Q4 2020 OptiNose Inc Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the op. He knows Q for 2020 earnings call.
At this time all participants are in a listen only mode.
After the Speakers' presentation there'll be a question and answer session to ask a question. During the session you will need to press Star then one on your telephone.
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Nice to hand, the call over to Jonathan Neely, Vice President of Investor Relations. Please go ahead.
Good morning, and thank you for joining us today as we review at the nose is fourth quarter and full year 2020 performance and our plans for the remainder for the year ahead.
I'm joined today by our CEO, Peter Miller, our President and Chief operating Officer, Rami My mood, our Chief Commercial Officer, Victor Valley, and our CFO Keith go Dan the slides that will be presented on this call can be viewed on our website optimists dot com in the investors section before we start I would like to remind you that our discussions during this conference call.
It 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 and the risk factors section and elsewhere in <unk> form 10-K that was filed today with the SEC and available at their website SEC Gov and on our website at <unk> Dot Com you are cautioned not to place undue reliance on forward looking statements for 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.
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 Theater.
Thanks, Jonathan and good morning, everybody.
Appreciate you joining us this morning.
Starting on slide three.
I'd like to begin by reviewing our 2020 full year results.
I'm not sure any of us would've predicted the pandemic at the start of the year in the face of significant pandemic related headwinds I'm very proud from the strong growth our team delivered.
So our results were not as strong as we expected from 2020 began they reflect continued progress towards our commercial clinical development objectives.
For the full year 2020 versus 2019, Inc.
Net revenues increased 59% to $48 $4 million, a chance total prescriptions increased by 70% and accounts new prescriptions increased by 31%.
It's useful to have some context for each of these results.
Can pandemic environment had two adverse impacts on our ability to grow the business first patient visits to physician offices were suppressed due to stay at home orders and patient discomfort with going into medical offices and second the ability of our territory managers to broadly person with our targeted positions was constrained due to office does not allow.
Any sales representatives to meet in person due to the pandemic. Thus our growth in total prescriptions from 70% was against the cabin category decline of 7%.
New prescription growth up 31% was achieved in a category that declined 13%.
Note also that our revenue growth lagged prescription volume growth largely due to a temporary patient assistance program that was put in place early in the pandemic.
Program has since been retired and we expect revenue per prescription in 2021 to be more consistent with levels in 2019.
In addition, we were disciplined with respect to our expenses for.
For full year 2020, we had $129 million of operating expense inclusive of chronic sinusitis clinical trial cost.
This is aligned with our last guidance range and represents just a 3% increase compared to full year 2019.
Turning to slide for.
Well go into more detail in a moment, but I would like to highlight five key takeaways from today's presentation.
First new prescriptions of X hands. They achieved another all time high in the fourth quarter. Despite continuation of the pandemic related market challenges I already alluded to.
<unk> prescriptions increased 7% over third quarter, 2020, and are up 16% compared to fourth quarter 2019.
Its worthy to note market in Rx increased 21% from fourth quarter 2019 to fourth quarter 2020.
And I'm, sorry market Vonarx decreased 21% share.
After making certain adjustments for the effects of the COVID-19 pandemic, our full year 2020 financial performance was aligned with our company guidance.
Third we are providing some initial company guidance related to first quarter and full year 2021 performance, we hope that our ability to drive performance in 2020 lend confidence in our projections for the year ahead.
Fourth and I'll take a moment to dive in here. We believe there are multiple opportunities that will continue to drive revenue growth in 2021.
I will highlight five important factors supporting revenue growth from 2021.
The first to begin with the with the market environment.
As summarized in third party data reports the pandemic reduced the number of diagnostic visits by patients to physician offices and limited the ability of sales representatives to meet in person with physicians and importantly, these effects were not limited to the second quarter of 2020.
Broadly speaking the effects on the business environment, followed the course of the pandemic there.
There was an initial shock in second quarter improvement in the third quarter, and then softening late in the year and into early 'twenty. One is the wave of infections and deaths attributable to the Corona virus surged again.
In fact that we were able to continue to grow new prescriptions in this environment fuels, our confidence that a chance new prescription growth will further strengthen in 2021 as we expect both our access to health care offices and patient volumes in those offices to improve throughout 2021.
We think these two factors alone could provide strong support for growth for next <unk> prescriptions from 2021.
Third we believe there is an opportunity to get more benefit from our partnership with Carlyle as the pandemic environment improves since launch in fourth quarter 2020, <unk> impact on our business has not been significant as the pandemic has limited their ability to reach many of their expense targets.
Early signs of success in places, where Carlyle has been able to reach our customers leaves us optimistic about the potential for this partnership is vaccination progress serves to both east physician access make patients more comfortable resuming office visits for.
And very encouragingly, there is increasing recognition by thought leaders and specialty societies that it's hands. Please a distinct and important role in treatment of patients with chronic rhinosinusitis with nasal polyps after they try and fail conventional nasal steroid sprays.
For example.
A recent peer reviewed publication in the journal of the American Rhinologic Society, The International Forum of allergy and Rhinology from lead author, Dr. Brent Senior Chief O'brien allergy at the University of North Carolina at Chapel Hill encourage as health care providers to consider prescribing <unk> in chronic rhinosinusitis patients with nasal polyps, who remain inadequate.
Controlled by conventional nasal steroids freights.
Additionally, several medical societies, including the American College of allergy asthma, and immunology and the American Rhinologic Society have made available patient centric materials also illustrating the growing recognition of the differentiated won't look stance complained treatment.
We think that this kind of expert specialty recognition of a chance both reflects growing appreciation for the role of the product in treating the inflammation of chronic sinusitis with nasal polyps and offers potential to support to support broader adoption and making it clear that <unk> is an important option for maximizing medical therapy for patients with inadequate.
Response to standard nasal sprays.
And fifth as I alluded to earlier, we also expect 'twenty 'twenty, one revenue to benefit from a stronger <unk> average net revenue per prescription compared to full year 2020, because we do not have that.
We expect it to not field.
Assistance program this year compared to last year's program.
Finally, our last major takeaway for today's presentation is that we expect top line data from at least one of our two pivotal clinical trials of value any chance the treatment of patients with chronic sinusitis by the end of 2021.
Note that pandemic related issues, including temporary research site closures and decreased patient flows in many countries. During 2020 slowed enrollment in our trials. This is the reason we now expect top line results from one of our two trials to be delayed in the first half of 2020 instead of being available by the end of 2021 as previously guided.
As you are aware.
