Q3 2022 Ardelyx Inc Earnings Call
Welcome to the R gel like 'twenty third quarter 2022 earnings conference call. My name is Sean there will be your operator for today's call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session if you'd like.
To ask a question you can do so by pressing zero, one and you touched on phones as there.
A reminder, this conference call is being recorded I will now turn the call over to Kim your cash part of our Dallas you may begin.
Thank you and good afternoon, everyone and welcome to our third quarter financial results call.
This call we will refer to the press release issued earlier today, which is available in the investors section of the company's website at our Delta Dot com.
On the call with me today are Justin Renz, Chief Financial Officer, and Susan Rodriguez, Chief commercial officer with prepared remarks.
Dr. Laura Williams, Chief Medical Officer, Dr. David Rosenbaum, Chief Development Officer, and Rosling, Chief Regulatory Affairs, and quality Assurance officer will join us for the question and answer period.
Our CEO , Mike Raab won't be on this call as he is doing was recovering from a recent surgery and will be back soon.
During this call we will be making forward looking statements that are subject to risks and uncertainties. Our actual results may differ materially from those described.
We encourage you to review our risk factors in our quarterly report on Form 10-Q filed today, which can also be found on our website at <unk> Dot com.
We may elect to update these forward looking statements in the future, we specifically disclaim any obligations to do so even if our views change with that let me pass the call over to Justin for opening remarks.
Thank you Kim and good afternoon, everyone.
It is with great pleasure that I provide you an update on our progress since our last call.
We are in a notable positioned to be a standalone drug innovator in the midst of course was <unk>.
First in class drug discovered and developed by our Delek and generating revenue, while advancing our pipeline.
We are now six months into watch and we're pleased to report that the ROE is resonating with prescribers and patients as an important new treatment option for Ibs C. We.
We are clearly gaining traction and building momentum in this marketplace.
These early days of giving us confidence that both patients and prescribers are embracing abroad.
Having a positive experience with the drug.
As we noted on our last call. We are seeing an excellent response to our sales and marketing efforts, where feedback indicate significant and growing enthusiasm for it as well.
We have an important upcoming regulatory milestone in two weeks when on November 16th.
Cardiovascular and renal Advisory Committee will review and discuss.
Our novel treatment for controlling serum phosphorus in adult patients with <unk> and <unk>.
Al.
We look forward to presenting our data and rationale for the committee and updating you afterwards.
Now turning to our Japanese partner, <unk> Corporation, or <unk> and their progress with Hyperpotassemia in Japan.
On Monday, we announced that <unk> has submitted a new drug application or NDA put snap on or to the Japanese ministry of health and welfare.
Accordingly, we strengthened our balance sheet with $35 million expected this quarter based upon this recent submission.
This is an exciting collaborative milestone achievement, which demonstrates our commitment to the program.
Reinforces the drug promise to address the needs of patients with Hyperpotassemia.
As Mike often common our Dallas is uniquely positioned as the final pharmaceutical industry is a company with a proven track record from an internally discovered therapeutic pipeline.
Dedicated tenacious and talented teams across the company.
Now I'd like to pass the call the Susan to provide more details on the building momentum Forbes Rolla and the important role play in the treatment of IBSA Susan.
Thanks to ask him.
Okay Alright.
<unk> is working we are gaining traction and are well positioned to continue to build market share neck.
I will review Margaret responds to the four core elements of our strategy critical to driving uptake.
And lastly, I will review, our judicious approach to investing in opportunities to accelerate future growth.
I've just been mentioned we are six months into our lives and I'm pleased to report that Israel is rapidly becoming established as an important new treatment for I V. S C.
Net product sales of his rella, where approximately 4.9 million for the second quarter of our lunch and nearly 7 million from one to the end of the third quarter of this year.
H P. P's are enthusiastically adopting a thriller because of its novel mechanism of action and robust clinical data.
Viewing of grella as an accessible new therapy and are integrating umbrella into the office practices. They have in place to manage specialty drugs.
