the line of Brandon Folkes from Cantor Your line is open.
Alright, Thanks, taking my question and congratulations on the quarter.
Tuesday.
Tuesday.
An increase in <unk>.
If you are seeing out in.
And maybe I heard the commentary on the guidance I appreciate that Sam refinements of that range.
Any change in market dynamics, you're seeing just in terms of volume in the back half of the year.
That drove that as well anything coming out of that.
The color would be great. Thank you.
Yes, maybe I'll take both of those and add in because.
Relative to physician reaction to the data first of all Brandon Thanks for the questions.
Relative to physician reaction to <unk>, we don't expect to see a lot of reaction Brandon.
For a while we.
We do plan to publish the data we think as I said, we said this is a landmark trial. So therefore, we plan to publish the data that'll be at some point later in the fall that as an opportunity for our sales reps to make the physicians aware of the data, but as of now it's <unk>.
Certainly our investigators are aware of the data, but broadly physicians are not aware of the data at this point.
Relative to the market dynamics, we're honestly sort of excited about the back half of the year Brandon B for two reasons last year, we did not really have a fall allergy season, because of the delta variant suppressing.
Visits to offices.
And we have this what we think is very exciting data on acute exacerbations. So that begs the question well why did you guys make a revision of the guidance.
As mentioned in the call we saw some softness we didn't really expect in June July .
But we also said we think that is something that as we fill some vacant sales territories. We've got a return to a normal season that we could see a real nice volume correction in the back half of the year.
Alright, Thank you very much.
Your next question is from the line of Gary Nachman from BMO capital markets. Your line is open.
Hey, guys good morning.
When you file for the expanded indication what will you be looking for on the label how broad of an indication and Peter if you are in the middle of partnership discussions.
Would a potential partner wants to be part of the filing process or it would strictly be.
Commercial arrangement for primary care.
Alright.
Alright, Thanks for the question I'll take the first part of that.
Our.
Our understanding of the Fda's current stance on this is that.
There are sort of two segments of the total chronic rhinosinusitis space.
And with our new filing for the NDA, we would expect to be indicated for the full range across both of those segments.
I'll take the second Gary and thanks for the question, Gary I am not going to comment Gary on any discussions we're having with partners. What I can tell you, though is that if you look.
Normally.
Typically deals of our type are done in between data all the way up through approval and therefore, there are instances, where a partner would be involved in the label discussions are also instances with a partner would not be involved in the partner in the labeling discussions so as I said I'm not going to comment on where we are and our partner <unk>.
<unk>.
But we continue to feel good about getting a partner.
Okay, and then maybe just talk a little bit more about the vacancy rates in the sales territories.
What you think caused that how much turnover there was.
How many reps have you locked in how quickly will you be able to fill them.
And then the exacerbation data from nasal polyps.
How much of an impact do you think that will have once the rep start promoting that.
I'll take vacancy Gary and I'll first I'll say that we're not immune to turnover in our sales force and our turnover in total is really no different than pharmaceutical industry averages. So.
We don't have a phenomenon here that is unusual we just happened to experience a little bit more at this point in the year.
In the second quarter, but I will say we've already hired.
Almost all the territories right Vic so.
And I'm really excited about the new reps were bringing on were attracting a lot of real high quality talent to the company. So it's something that I just think as normal.
It just happened to hit a little bit all at once in <unk>, but as I said, it's already been corrected relative to the hiring the.
The exacerbation data Gary is.
We will see but we're really excited about the initial interactions that we're having with physicians <expletive> and his team have done a good bit of research to understand potential reaction and.
We have to go prove it in the market, but we're very excited that this is big news as Rami sort of referenced in his discussion. This is an area that.
The use of antibiotics for this patient population is.
Is significant and our data suggests we have potential reduce that you. So as I said, we're excited we gotta go make it happen, but very very excited by the data.
Okay.
Yeah.
Mind us how many rats.
Do you think you need to effectively target the ANP, an allergen and then on the primary care side, just rough ballpark, how big of an appetite you think you would be there in terms of the size of the sales force to really tap into it. Thanks.
Yes, so Gary between 90, and 100 is where we've been in terms of the territories and for the anti allergy specialty market and we think that's the right size. So as we some of what we think is so interesting about the <unk> indication is to take advantage of that in the anti allergy opportunity, we don't need any.
<unk> sales force, we've got a terrific sales team.
Calling on all the doctors, who are high prescribers of nasal polyps, but who will also be the high prescribers of chronic sinusitis. So.
We're feeling very good relative to primary care it really depends on the breadth you want to go to Gary and I want to be clear, we're not going to build a primary care sales force. We are going to work to partner with someone who has a sales force in the primary care space. If you want to go all the way to the 7 million patients in primary.
<unk> being treated by physicians, it's 50 to 60000 primary care doctors. So that's a sales forces what Vic six to 800, sorry territory managers.
But obviously there are ways to go after that that you don't necessarily go to the full breadth that you go after the top decile.
We think a lot of volume and primary care can be captured with three 400 territory managers.
Alright, Okay thats helpful. Thanks.
Your next question is from the line of David <unk> from Piper Sandler Your line is open.