<unk> could be the first drug ever approved and promoted for the treatment of the 30 million U S patients who suffer from chronic sinusitis, we believe the state it could lead to a multi fold expansion of our target patient population driving significant additional value for the company potential primary care partnerships and opportunities for approval of <unk> ex U S.
Turning to slide six.
In fourth quarter 2020, there were 24600, new prescriptions for a chance a 7% increase in new prescriptions compared to the third quarter of 2020, a 16% compared to the fourth quarter of 2019, and the highest number of new quarterly prescriptions for a chance since launch.
While the pandemic interrupted our new prescription growth trend in second quarter 2020, we returned to setting record highs in third and fourth quarter.
As previously mentioned the magnitude of our full year 2020 growth was constrained by factors related to the pandemic environment, which we expect to improve for the course of 2021.
The return to growth in new prescriptions, even during the second half from 2020 when the overall market was still substantially down is a reminder of the high unmet need in the marketplace.
We anticipate the continued new prescription growth levers for the high refill rates. The result from high patient satisfaction with a chance will lead to strong total prescription growth in 2021.
Turning to slide seven.
Refill prescriptions continued to increase year over year and quarter over quarter to 49300, <unk> fourth quarter 2020, and now compromise approximately two thirds of the <unk> business.
Note that the slower flow of new prescriptions into the business in Q2 during the peak of the pandemic temporarily slowed refill growth in subsequent months. However, we see this impact washing out as new prescriptions returned to growth.
Pulling together, the new and refill prescriptions. The total number of <unk> prescriptions in the fourth quarter of 2020 was approximately 73900 <unk>.
This represents 36% growth over the fourth quarter of 2019 in a market environment, which declined 13% over the same time period.
Turning to slide eight.
As we discussed on our third quarter 2020 earnings call. We've historically defined market share as a proportion of all intranasal steroid prescriptions written by the approximately 10000 positions that were targeted by our territory managers.
Our co promotion with Clio gives us potential to reach up to approximately 3000 positions that were not in the called on universe of our own territory managers.
Given that significant change we are taking the opportunity to update the target physician audience, we used to track market share.
Going forward. We will include approximately 18000 physicians in our target audience for calculation of market share.
This target audience includes all Emt and allergy specialist physicians based on third party data right intranasal steroid spray prescriptions.
In addition, our current target audience includes specialty like primary care physicians called on by our territory managers for clothes sales representatives.
Note that all displayed historical numbers on slide eight had been restated based on this expanded universe.
<unk> market share continued to increase in fourth quarter 2020, and has increased from three 4% the fourth quarter of 2019 to five 1% in fourth quarter of 2020 and increased earned despite the previously mentioned disruption to both patient flow through doctors offices and territory manager access to physician offices.
During the pandemic period.
Turning to slide nine.
Breadth and depth of physician prescribing is measured by the total number of physicians, who have patients filling a chance prescriptions also continued to grow through the fourth quarter in 2020 as a whole.
Regarding breadth from fourth quarter 2020, approximately 6700 physicians had a patient until at least one prescription or a chance an increase of 14 per cent compared to fourth quarter 2019 from them.
Guarding depth the number of physicians, who had more than 15 <unk> prescriptions filled by the patients in a quarter is growing even faster.
With that number increasing by 54 per cent from fourth quarter of 2019 to fourth quarter of 2020 with more than 1200 positions now in this segment.
While increasing depth drove more growth than increasing breath during the pandemic, we see the continuing growth trend for both depth and breadth is encouraging markers of product uptake.
Can you to believe that driving growth in both depth and breadth is important and focused promotional efforts against this objective.
In a few moments I'll provide some closing remarks, but I will first turn the call over to our CFO Keith called in for comments regarding fourth quarter 2020 results and perspectives regarding our corporate guidance Keith.
Thank you Peter and thanks to everybody for joining us this morning.
Turning to slide 11.
As we reported up to nose recognized $15 $6 million of accounts net revenue in the fourth quarter of 2020.
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 <unk> prescriptions dispensed in the quarter.
We continue to believe this is a useful metric to evaluate the net revenues generated per prescription. However, we remind you that this metric is subject to variability that does not necessarily reflect a change in the price that is paid for an individual unit of a chance.
Based on available prescription data purchased from third parties and also on data that we receive from our preferred pharmacy network.
<unk> average net revenue per prescription for the fourth quarter of 2020 was $211.
For the full year of 2020.
<unk> average net revenue per prescription was $185.
This is a decrease of 6% compared to the full year 2019 average of $198.
Debt year over year decrease can work largely be attributed to the assist copay program that was an important initiative in the second quarter of 2020 ended helping patients during the early stages of the pandemic when other treatment options such as elective surgeries were severely limited.
Number we're not simply not available.
While this initiative did not I'm, sorry, well this initiative did support new prescription share growth amid unprecedented disruption in our customers' practices. The termination of assist is one factor supporting our projection of higher net revenue per prescription in 2021.
Moving to slide 12.
Ofer.
Our full year operating expenses defined as sales general and administrative expenses plus research and development increased by just 3% from $125 million from 2000 $19 million to $129 million from 2020.
In the same period <unk> net revenue increased nearly 60%.
The disparity between these two growth rates illustrates that <unk> net revenues Asics, hence net revenues increase we can generate operating leverage in particular from our commercial infrastructure and corporate overhead.
Full year, 2020 research and development expenses increased to $6 million for 12% compared to full year 2019 and drove most of the 2020 total operating expense increase.
Increase in R&D was primarily driven by ongoing conduct of our clinical trials.
Full year 2020 sales.
General and administrative expenses increased $1 $3 million or 1% compared to full year 2019.
The increase in SG&A was driven primarily by increased fees paid to <unk> as a result of increased volumes.
And by increased expenses associated with the annualized nation of the April 2019 expansion of our sales force.
These increased expenses were largely offset by expense reductions and delays in response to the COVID-19 pandemic.
Moving to slide 13.
Today, we announced our first quarter and full year 2020, 'twenty one financial guidance.
First we expect net revenues to exceed $80 million for the full year 2021.
Earlier, Peter described several factors that we believe have potential to accelerate <unk> net revenue growth in 2021.
However, we are providing providing a floor for revenue guidance to start the year to reflect uncertainty regarding the return of business conditions to pre pandemic norms.
Second as part of our expectation for full year 2021, we anticipate that first quarter 2021 expense net revenue will decrease compared to fourth quarter 2020 expense net revenues of $15 $6 million.
This reflects the same pattern of calendar effect on <unk> revenue as we reported last year.
The primary driver for this sequential decrease for revenues in the first quarter 2021 is there expectation that Q1, 2021 average <unk> net revenue per prescription will be between 120 and $140.