Offices are submitting prior authorization and experiencing favorable approval rate since most of their patients had been treated with a limited option, which is the criteria in place across most hair.
Early reports of patient treatment experience had been positive driving interest and expanded used to the size of a pool of patients under their care, who continue to suffer with persistent symptoms. Despite treatment with a G C C <unk> or.
Our strategy is working.
When we announced the launch of if Gellar earlier. This year, we emphasize for core elements of our strategy that we're innovative and not seen before across the I V F C therapeutic space.
The strategy for design to disrupt the market with a novel first in class mechanism therapy and capitalize on the opportunity existing within what is now an established uncluttered Ivy F. B R X market with limited treatment options and are recognized on net patient need.
I will briefly review these card disruptive elements today and the results. We are seeing during the first six months of lunch that reflect growing market traction and our predictive of continued success.
The first element to our commercial strategy is to capitalize on the opportunity existing within the patient population currently under a doctor's care and treated for Ivy S. D.
This is a critical market dynamic for it indicate the potential to address an existing clinical need with a novel product offering with a promotional focus centred predominantly on treating H D. P.
This targeted focus enables the ability to access value from the existing Ivy S. C. R X market in contrast to the product is launched over the last decade and needed to build the market through heavy direct to consumer spend a.
Additionally, our market assessment informed us that hcp's considered IBSA <unk> to be a condition with a multifactorial pathophysiology and in this context view the therapeutic of Ivy S. C to be characterized by limited single mechanism treatment options.
They reported that due to the limited options many patients under their care continue to suffer with symptoms and we're in need of a different treatment approach.
All of these market insights are central to the potential for a novel mechanism agent like Zarrella and I am pleased to report that are on market experience has confirm these dynamics with our sales force now deployed for six months the spirit tracking resolves report that 60% of Acp's <unk> with a.
64 per cent overall awareness level.
90% of the Hcp's, who were aware of <unk> right. It is as in advance versus existing therapy 44 per cent of Hcp's identified themselves as a current prescriber with an additional 31% reporting intent to adopt within six months.
The second core element to our strategy is centered on access with a targeted approach focus on the clinical need amongst patients who've been treated with an existing therapy and need a different approach.
Successive our access strategy centres on two critical factors one recognition by H C. PS and payers that is <unk> address is an important clinical need as it works in a manner that is novel versus available branded options and to establishing a zarrella as a specialty drugs that could easily be integrated into Kurt.
Currently existing office procedures to secure prior authorization needed for patients to access therapy.
Six months into our launch payers have evaluated thriller and the policies. They have established enable a path to access <unk> on the basis that the patient has been treated with a limited treatment options and is in need of a different approach.
P. A approval rates, we see reflect the size of a subset of the treated population who meet these criteria in the office willingness to submit the prior authorization required to access it thriller.
The fact that the pool of IBSA patients currently under the care of high treating H P. Ts have typically been treated with an existing therapy combined with the HCP willingness to submit the prior authorization requests will continue to support a favorable patient access environment for thriller going forward.
Third our lunches centered on driving early experience at a thriller to establish it as a critical part of what is now an expanded ibs's the treatment armamentarium.
HCP experience with the early patients they are treated with Israel has been favorable reflected by positive refill right as well as the launch tracking report issued by spirits were 42% of Israeli users reported moderate satisfaction, which is a rating of 47 on a scale of 10 and 58% <unk>.
Reporting high satisfaction, which is a rating of eight to 10 on a scale of 10 a.
Additionally, current users projected that they're used would increase significantly over the next six months.
And of course, and quite notably we have achieved this drawn start with a targeted promotional approach not seen before in the I V. F. C C. But one that has proven to be highly viable given the established nature of the market today and the clinical need for new treatment options.
Promotions focus on Hcp's, managing a high volume of IBSA patience with demand not dependent on D. T C span and access not dependent on heavy payer rebating.
Additionally, we are achieving early uptake at a price of lines the clinical value proposition of Israel as those patients in need of a different approach have had no other options prior to the launch of Israel.