Hey, guys. This is <unk> on for David. Thanks, So much for taking my questions just two from us.
Trying to get a better handle on what patient attrition or Conversely assistance looks like.
Do you have a sense of what that is how it's evolving if at all.
As we move away from the pandemic could we see persistence rates improve to the extent that.
More patients are consistently seeing their doctors in person.
And then assuming a label expansion in 2023.
Do you guys think about the gross to net spread for expanse and payer contracting overall thanks.
I'll, let you take the second one on.
The first one we're really encouraged by persistence Isaac we have a lot of data that we get de identified patient data from our pharmacies and so we have a very consistent persistency rates. So once a patient gets on the product we see.
A consistent number of fills per year.
And patients really staying with the product so that is.
A key reason why we're building a really nice business years. So I say all the time the product really works and so when patients use it they get better and the data supports that.
As more patients get returned to doctors' offices and get care outside of that was the pandemic.
Continues to wane that as an opportunity to get continued growth.
So Dave I'll, let you take the second question, Yes, I mean, the reason we're excited about a lot of that growth is because it brings new patients and that actually allows us to introduce more patients to <unk>.
Of course, our pharmacy network is particularly good at keeping patients on therapy over time and on your second question is really about the opportunity that chronic sinusitis creeps with Payors and we're really enthusiastic about what that's going to mean for the business and nasal polyps today. There are a number of other products that are indicated for chronic sinusitis.
If there are no other indicated products.
And.
The other advantage in chronic sinusitis as both the patients and the physicians readily diagnose chronic.
Chronic sinusitis they know what it is and the availability of a treatment as an advantage not just for those positions, but also for the payers and by the way is a good thing I'll add Vic I would agree with everything you said this acute exacerbation data combined with already a very strong pharmacodynamic story that we have.
And also.
The cost of our medication relative to other options. We think is very attractive for payers and so we're very confident we're going to be able to get good coverage.
With the new indications with our payer universe.
Helpful. Thanks, guys.
Once again, you May press star one to ask a question.
Your next question is from Stacy <unk> from Cowen Your line is open.
<unk>.
Hi, Thanks for taking my questions.
Congratulations on the quarter and the progress we have a few first on the chronic sinusitis opportunity.
So would you first provide.
Following the September meeting with the FDA.
The first question and then the second is for that.
David.
The gang in September can you discuss if there are any reimbursement for patients.
Patients without nasal polyps.
So they retire a few more specs to get approval.
Yes, because the recent chronic sinusitis results is that something thats very bulker socialized with that cause friction with reimbursement and then the third question is on X. Hans Thanks for all the details and metrics for Q2, but can you discuss in more detail. What you are saying in Q3, so far specifically are we still expecting some.
Growth quarter over quarter.
And that's it thank you very much.
Stacy thanks, very much for the questions.
I think it's probably unlikely we're going to provide an update following the FDA meeting, we'll talk about it I would imagine as part of our normal call in.
<unk> Q in the November timeframe, Jonathan if you have anything to add there, yes, I mean, so the timing of our Q3 call would be.
Typically first or second week of November .
I'm not certain that the meeting minutes, we will come back in time for us to provide an update then but then certainly there'll be opportunities too.
Update investors.
Subsequent to that.
Yes, Steve I want to make sure I understand your second question about.
The information that we're taking out into the marketplace.
I don't think it will really affect reimbursement in any way if that was your question because.
We have a nasal polyp indication right now that is as we've talked about historically, we do have prior authorizations with some of our prescriptions those prescriptions typically require the position to attest that there is a nasal polyp diagnosis I don't think the any of the new data, we have is necessarily going to change that environment.
So vivek I think you'd probably agree with that yes, I do agree with it so the exacerbations as relevant in the nasal polyp population and so they are very used to thinking about exacerbations in asthma or COPD and the fact that now there will be an opportunity to talk about the chance to improve the rate of exacerbations and.
Chronic sinusitis with nasal polyps is a big advantage for us so.
I think you're clear on the Stacy the data we have is from our reopened one program, but the data is specific to nasal polyp patients. So it's within our promotional labeling.
It is another.
Good reason to tell us to give a physician for patients. They believe are appropriate for our product.
It's another good reason to prescribe the product.
And finally on Q3, Jonathan if you want to comment on that yes, I mean.
I think we really don't have.
Much in terms of complete data for Q3, we're sitting here in August .
A bit of information about July I think what we acknowledged that the softness in volumes that we saw that drove us to.
Ship, the net revenue range to 85% to $92 million was based on some softness in the June and July timeframe, but.
There's really not too much to the dataset for Q3 to date.
Okay. That's very helpful. Thanks for the clarification.
Yeah.
Okay.
There are no further questions at this time I would now like to turn the conference back to our presenters for closing.
Well I.
Thank you everybody for joining us as I said in my remarks, we're very excited about the back half of the year continuing to grow the <unk> business with our current indication, but most importantly.
Doing all the work necessary to get the product filed by the end of the year with an indication we think really be very very important to patients and also a game changer for our company. So thanks for joining.
This concludes today's conference call. Thank you all for attending you may now disconnect.
Yes.
The conference will begin shortly to raise Johan during Q&A, you can dial star one one.
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