Third as we've seen in prior years, we expect <unk> net revenue per prescription to improve substantially for the remaining three quarters of 2021 over the first quarter.
The cadence for example for net revenue per prescription is driven by two effects that we believe are common for chronic treatments in our industry.
And that we highlighted last year as well.
The first factor relates to patient insurance deductible resets that occur in January.
A second factor contributing to this decrease is the delay or loss of refill prescriptions by patients, whose insurance coverage changed with the new year.
What is important to note is that the major factors that influence our gross to net deductions have not experienced substantial changes relative to 2020.
Overall market access, which drive rebates is generally consistent and the terms of our co pay assistance program will result in similar levels of patient support in 2021.
Fourth with respect to expense net revenue per prescription, we expect full year 2021 to increase compared to full year 2020.
As discussed earlier, we do not expect to repeat the pandemic response to assist program. This year and its termination is expected to increase six hence 2021 net revenue per prescription compared to full year 2020 results.
Moving on to operating expenses, our initial guidance for 2021 includes increases associated with key commercial and development initiatives.
These include fees paid to preferred pharmacy network partners and other distribution fees that are linked to increased <unk> prescription volumes as well as the conduct of our chronic sinusitis clinical trials as we pushed towards completion of enrollment.
For the full year of 2021, we expect total operating expenses to be in the range from $137 million to $142 million of which approximately $11 million is stock based compensation.
Total operating expenses, excluding stock based compensation are expected to be in the range from $126 million to $131 million.
I will now turn the call over to Rami to discuss our development programs.
Great. Thank you Keith turning to slide 15.
We believe our chronic sinusitis program as a potential driver of significant growth for three reasons for.
Chronic sinusitis is a high prevalence high morbidity disease affecting over 10% of the U S adult population and for which there are no approved drug treatments.
Second for limitations of current treatments have left high levels of patient suffering as measured by class a quality of life. Despite society investing up to $13 billion in direct health care costs from suffering over $20 billion in lost work productivity. According to a 2017 study of health care economics and chronic rhinosinusitis.
Third we believe chronic sinusitis effects not only many more patients for nasal polyps alone, but <unk> is also recognized in treated by a much larger universe of physicians, creating greatly expanded potential for promotion to people who may benefit from the product.
Within our current specialty physician target audience. This new indication could triple the number of patients for whom we can ask for business promotional Lee from approximately $1 2 million to $3 5 million patients.
In addition, physicians outside our current specialty audience treat an incremental six to 7 million patients further increasing the potential patient pool, such that it goes from approximately $1 2 million towards much as approximately $10 million.
Furthermore, evidence suggests that an additional 20 million people suffering from symptoms of chronic sinusitis have lapsed and no longer seek regular care for their disease. We believe this is often due to a belief that there are no new options for that physicians can offer a little beyond what has already been tried for those patients.
Our research suggests that many of these 20 million sufferers can be activated by a consumer directed promotion.
When we are able to offer a prescription option that is approved for treatment of chronic sinusitis.
Lastly, regarding the business potential for this new indication, we believe that successful development in CFS can create significant leverage of our existing commercial infrastructure and access to non dilutive capital to our primary care partnership.
We look forward to providing more updates regarding this program and the increased market potential that would facilitate as we close in on topline data.
Moving to slide 16 rigs.
Regarding that data today, we announced that we expect topline results from one of the pivotal CF trials by the end of this year 2021 with the results of the second ongoing trial not expected until the first half of 2022.
This is slower than our previously communicated expectation and that is a result of the global pandemic, which has had a sustained negative effect on patient ability to visit and be enrolled at trial sites in many countries.
Our regulatory and development teams have performed admirably in the environment created by COVID-19, identifying and opening new trial sites in places for local pandemic conditions permitted and supporting changes to local clinical and regulatory situations as they evolved through the course of the year.
We acknowledge that there is continued recruitment risk related to the COVID-19 influence on trial sites worldwide. However, we remain focused on producing top line data from at least one trial by the end of this year of 2021, and we believe this objective is achievable.
As a reminder, both trials have co primary endpoints one is a measure of patient reported symptom relief at week four and the other is a measure of effect inside the sinus cavities at week 24.
Also as a reminder, our development program for <unk> as a treatment for nasal polyps produced open label data measuring symptom relief in patients diagnosed with chronic rhinosinusitis, both with and without nasal polyps.
Numerically the symptom improvements from baseline for both of those groups were similar.
Moving to slide 17.
Changing gears I'd like to make a few comments about our development product Opn 019 <unk>.
We believe that our Opn open nine product candidate could have utility in the current pandemic and also has potential to improve preparedness for the next pandemic.
As a reminder, <unk> uses our proprietary exploration delivery system device to thoroughly coat, the deep nasal cavity, including the highest part for sense of smell as affected with an antiseptic that kills the COVID-19 virus.
This is intended to help prevent somewhat exposed to the virus from becoming sick to reduce the spread of the virus from an infected person to other people and to reduce progression of disease in people with early symptoms, who do not yet have symptoms or who do not yet have symptoms.
Previously we reported developing a candidate broad spectrum antiseptic formulation intended to be effective against any corona virus variant.
We.
Reported having performed in vitro testing against the Sars Covid, two with that candidate formulation and demonstrated a for log reduction in virus count.
In addition, we found broad activity against multiple other viruses with that formulation.
These results were expected based on previous knowledge, but were necessary to support moving ahead.
Today, we announced that we will conduct a pilot proof of concept clinical trial with <unk> to produce initial human data.
The study will be a randomized adaptive single dose study to evaluate change in viral load after <unk> in adults with COVID-19.
Assessments will include reduction in viral load by quantitative reverse transcription PCR and in the number of infectious viral particles determined by viral culture.
Evidence suggests reduction an intranasal viral load as we are measuring in this study is a useful indicator of potential ability to both reduce transmission of the disease and to reduce progression of the disease.
The study is expected to start in April and as short in duration. We therefore expect top line results within the second quarter of 2021.
We believe the development of therapeutics for patients diagnosed with COVID-19 or at high risk of exposure to the virus remains a high priority.
As a reminder, COVID-19 is the third pandemic potential corona virus to make a breakout just since the year 2000, and everyone knows today that the Corona virus continues to mutate.
Moreover, pandemic influenza has been and remains a threat.
Vaccines are extremely important but need to be supplemented by a range of therapeutics and we believe that a virus agnostic therapeutic such as <unk> nine that is easy to use by simple outpatient prescription could be an important addition to the therapeutic Arsenal for COVID-19 and for future Pandemics.