This regard jealous position in the market is unopposed.
Manford Zarella will be driven by a C. P adoption for those patients in clinical need of this burst in class novel mechanism drugs with a strong clinical data profile.
Going forward, we will continue to amplify our sales and marketing efforts capitalizing on the growing awareness and interest in Israel, the access or you're experiencing for in person rep engagement with offices, the favorable patient access environment and strong market momentum.
See all sorts of leverage this early user base to expand you see the sizable number of patients hcp's considered to be Kennedy <unk>, while continuing to grow awareness and cultivate new writers.
Our scientific and promotional presence at national regional and local level conferences will continue to grow our.
Comprehensive digital initiatives via medical platform, social platform electronic health record platform and Rep, driven communications will be further targeted and personalised as we leverage the increasingly informative HCP engagement data we have collected since lunch.
<unk> will continuously for your fresh including comprehensive opinion leader video vignettes that reflect the important role is roller has now expanded I B S. D treatment armamentarium based on their own clinical experience.
We will leverage digital format to deliver in person speaking events across multiple locations concurrently and.
In person Rep follow up will be further amplified by targeted emails with continuously refresh content capitalizing on the high open and engagement ways. We are seeing across are highly digitally engage targeted H C. P.
Are lots of Israel embodies all that is possible in this post COVID-19 environment, leveraging the power of focus in person engagement amplified by digital tactics to bring a first in class new therapy to address a recognized patient need to advance the overall clinical management of a common condition with.
Scientific innovation.
In summary, our first six months of lunch demonstrate strong market performance indicators of interest adoption access and favorable treatment experience our strategy is working <unk>.
<unk> is gaining traction with a strong foundation on market presence in place that is predictive of future market penetration revenue growth and company profitability.
We expect to further bolster this growth throughout prudent investments in to accelerate our future success.
I will now turn the call back to just to review our queue 320, 22 financial and to provide some closing remarks Justin.
Thank you Susan.
As of September 30th 2022, we have total cash cash equivalents, the short term exasperated at $90.6 million.
Mentioned.
Net product sales withdrawal, where approximately $4.9 million and we got a total revenue of approximately $500.
R&D expenses was $7.5 million for the third quarter of 2022.
Decrease of 16.2 million or 68.5% compared to $23.7 billion for the same quarter in 2021.
R&D expenses included non-cash stock compensation expense.
<unk> zero point $5 million and 0.7 billion Nicole just ended September 30th.
22 2021 prescribed.
The decrease in Orange your expenses is primarily the result.
<unk> studied costs as a result of the completion of be optimized study.
<unk> manufacturing expenses due to the capitalization coffee production withdrawal.
Inventory and lower expenses from research in general falling the significant reduction of our research function in the fourth quarter of 2021.
S G and a expenses or approximately $18.7 billion for the third quarter of 2022 decrease with a million dollars or 5.3% compared to $19.7 billion for the same quarter in 2021.
S G and a included non-cash dark compensation expense of approximately 1.4 million and $1.5 million in the quarters ended September 30th 2022 2021.
The decrease in SG&A was primarily due to a reduction both are ongoing expenditures as well as one time costs as a result of restructuring action. We carried out during the third quarter of 2021 offset by increased cost associated with the continuing commercial watch victrola during the third quarter of 2000 and.
22.
<unk> was $22.9 billion for 14 cents per share compared to $43.6 million or 42 cents per share for the same quarter in 2021.
It is very important for us to maintain a strong balance sheet and cash position.
We are pleased to have completed several important transaction this year.
<unk>.
First we refinanced our term won't get with solar capital and we are an interest only payment mode until April 2024.
As previously mentioned, we also amended R. K K C license agreement in April , which we followed up with a royal detail financing agreement with help you with your partners or itchy or in June .
Notably these combine transactions have provided significant nondilutive capital.
I mentioned earlier as a result of Casey's recent NDA submission in the fourth quarter, we will receive an aggregate of $35 million in milestone payments and paste payments associated with the April 2022 Amendment of the license agreement.
Moreover, we are eligible to receive additional payments from K K C. Following the potential pool vulgar N V. I, Fortunately I happen to work for the improvement of hyper fast between in Japan, which we expect to occur in the second half of 2023.
Under our agreement with Itchy are we received a 10 million dollar upfront payment in June of this year, we expect to receive an additional $5 million next year falling K K sees potentially C. A regulatory approval.
We also have an opportunity to receive an additional $5 million <unk> net sales in Japan exceed a certain annual charge it level in 2025.
In return.
You'll receive the royalty payments and commercial sales milestones and maybe come to the us under a revised agreements with K K C.
We will continue to pursue all efforts to strengthen our balance sheet exercise judicious cash management.
We remain confident in our ability to continue to fund our operations.
Before opening the call for questions I would like to again emphasize our progress. This is an exciting and transformational time for our dogs few companies computer our potential as an evolving commercial growth story with many opportunities ahead.
<unk> strategy is working the opportunity is significant we're gaining meaningful traction we have a clear line of sight to financial breakeven.
<unk>, we look forward to making the case for exposure.
Advisory Committee on November 16th.
We believe it is important to provide additional treatment options for patients.
Be on dialysis with hyper fast the payment.
Finally, I want to emphasize we remain committed.
Good stewards capital.
Forward to keeping you apprised of our progress.
Before we open the call to questions. We understand appreciate that you may be interested in details regarding the upcoming Advisory Committee meeting, but given the proximity to the meeting date, we are unable to provide additional information.
Presenting our data and rationale to the committee in two weeks and updating you afterwards.
With that so now turn the call to the operator operator.
Thank you we will now begin the question and answer session. If you have a question. Please press zero one on your Touchtone phone, if you're using a speaker phone you to pick up your chance at first before first thing any numbers once again, if you'd like to ask a question. Please press zero one.
On your Touchtone phone.
Our first question comes from your <unk> <unk> from Citigroup. Your line is now open.
Hey, Justin.
Obviously, I'm getting a lot of questions about the upcoming upcoming I know I know you probably can't say very much but Ah you're able to just factually say, whether this will be an outcome, where there'll be a yes no vote at the end of the day.
Or is it just going to be more.
Qualitative commentary.
Thank you golf for asking that question.
To our.
Regulatory raw.
Yes, you go you know obviously, we're not gonna speak the details about that but the questions.
And and discussion areas in the bowling questions will if they come will become two days before.
The <unk> the actual meeting so too.
Two business days.
Got it okay.
Right, well, let's turn to Israel in the lunch. So so can you give us some thoughts as far as the how do you think the cadence of the line She's Gonna go and.
The rescue.
Rest of the year and for 2023, you what what <unk>, what sort of revenue momentum are you are you expecting and what's gonna drive that thank you.
Sure. Thank you golf.
<unk>, our chief commercial.
Question.
Thank you for the question yeah. So.
Mentioned talking about our first six months of experience, we're seeing consistent grows the cross crib, a ninth growth profile gross both of new riders.
Uhm it increases amongst existing writers we have.
You know looking at the girls momentum reflected today, we expect it to continue and accelerate we're really not in a position to provide any guidance at this time beyond that we really need to see how things progressed through the end of the year.
Have a V forward towards giving you some guidance sometime in 2023.
Alright, thank you.
Thank you. Our next question comes from Laura Cheetah from Wedbush secure.
It is your line is now often.
Okay. Thanks, very much for taking the question and.
Best wishes to my Gonna help me recovery.
Like when I was getting a lot of questions just with respect to the upcoming advisory 20 panel maybe it is a little bit differently can you remind us. Some examples that have gone through the a P. R a process.
And which.
Resolution has been identified that did not require additional clinical studies is that something that you have any examples that you can point to there.
Thank you for asking our situation as you might imagine is somewhat unique and we really look forward to making our case.