As excited as we and others are by the potential value of <unk> 109, our organizational focus remains on growing ex hands and on building, a leading E&P and allergy company.
Accordingly, we are committed to supporting the less expensive initial stages of this development program within our current operating expense plan, but anticipate that grants partnerships or other sources of capital will support further development of <unk> hundred nine.
I'd now like to turn the call back over to Peter for closing remarks Peter.
Thanks Bonnie.
Turning to slide 19.
Before moving to Q&A I'll take a moment to reiterate that I am incredibly proud of the effort and results for the team produced in 2020.
The global pandemic presented the challenges that are unique compared to what most of us are faced in our lifetime.
And our outlook for 2021.
We are trying to present a balanced view.
We assume that business conditions, while improving will not immediately return to pre pandemic norms with the available to get vaccines at the same time. We are optimistic for 2021 has potential to include a substantial improvement in business conditions and there are several factors that can increase the growth of our business.
We're laser focused on two very clear objectives.
Revenue growth for a chance.
And completion of our trials in chronic sinusitis.
Look forward to providing updates on our progress in 2021.
And with that we'll now open the call up for Q&A.
Thank you.
Ladies and gentlemen, if you have.
Question at this time please press the star followed by the number one key on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.
Our first question comes from Randall <unk> from RBC capital markets. Your line is now open.
Yeah, Great guys, Hey, this is Steve on for Randall Thanks for taking our questions here just just to for for me all of that from both upfront, but olive guide. Realizing you guys are providing a floor of $80 million and yes, it's still pretty substantial growth over 2020, but it's still a little bit less than even what the strength was kind of modeling for 2021.
I was just kind of curious if you can add some color as to what's giving you confidence that you're going to able to achieve at least $80 million and maybe some of the tailwind you're looking at can provide upside there and then just secondly on the <unk> trials, just maybe any updates on green guys arent enrollment status and when you're expecting to have therefore enrolled I appreciate the questions.
Yes, Steve Thanks, very much for the question and I'll take the first one longwall me I'll, let you or Keith handle the second one.
We decided to approach our revenue guidance with the concept of a floor and the reason for that is just because of some of the uncertainty that still remains relative to the pandemic.
So that was the approach relative to the concept of a floor. So what's assumed in that $80 million about the market environment is that we have we obviously have an understanding of the current impact of the market environment. Currently we expect some improvement through <unk>.
And then for the back half of the year, we expect the market to be reasonably returning to pre pandemic norms in terms of what is normally seen relative to patient volumes, because obviously the impact of the market environment has two impacts it affects patient volumes and physician offices. It also affects our ability to access was low.
So I'm, describing the market environment, because that's what's embedded.
In the assumptions around our ability to achieve this floor of $80 million.
Now what what creates optimism for us as we think about 2021 is we really do have as I mentioned, a couple of drivers that could create an acceleration of our trend and by the way I should say that in the $80 million floor. We assume the market that I described we also did not assume a dramatic acceleration.
And our ability to drive new prescription growth, which is clearly obviously our focus right now on.
And relative to our ability to accelerate prescriptions. We think there are two things that have real possibility of driving acceleration. The first is <unk> that I think everyone is very familiar with and the second is as I mentioned in my remarks, increasing recognition in the medical community of what we're calling a stepped care paradigm and importantly recognition.
And the cash is playing an important role in that step per treatment paradigm theres been some societies that have already introduced this concept of a step care paradigms and frankly, we expect more.
As we looked at 2021.
So with that Keith I know, if you have anything to add one or object relative to the $80 million.
No Peter I think you summarized it pretty well you know I'll comment on the second part of.
Steve's question with respect to the timing of of CFS.
If you go back to I think it was slide 16, Steve where we kind of lay out the wood wood a patient journey looks like in the trial from randomization to.
Two final visit is 24 weeks. So you can back up now if were announced.
Setting the expectation of having topline data by year end, you could expect us to be enrolling kind of last patient first visit around the middle of the year. So.
It's all going to say on that right now, but you can expect us to probably report out once we have that last patient for.
First visit to set the more definitive expectation of of when we expect that to have that top line data.
<unk>.
Steve I don't know if its helpful to you, but I can tell you that we have we've gone to great lengths to add additional trial sites and.
And we've tried to predict which countries will be able to inc.
Gage in inpatient enrollment, even some that were not able to do so previously a lot of Commonwealth countries are vaccinating a lot of clinics that were not previously able to to enroll because resources were diverted to COVID-19 care are beginning to be able to divert resources. So we.
We expect an uptick in enrollment as the as the first half of the year goes on and as Keith was talking about.
And so we are projecting to be able to complete the topline report.
As we as we guided.
Great guys I appreciate the color.
Thank you.
Our next question comes from Gary Nachman from BMO capital markets. Your line is open.
Hi, guys good morning for.
First just your share gains in the face of a declining category, whereas most of that been coming from and what do you think is a reasonable target off of the five 1% of your target physicians that you are currently at I think in the fourth quarter.
And then for Rami.
What portion of our exits are currently off label.
<unk> being used for CFS and any concerns with the quality of the data coming out of the clinical trial sites now that you've been adapting through the pandemic and then I have one other follow up.
Gary Thanks for the question I'll, let <unk>, our Chief commercial officer take your question on share and then Rami can address your second question.
Sure Peter Hey, Gary Thanks for that question I mean, I think the key point is that we saw our share gains come from really two areas one is increasing.
Use from our existing prescribers and I think Peter described that has the depth of prescribing that was the biggest driver of our growth and just reflects the difficulty of the market and getting in front of new potential customers during the pandemic.
The second is breath, we continued to grow and bring new people into the franchise last year and frankly, we expect to the ability to reach even more prescribers is depend on what kind of lift.
But to the point you made success, we saw in growing share last year, we do believe Inc.
And as we head into 2021.
Perhaps you can also comment on on Gary's question about the proportion of prescriptions that are for CFS versus N P.
Yeah, we continue to see that you know a nasal polyps represent I think about a third of our business overall and thats prescriptions that are specifically coded for nasal polyps you know a lot of times prescriptions aren't specifically quoted and so we pick up prescriptions from patients that have.
Either chronic rhinosinusitis.
Vacation or an allergic rhinitis and vacation, obviously I should note that those are not that's not business that we're proactively pursuing we do focus explicitly on nasal polyps, but we do see us outside of the nasal polyp indication.
Gary by the way I think I know this is well understood, but I still want to emphasize it that the the greatest value of the CF indication is not only potentially increasing the ability to drive the business in the E&P allergy segment. The real benefit is expansion to a significantly broader physician audience treating reason.
Really double the number of patients currently being treated and the anti allergy segment.
I know, that's reasonably well known but I want to continue to emphasize it relative to the value that the C. S. Indications, we think will provide to the business from.
I'll now turn it for you on Gary's question on quality alright. Thank you so.
Gary one last comment on the CS versus N P, which is it's the best data that we have available.
But I personally.
I'm not sure that it's high quality data about exactly which a diagnosis underlies the prescribing of the product.
I don't know that the incentives for accurate reporting are strong and I'm also a little bit skeptical about weather.
Sort of complete diagnostic maneuvers are completed for all the patients that received this kind of prescriptions. So I think theres reason to be a little bit skeptical about the accuracy of the categorization of diagnosis.
Category.
Your other question was about data quality in the trials. It's a good question, it's appropriate to ask in the Covid environment.
There were a lot of changes FDA and EMA and other regulatory authorities.
Issued new guidance on how to manage patients who are unable to make visits there was a lot of adaptation required we have been our clinical team has been just extremely careful about implementation of those kinds of changes and we're highly focused on the quality of the data that's coming in.
And we're very sensitive to the fact that this is not all just about completing the trial, but its about a positive trial at the end and giving ourselves the best opportunity to have a positive trial should the product in fact to be effective for this disease. So.
So we're very sensitive to it we have many measures in place to try to assure the data quality and ensure the right kind of patients are continued to be enrolled despite some of the changed.
For the pressures on the trial sites and non patients.
Hey, Gary I will I will add one comment on share you asked us to project share and we're not going to specifically give guidance relative to share for this year, but again I want to remind.
The listeners that all of the work that we've done historically and we just refreshed with physicians relative to the potential of the product in the market in the E&P and allergy segment alone before I can talk about expansion into primary care suggests that we believe continue to believe very strongly that the peak share for.
This product is in the 20% to 30% range.
We're already achieving that the confidence of why we have confidence in that number as we've achieved that in this believer segment that we're currently calling on so once we turn someone into understanding the efficacy of the product understanding that our market access and coverage really is very strong.
We achieved shares in excess of 30%. So I just wanted to remind as I said, we're not giving specific guidance for this year, we remain very confident in our ability to build a substantial business.
Okay. That's helpful. And then just one quick follow up the increase in the target physician audience to 18000 from 10000, that's all an anti allergy and just how much of that is coming from <unk> versus your own sales reps and just remind us how many reps you have and how many <unk> have.
Going after that target audience.
Yes, I'll, let Nick take that Nick go ahead.
Yeah. Thanks for that Gary I mean, so we have <unk>, calling on up to about another 3000 additional targets and so that 3000 is included in net and that revised number.
The rest of the number comes from the expansion of.
Our targets for the rest of the E&P and allergy universe that are using <unk>.
Basically learned that those are opportunities for us to grow the business and our focus there as well. So we think this new expanded denominator. If you will it gives us a better representation of how broadly.
Thanks.
In the segment.
So as.
Perhaps a little bit beyond the question you asked areas. So roughly half of the <unk> effort is coming from targets that we don't reach the other half increases on frequency.
Of activity against targets, we do reach but simply not as often as we would like to believe we can productively each of them.
And so that gives us a chance to use the benefit of their relationships both to extend the breadth and the depth of our engagement with customers. Our sales teams are roughly about the same size, we have about 100 people.
In the opt in those Oh.
Our sales team and we have about 100.
Within the <unk> team as well.
And Gary just to make sure it's really clear I think Nick answered that very well, but so our 100 reps call on about 10000 physicians largely E&P and allergy with some primary care light against specialists like primary care <unk> has about 100 reps theyre targeting 6000 physicians 3000 that are overlapped with our 10000 roughly 3000.
That are nominal.
Gross.
Okay got it that's helpful. Thank you.
Thank you.
Our next question comes from Brandon Folkes from Cantor Fitzgerald. Your line is open.
Hi, Thanks for my questions and I appreciate the guidance as well in this current environment.
Maybe just tossing day and yes.
Paul I appreciate the commentary on <unk> guidance.
I heard the comments about two QB seeing some improvement.
But can you just maybe talk about.
What do you see.
Envision or price.
Keeping that we exit the year at just I, just want to make sure I kind of thinking about 2021 that ramp.
Property, just given that it seems to be what we're implying here with a strong second half of the year, yeah, we exiting at a pretty solid growth rate as well. So I just wanted to get ahead of ourselves. There and then secondly can we just talk a little bit more about the net price per script. It seemed to come down from three two for cute.
So maybe can you just one any inventory in the channel at year end, we should consider for <unk> and then secondly can you remind us of the dynamic was to layer and how we should think about net price per script in 2021 pad with clarity is that gonna be ebay.
A small dilution day, we should think about in terms of what you're gonna realized thank you.
Keith I'll, let you take all three of those.
So the guidance with respect to exiting the year and the velocity at the end.
For Q4 expected Q4.
Because those closely velocity I think Peter summarized in his comments to the first question about the.
Assumptions around what drove.
Or.
What drove us to guide to an $80 million floor for this year.
And what are you spoke about the potential upsides I think that kind of summarized our thinking we.
The second surge of.
The virus late last year definitely lasted into the first part of this year.
Obviously seen that received today, but our assumptions drove a or our assumptions were that the first part of this year, we're going to see significant adverse effect.
With respect to a.
The patient volume.
Going into the physician offices and B, our reps abilities to access those offices I think our reps are doing.
From a phenomenal job in the field in terms of the face to face interactions that theyre getting on a daily basis, but the fact remains that.
Net they are not able to access a large percentage of their target customers.
We see that easing.
While we see those those limitations easing as we move throughout the year. So we definitely see a an uptick or a an.
An increase in velocity as we as we progress throughout the year, and then I'll kind of tie that in with average net revenue per prescription Brandon.
Similar to other years you heard in my remarks, we expect to begin the year at a lower average net revenue per prescription and then accelerate that as we.
As we progress throughout the year as we've discussed that's really driven largely by a.
A good.
Commercial coverage.
The good commercial coverage that we have today enables us to offer a pretty generous coupon program.
To buy down patients' out of pocket expenses in the beginning of the year as patients.
Have deductibles reset whether they are in a traditional PPO plan or a high deductible plan you know they are out of pocket maximums or high deductibles.
In the beginning of the year our contribution to those patients is larger and that affects our average net revenue per prescription in a negative way.
And we guided today that we believe that the first quarter would be similar to the first quarter. We saw last year in the range of 120 to 140 <unk>.
Per prescription.
Again throughout the year as patients meet those out of pocket deductibles.