To the AD com with our treatment data that we have compiled over the years as our you know.
Three zero program that was conducted by David Rosenbalm War Williams in our team.
Don't want to comment on and compare ourselves to prior.
Cause each situation is different and so I I don't think that'd be fair to do so again, we we'd prefer to not comment on other situations because we believe we're in a unique situation.
Okay understood I might ask one follow up <unk> meeting and saw some of the poster presentations, we have four to half an hour or two of Karen has any commentary just with respect to I guess kind of physician awareness. So around <unk> and just how is this possible.
Changed over the past couple of years.
Yeah. Thank you for asking more that's an excellent question I'm gonna turn that over to Susan to give an update on the recent experience with.
Yeah. Thanks for the question actually we with a very comprehensive clinical development program executed to support the N D. A for <unk> as a result, the presents we've had it all the medical meetings over the last several years.
<unk> with all of the treating nephrologist involved in our clinical programs presentation of our data as well as the launch of a a very comprehensive disease awareness campaign throughout.
2021.
We have a very high level of awareness of exposure across the country across the nephrology treating community.
Spirit data actually it's the spirits reports has been tracking the interest in novel mechanism drug for hyper fast the team out of the awareness level of exposure persistently over the last several years and the very last data point published I think it was second quarter 2022 reflects the persistent interest across the nephrology.
Treating community for a novel mechanism drugs for new options to address the significant challenges that they put forward in the management of Hypophosphatasia in a high level of awareness and interest and exposure. So so we are quite encouraged that the awareness and the support across with treating nephrology community Uhm is quite high.
And we will be prepared to be able to mobilize and and bring a close a forward in the in the event of a positive scenario, where we can bring it so the two patients.
<unk>.
Thank you. Our next question comes from Joseph Jones from calling the company. Your line is now okay.
Hi, there good evening and thank you for taking my questions maybe right to thriller.
In terms of patient numbers or you got a guy who is in terms of how many patients are on therapy or can you give us a general idea of what this revenue number represents in terms of patience on therapy and do you have a set of patients that are currently don't have done the referral process and they're just waiting to kind of go through the prior authorization and get therapy, and maybe what what's the size.
Population, if you can provide some information.
Sure.
Alright.
Could I have Justin.
No I was just gonna stay on the first part of your question Joe. Thank you for asking you, we're not gonna give specific guidance of numbers yet.
Too early for us to give you specific some guidance, but we will we were absolutely as a company compiling metrics regularly and trying to be in a position because to watch progressive and again, Susan can give you more examples of the progress we've made in our outreach in general, but I I <unk> to give specific.
Right away because we're only seven months into our watch, but we are really encouraged by what we see so far so what we're not going to give specifics yet, but I'm gonna give susan the opportunity to expand on that.
So what I can comment on his information that we have shared publicly as a part of our communication around the launch it is zarella and the opportunity for a thriller so it. It overall the script market for I V. S. C indicated drive is about 5 million script based on our assessment.
The unmet clinical need across the marketplace based on all of our American research, we see a path forward and believe it's quite a cheesable to achieve high single digit share physician at peak and everything that we're seeing in the first six months of lunch as I reported in my narrative in terms of interest adoption.
<unk> intent to expand use it is all in their path to access of course, you know further support that statement that we made it our lunch. So that's what I wanted to share with you.
Perfect and then I know in the prepared remarks, you mentioned that there was a proportion of physicians that indicated they would like to use over the next six months I guess, what is sort of the gating factor to them using it or is it just the patients coming in is it getting.
It's better reimbursement or what what's stopping them <unk>.
Morrow I'm gonna write a script versus you know kind of over the next several months.
Yes that what.
What we're seeing in terms of the whole adoption cycle again, just early for six months is is <unk> getting in you know just it's really just getting the story out our message is resonating quite effectively we we get a favorable response in interest to use umbrella there's time to work with the office required to make sure that they.
<unk> is a specialty drug to be able to be prepared to submit the <unk>. There's the initiation of the early patients are trying and we're kind of at the state right now where we have a nice user base, where we have gone through that process they'd have favorable treatment experience as I reported in the narrative. So now we are embarking on this <unk>.
<unk> face for the product timing on that we just we need more data to see you know the cadence on how we can we can drive that growth accelerating you know building on this this strong user base that that we have in place as of today.
Okay, great. Thank you very much.
Thank you. Our next question comes from Matt Catherine from Wittenberg Stallman. Your line is now often.
Good afternoon.
Hi may I have a little bit.
Hey, Justin.
Focus on Israel of launching a congrats on the initial progress Sir.
What are you seeing in terms of how it was rella is being used in the real world can you talk a little about the duration of therapy, and how they're incorporating it into their treatment regimen.
Thanks for your question that yes, I think.
What we're seeing is exactly what we're seeing in the real world is exactly what we had gleaned from all of our comprehensive market work done prior to launch and that is that they are currently treated patients that they see on a regular basis. Many of them have had persistent symptoms, but prior to the law.
<unk> there were no additional alternatives. So what we're finding is when we present the profile of its <unk>.
Physicians immediately have many patients in mind and and really it's the process of activating the interest into behavior is around integrating it into their daily practice once they see that the path to access is clear the understand the administrative process. They have to go through to for the patient to access it.
Thriller. So so that's what we're seeing out in the marketplace. It's it's really the patients that they see on a regular basis.
Or to the launch there were no other alternative for them.
Okay, and then you mentioned that you expect continued growth.
<unk> and you're expected to accelerate potentially.
What do you are there certain things you need to accomplish with respect to access in pairs to see that acceleration and and growth momentum to continue.
From a pair standpoint, as we stand here six months into the lunch. The majority of major payers have evaluated thriller and have put forth policies to access a thriller and we're seeing that you know very favorable prior off right as.
A resolved so so our access task as of today is really.
Really one more positive growth driver for the product and what we're seeing in the marketplace is that increasingly offices are seeing as they gain experience with Israel out that patients. In fact do you have access to a thriller as long as the office you know submit the prior authorization with the proper information included cause there.
Finding that the patients they see everyday already meet the pay or criteria because this there's limited options and they had been managing these patients with those options. These patients meet the criteria. So uhm. So so the access profile uhm is becoming quite clear moving forward, where are we will drive growth.
Continuing to expand to use the cross our users and continuing to build a new user base and <unk> continuing to reach all of these high writing a C P who have the potential to use a thriller.
Okay. That's that's helpful. Thank you.
Unexposed upcoming panel add com.
Assuming a positive outcome, okay I come what are the next steps towards re submission of India.
Yep, Thanks, Matt so.
Sure. It it depends on what comes out of the advisory. So we are under the formal dispute resolution process under the off some new drug led by Dr. Peter sign in so.
We will have to see.
What comes of the vote and doctors.
Office's decision, yes ideal has.
Is a 30 day period to respond.
Post Advisory committee to give us an update on our P. O N. We will take that information and then react you know we will do our best Uhm should it be favorable to resubmit as soon as possible, we do need to resubmit. It N D. I as we are not on file, but we don't know until this all happened to one of the next step Sir So I assure you we.
Keep everyone is formed as soon as we possibly can on our password and timing.
Okay, great. Thanks, Justin and good luck on the 16th.
Thank you.
Thank you as a reminder, if you'd like to ask a question you could do so by pressing zero one on your Touchtone phone. Our next question comes from Chris Howerton from Jefferies. You're mine is now open.
Hey, everybody. Thanks, so much for taking my question I had a couple on the Israeli <unk> launch excuse me one part of that was if you could just help us understand how we should be modeling and understanding the impact of stocking inventory.
And then the second part of the Thrill of lunch to ask was on next year for plan research do you expect that to be material in terms of impact to the first quarter sales.
And then the third question I had just as a very minor clarification with respect to the Advisory Committee.
Do you could you give us your latest understanding with respect to the timelines of when the roster will be made publicly available.