We contribute less to the coupon program, we don't have to buy down as much out of pocket expense and that positively impacts from net our average net revenue per prescription.
For Colo Vik just.
Kind of bifurcated for you the two different segments of our customers. The Clio is calling on and we have a different.
Model two two.
To pay for the work the effort that we're getting from cloud and segment one those are the.
Positions that we do not call on.
So close clearly given us additional breath on targets that we think have the ability to drive <unk> volume.
On those segment one targets collect we're paying <unk> a.
It's a it's an eat what you kill model. If you will we're paying them on a per prescription generated basis, it's very easy to tell.
We can identify prescriptions and link them directly to a to a physician so and those physicians out there calling on that we do not write a script.
<unk>.
Remunerated for that segment too, where we have our reps, calling on a position and clay will also close on that position.
As Vic said earlier, we're getting additional depth or additional reach I'm, sorry additional frequency on those targets.
There, it's almost like a CSO model were.
Pain for activity. So we are paying for a second position detail. We have an agreed upon rate that I would say it was.
As market for CSO, but the quality of the relationships that the <unk> reps have with these physicians is much much deeper than we would expect to see from a typical CSO type of relationship.
Colorado reps had been calling on these physicians many in many instances for many years.
And we're getting a very high quality second detail based on those deep relationships for what we would pay for a typical CSO contract.
And Brandon just to sort of get just circle all the way back to your question on the impact on our average net revenue per prescription the second piece of what Keith just talked about as a marketing expense. So it doesn't even show up at all the fee that we're paying for.
The CSO type arrangement and the first segment that Keith described mark for paying a.
The fee per prescription.
<unk>.
It's just not going to be material to affect ASP, our ASP or average net revenue.
It won't affect <unk>.
Correct.
Yes. So we just we remain very confident as we guided that the 2021 average net revenue per prescription will look a lot more like 2019 and 2020.
Okay. That's very helpful and I appreciate the color can I just squeeze in one more from me I.
So in August but.
Okay.
It's been quiet and awareness in the prescribing community you call on right now about the C. S data granted you're obviously not going to be able to promote off label.
But I'm just trying to get a concept.
When it comes out when do we see the one trial come off this year do you think there's enough of an awareness debt needs position may increase.
Off label usage should that day to be positive. Thank you.
Yeah, I think I'll, let you take that.
Yeah happy to comment on that so we would expect there to be increasing awareness of the data as it goes out into the public news to your point, obviously, we won't be promoting it.
But we expect given that there are no approved drugs in this space if it will be attention and.
Awareness of it.
And to the community if you will as soon as that data becomes publicly available to your point.
Physicians are already aware that nasal polyps occurs and pipeline for sinusitis patients.
Certainly they are aware that they are treating.
Anti inflammatory drug subs.
The subset of patients already have Crs, we think this new data is going to add confidence for cause.
The increased use.
Great. Thanks very much.
So.
Thank you. Our next question comes from David <unk> from Piper Sandler Your line is open.
Thanks.
Wanted to ask a hypothetical here regarding.
The CNS data.
So to the extent that.
You show a benefit versus placebo on symptoms.
But do not on the objective measure, which is sort of I guess uncharted territory in terms of a big randomized trial in terms of that endpoint.
Do you still envision.
That kind of result, with that kind of result, do you still envision.
Significant expansion of the overall.
Hence.
Opportunity.
In that in that scenario, that's number one and then number two to the extent that you Delphi.
Our co promotion partner here until the extent that you go it alone in terms of sales force expansion, how should we think about the extent that that sales force expansion in terms of in terms of head count.
How much larger would you go in other words thanks.
Well, maybe I'll start and Rami you can add some color commentary on.
David's first hypothetical and.
Obviously, David we've done and Rami mentioned this.
Team did a lot of work to understand whats necessary to define how we measure the objective criteria of the postal thickening in the sciences designed the trial to make sure we were sort of getting the right population.
And I think you know we have evidence already that if.
If we have the right population that has enough disease, we have evidence that we can improve scan.
So while it is unchartered territory I just want to make the point that we feel really pretty good about our ability to have success, there I'm going to always give the caveat that with the trial never necessarily know the outcome relative to your question, though on a.
I'll reiterate I think what's implicit in your question on <unk>.
David is that because we studied a large population of.
Patients, who have quantified science scientist without polyps, which is the obviously the population we're studying in the CF trials in our open label trials and we did look at improvement in symptoms, we really have pretty good evidence that it's really.
Likely that we're going to see an improvement in symptoms.
So relative to your question in that hypothetical scenario.
We still think there is benefit for the business because this would be the first product ever to show improvement in symptoms in a chronic sinusitis broad population. So theres value purely in the fact that when would be the first product to show that benefit from symptoms.
The ability to weather.
Whether or not we could turn that into a label is not clear, but I'll emphasize a point that we make a fair amount, which is there is no product approved in the CFS population at all.
So while it's not clear at all whether we would be able to get an indication that was based on a symptom only improvement.
Theres certainly has the potential of debt, so I'll sort of start by describing that and that therefore could then lead to the same kind of expansion that we expect if we have positive outcomes in both endpoints. So I'll stop there and Rami, let you add any additional color before I take David second question.
So David we did contemplate this possibility and the design of the trials.
There are two co primary endpoints as we've mentioned before.
But they are designed in a step down procedure and we have chosen symptoms as the first.
Step, which means that if symptoms are positive for the trial is positive and then the full sort of P value space.
Space gets passed onto to the Cte scan data.
It is conceivable that we will have positive trials on the basis of symptoms, even if they don't turn out to be positive on the basis of that of that C. T scan measure, it's uncertain, whether or not trials of that type.
Could result in an FDA approval for an indication.
That's something that we would have to take up with FDA and so I can't.
Guests for how that how that might come out, but as Peter said, we're not aware that any other product has had that kind of.
Large sort of regulatory quality.
Sort of confirmed trial support for efficacy in this population.
And given the desire to practice evidence based medicine and the potential for adoption of the product in treatment guidelines.
And another sort of places that help to direct medical practice.
Think it's reasonable to suspect that there could be substantial adoption for that use on the basis of that kind of evidence.
So David I'll take your second question on.
What if that.
Product does not get partnered and <unk>.
I know, that's all hypothetical, but again I'm going to sort of emphasize why we think there is really reasonable probability of a partner being interested in this product.
ZIP code Ali just refreshed research that we've done historically on the value of the <unk> indication in the sort of broader universe of primary care providers in the full opportunity is expansion to roughly 60000 primary care providers. So we've just refreshed the market research that we've done historically and there really is a very substantial.
<unk>.
In that population and that's probably just the patients who are currently being treated in physician offices. So.
When you put that concept together with the idea of enabling a direct to consumer campaign to address the roughly 20 million people who are lapsed. So as a reminder, 30 million people have chronic sinusitis 10 million being actively treated that we believe this indication will enable expansion from roughly two and a half to 3 million patients that.
E&P allergy universe to roughly 7 million who are in the up in the primary care universe, but potentially the greatest lever from the <unk> indication is the direct to consumer.
And it's very clear from the work we've done that while patients have lapsed from physician care, it's not because of they're no longer suffering they've just sort of given up relative to options that are available. We think our messaging is very simple. So I just wanted to emphasize.
Put that all together and we really do believe the opportunity is very substantial in.
In the primary care space, we think that's going to be attractive to a number of partners in this space, but now to specifically and by the I'll say the last thing I'll say is this emergence of this step care paradigm.
And I think we're clear on what we mean by step care the idea of the experts in the treatment of this disease continuing to put out.
Guidance, if you will one out on an algorithm that says start with an intranasal spray. If you fail on an intranasal spray before going to surgery or other more invasive and types of things to potentially help.
It helped with the disease exhalation delivery system works and should be considered and potentially the greatest opportunity for that is in primary care because it gives a primary care doctor the option triangle enhance before referring into a specialist so.
That paradigm, continuing and we're seeing already the emergence of it we're going to continue to believe it's going to get broader and broader adoptive, which we think again makes the opportunity very substantial so now that answered your question.
If we are in a go it alone scenario, we would not go to 60000 physicians out of the gate with 500 additional primary care physicians are primary with our sales reps excuse me, but we would target at.
The most interesting part of that segment and a go it alone strategy and I'm not going to give specific numbers David but.
We would not go to the <unk>.
Somewhere in between where we are today in the 60000, we think would make sense and we do think would make sense for the go alone strategy to be broad enough in the coverage.
Go it alone strategy to be able to do DTC and I want to be clear DTC doesn't necessarily mean expensive broadcast we've learned a lot about how to do very smart targeted digital.
They're kind of you have anything to add for Keith or others.
I think that's I think that's a great summary, I mean, the only thing I'll add is we know that primary care physicians are the first stop for patients.
With Crs and so we do think reaching them is going to be important and we know from our research that they are very interested in having a product that they know can help this patient population. So we're going to find the ones that have sufficient volumes for these patients and and make them aware and are confident as how to integrate it into their practice.
Okay. That's helpful. Thanks, guys.
Thank you. Our next question comes from George <unk> from Cowen <unk> Company. Your line is open.
Yes.
Hey, Thank you for taking our questions.
Just for you I guess for US can you talk about the current patient assistance program.
How that has changed.
And I guess related to that where do you stand with managed care coverage for <unk> and.
What is the average out of pocket costs for patients and can you describe the temperature requirements is it just a simple failure of intranasal steroids are the patients need to fail.
Multiple therapies and based on your market research what percentage of patients failed therapies.
Jack I'll, let you take all of those.
Happy to do that so, Georgia, I'm going to start with your questions about the coverage we have about 77% commercial coverage today, we're really pleased with that coverage and in fact for payers who have added expands into their formularies are in fact seeing the benefits in terms of their ability to improve the management of these patients and frankly improve their expenses.
Two if they are able to you know to be thoughtful about which patients are then referred on for later line more expensive therapeutic solution.
Or even surgical solutions as well.
And we see that creating pressure in an opportunity for other payers to continue to watch the attic Sampson their formulary. So we're really pleased with that formulary coverage.
Your second question is around the changes to the co pay.
Portability program that we have in effect traditionally what we had is we had a zero dollar for prescription for commercially covered patients.
And if the patient was uncovered they've received the force prescription for zero for the second prescription for $50 and all subsequent prescriptions for $50.
And then in effect, what we changed is B E.
First prescription payment from a patient is now $25. If they have no commercial insurance coverage. So if you think about the percentage of our commercial lives that are uncovered paid $25 for that for prescription and 50 for subsequent prescriptions after that.
And that's important for two reasons one is it effectively changed the jump in their co pay for.
Prescription for the refills instead of going from zero to 50, we found it's just easier for them if they paid $25 per prescription.
Moving to $50 for the second prescription and frankly, it make sure that.
You know that we're effectively getting as many profitable prescriptions as we can from that pool.
They should.
You had a third question, there and I'm sorry I.
Could you just a reminder, I'll jump in I think it was about the average out of pocket and we have a lot of data on this and nationally.
Protein, 80% of patients paid zero out of pocket for our product.
No.
Roughly 5% to 6% pay the 25 or $30 and the balance pay the $50 to pick was describing.
Commercial.
In the commercial population, which is the huge majority of patients in the product. So by the way it's indicative of the coverage. We have we really do have good market access coverage.
And the last point I'll make in our access by the way we do a lot of research among our believer segment and our Dabbler segment and it's very interesting. If you ask the believers not only do they believe in the efficacy of the product to a high degree. They also say that the product is actually reasonably easy to write in terms of everything that's required.
<unk> on the backend prescribing it any prior authorizations any step therapy, that's required and it's interesting because that group is writing a substantial number of prescriptions. So if it were in fact hard that.
That group arguably would be the group that would be believing it's the coverage may not be net good for that group believes our coverage is good.
Interestingly in the Dabbler segment.
We learned one of the key things we have to get them to understand is our coverage. In addition to having more of a belief in the efficacy of the product in the.
The reason I just continue to have high confidence in the 20% to 30% share for this business as the product really works and we do have good market access coverage.
You have to continue to come.
Convinced the dashboard if you will of the program so Nick I'll, let you finish.
Yeah. Thanks, Thanks for that Peter or the last part of Georgia as you asked about specifically what the.
The access looks like the vast majority of that commercial coverage that we do have that step through an inhaled nasal steroids. So either there is a history of an inhaled nasal steroid use for the physician documents or some inhaled nasal steroid that's been used.
And about 15% so that's a one 5% there.
Payers are asking for diagnosis codes. So they want to know that it's nasal polyps.
But for the most part they have to show that they do use day in inhaled mix.
Steroids before they get to experience.
That's really helpful. Thank you so much.
I guess, just a very quick.
On the net revenue per Rx I guess, if we.
You've kind of alluded to that but if we just ignore the 2020 and different <unk> do you expect net revenue per Rx growth.
Or I guess levels in 2021 to increase over the 2019 levels.
So George we're not we're not being specific.
As to what the growth looks like I think the 2000, if you recall in 2019, we achieved average net revenue per script for the full year of 198 I don't think.