Well as when the documents will be made available. Thank you.
Sure.
We'll do our best we might going backwards order Chris.
So there is a standing.
Cardiovascular Arena drug Advisory Committee roster that is posted on your website. So there is a group of individuals who are seated if you will.
Doctor sign may or may not augment that we believe you will.
But and that will be made known two days before the typical cadence is for the post documents two days before so we don't know.
Any more than that right now.
And so we're we'll see okay, yeah sure.
Next I'm going to a thriller so so far we you know we have been selling through the wholesalers and then onto special confirmed especially pharmaceutical companies and so there has not been a lot of stock into there is not a lot of the drug and the channel I don't know, we can't give specifics that it.
But we're we're not seeing uhm excessive stocking and the channel at all which is helpful. We're seeing a real nice 12th of inventory moving out of our if you will.
Supply of inventory and then through the channels and occupation. So we're encouraged by that we don't have specifics yet and hopefully we'll be in a position to give them more.
Netflix if you will with Q1 of next year or something like that where it's just too early to tell.
Excuse me do you Wanna come in any more on that.
No just that I was excellent I mean day and age the capabilities to be able to get product two locations to be able to dispense product. It's extremely fast process. So our entire.
You know supply process is really quite harmonious in terms of what we what we sell in it is really based on what they are selling out is Justin mentioned.
And Chris do we not answer your first choice.
[noise] no no I think I was the only other question was on kind of the potential impact of plan research in the first quarter of next year.
Go ahead and reset so Susan that's a question on our customer base and you know obviously there coverage gaps.
Gaps they may or may not have in their coverage of insurance.
Yeah. Thank you for the question credit. Thank you Justin Yes. So we're really again, if you look at the whole go to market approach and <unk>.
In the treatment paradigm the patients that are candidates for gellar patients that have persistent symptoms despite used with existing treatments and the pay your policies are in place that's.
That state that the drug is accessible if a prior office submitted and its documentation.
The patient so that we see that as a relatively stable what's important around that is that the offices increasingly get comfortable with that process from an affordability standpoint for the commercials segment of our business. We have our commercial copay program. That's been very effectively at nighttime redemption, right, then and as a result of nine.
Profile Uhm, a commercial patients as part of Arabs Rella patient base, but we're also finding Chris that the government entire segments Medicare Medicaid we are drawing patients windows segments, as well that patients who have pretty low copay requirements, largely because they're either medicaid patients or dual eligible Medicare patients.
So we're really not dependent at this point, our basic business I'm on the standard the patient, which is which is the group that may fluctuate to some extent based on plan reset yeah.
Sure, Okay, well I appreciate it.
Offer my best of luck to the panel coming up soon.
Yeah, Thanks, Chris and I, just I just want to make sure I clarify for you and your <unk> your call from city editor earlier similar question. So after the.
The process and Doctor Stein should he render a favorable appeal, which again you said he would render within 30 calendar days of the five to three meetings, we would seek to resubmit the N D. A.
Soon as we possibly can in all depends on what comes out of Doctor size response to us, but I wouldn't want want everyone to know that should we reached with the N D. A and is.
Going to be either a two or a six month review it would not be a 12 month typical M b a cycle.
Rob Blanks can you clarify that or perhaps augment the.
Thanks, Justin Yeah, I mean, I think you you spoke to that perfectly obviously, they once you submit they determine whether it's a two month review or a six month review and obviously it'd be depended on.
What we hear from Doctor Stein 30 days after the.
Advisory Committee meeting.
Thank you Rob.
And we have no further questions in queue at this time I would like to turn the call back to Justin for closing comments.
Thank you all for joining our call. We look forward to keeping your prize of our progress, which you can tell we're really excited about the commercial advanced <unk> Netflix for clothes, we have a lot going on in the next few months and we look forward to keep you apprised of our progress.
You all for joining us today operate evening out and Nicole.
Thank you ladies and gentlemen. This concludes today's conference. Thank you for your participation you may now disconnect.
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