Returning to those levels is certainly not out of the question.
We did take a small price increase this year.
About five 5%, we don't retain all of that obviously a lot of that goes to the channel partners.
But the.
The termination or the fact that we don't expect to be repeating the assist program. So its.
Should certainly give us some some tail winds.
From the 2020 level of 185.
Keith for last thing I'll add is the.
Convicted mentioned some changes in our co pay assistance program and that's also a tailwind because we are those are benefits in the profitability per script that we're receiving and we have pretty good confidence is not going to impact prescribing or volume.
That's great. Thank you so much really helpful.
Thank you.
Our last question comes from David Steinberg from Jefferies. Your line is open.
Thanks, and good morning.
You showed us Peter some slides with.
The universe of prescribers and breakdown of how many.
Prescription for it but the doctors, who wrote and so I had some.
Additional questions on physician prescribing behavior, particularly since the products now, but in the market for about three years.
The first question is the 10000 physicians that you've been targeting have all of them actually been called on at least one or you still are you still waiting to call and some of them and secondly.
What does the data shown in terms of typically how many how many calls need to be made before.
Actually write a script and then third and perhaps more importantly, it looks like of the 13000.
But you can't targeting.
About half have written one prescription so just curious.
Given that it's been on the market for three years why what are the reasons why half of it half of the doctors that you called on have not yet written a single script I mean, you've talked about.
Some of them don't realize the coverage or they don't believe in the efficacy, but after three years most of them really know that you do have good coverage and is there any other reasons why has it and it's still not written a prescription yet thanks.
Yeah.
Moving to call it and you take those.
Okay. It sounds great. So on your first question. They have all been called on you know, we're able to reach at least from pre pandemic world about 80% to 90% of all the target physicians, obviously, we would like to be able to reach more of them and certainly they have to get more challenging over the last year.
But we are able to reach them at least.
Once we do know to your second question that we obviously, reaching them once is not enough. We really believe you distribute share between seven to 10 times before we begin to impact their prescribing.
Prescribing potential and we do try and reach them and support our reach with them with the non personal promotion. So that we do try and reach them from a number of different angles, obviously, reaching them through our territory managers is a most effective way to grow with the prescription volume.
So your underlying question is what is it debt so holding some physicians back and it really is two things of course, they need to understand that.
In fact, it is you have an underlying disease etiology that is characterized by inflammation that's out of reach of the other solutions that they're using.
And secondly.
We need they need to get very comfortable that that they can get the prescription when they write it they need to use the preferred pharmacy network that we've developed.
And those are really the two key barriers once we can get them comfortable that in fact, that's you know that's a problem that they need to solve by getting a.
Topical treatment to the site of inflammation, that's causing the growth of nasal polyps.
And the second part of it is making sure that they understand the process for getting for.
For the authorized.
It does take US seven to 10 times before we really begin to move there.
The prescribing behavior.
But underneath it in 2020, we really changed our focus if you will from a sort of from a post surgical patients. So we were identifying patients based on their surgical status to expand out to a broader audience of patients who are appropriate for nasal polyps treatment.
And many of those patients don't have a formal nasal polyp diagnosis and so we're helping clinicians recognize those symptomatically.
That's enabled us to then expand the target universe from about 10000, net we were calling on that launch for about 15000 per day plus of course the.
The incremental ones that close, allowing us to reach you.
Do you have a number of factors.
Delivering it or if you will expanding our ability to activate those doctors and that's why we look at those both of those metrics are we getting more prescriptions from a physician thought we have activated and in fact, we do continue to grow that and the second part of it is are we still seeing a consistent growth of adding new doctors into the franchise and then.
The fact that we're still growing more breadth.
It makes us confident that we can continue to activate more doctors.
Clearly that's the part that got tougher.
Mike.
Good day, that's the point I'm trying to make is that in the market three years, yes, but you know we're about a year now in pandemic environment and pandemic.
Pandemic environment, just makes it hard to get to the physicians. These dabbler physicians, it's easier to get to doctors, who know us we know the product so relative to.
Called on universe in a pandemic environment.
It's frankly easy to get to the believers, it's harder to get to these tableau doctors. So again, while yes in the market three years, but one year with real constraints on our ability to reach physicians and we believe as the pandemic eases.
As we hopefully we all expect.
Our ability to get back to get doctors, writing, we're gonna be able to get that volume really moving because we do not see things in the way.
As I mentioned earlier in his believer segment, we have in excess of a 30% share stock.
Doctors are writing it very frequently in our view is that we are going to be able to expand that segment.
To move people up if you will from that Dabbler segment into the believer segment. The last point I'll make David and this is <unk>.
Drew I think than any product in today's world is that the the.
Payers frankly have created some real sand in the gears and we just got to work through that sand and.
Because we do have good coverage and I remain confident we're going to be able to work through that standard.
Okay. That's very helpful. Peter and Vic and then just two quick follow ups first where are you on refills I think at last check your over for Refills, and where do you think that those top out at and then I know over.
Over the last year, you've mentioned a few times that you are considering or looking at bringing in other assets. So your sales people have another product in the bag to detail the doctors.
Is your current thinking about business development.
Yes on refills, we remained very pleased with resale David and it's it's now over for.
In.
Where could that top out it's hard to predict but I think there's still room on refill rates to continue to move up principally be for one reason that the product works really well. We just continue to get very good feedback from patients who are using the product and by the way I think you'll recall that we did a program we called on the explorer program in 2012.
It was hurt somewhat of our ability to reach doctors because of the pandemic, but we have you know approaching another thousand patients debt.
We did put into this program when we got feedback from the patient on how well the product works not surprisingly the 80% to 90% of patients say the product works really well, we by the way are taking that data and feeding it back to doctors.
So I continue to believe there is room on refill.
Relative to expansion of.
The product.
It's very clear that you know.
As a single product company, we have to get leverage out of the organization. We don't feel we have a terrific sales team and so certainly in the next 12 months to 18 months, our aspiration is to no longer be a single product company.
And I'll also to stop there.
Okay.
Yeah.
Thank you.
And that does conclude our question and answer session for today's conference I'd now like to turn the call back over to Peter Miller for any closing remark.
Well I just thank you all for joining us we absolutely understand that we are in a in an environment, where we got to continue to put up strong results and thats our focus both in growing <unk> revenue and completing our trials. We're laser focused on that and we appreciate you joining us for the call. So with that we will end the call. Thanks very much.
Ladies and gentlemen. This concludes today's conference call. Thank you for your participation and you may now disconnect everyone have a wonderful day.
[music].
Okay.
Yes.
Yeah.