Ardelyx - Earnings Call - Q3 2022

Transcript

Speaker 0

Welcome to the Ardellic twenty third quarter twenty twenty two earnings conference call. My name is Sean, and I 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. As a reminder, this conference call is being recorded.

I will now turn the call over to Kamiya Keshpod of Ardellic. You may begin.

Speaker 1

Thank you, and good afternoon, everyone, and welcome to our third quarter financial results call. During 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 ardellix.com. On the call with me today are Justin Renz, Chief Financial Officer and Susan Rodriguez, Chief Commercial Officer, with prepared remarks. Doctor. Laura Williams, Chief Medical Officer Doctor.

David Rosenbaum, Chief Development Officer and Rob Goynx, Chief Regulatory Affairs and Quality Assurance Officer, will join us for the question and answer period. Our CEO, Mike Robb, won't be on this call as he is doing well 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 ardalix.com.

While we may elect to update these forward looking statements in the future, we specifically disclaim any obligation to do so even if our views change. With that, let me pass the call over to Justin for opening remarks.

Speaker 2

Thank you, Kimiya, 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 position to be a stand alone drug innovator in the midst of commercializing a first in class drug discovered and developed by Ardellix and generating revenue while advancing our pipeline. We are now six months into launch, and we're pleased to report that IZERRALA is resonating with prescribers and patients as an important new treatment option for IBS C. We are clearly gaining traction and building momentum in this marketplace.

These early days have given us confidence that both patients and prescribers are embracing ADRELA and are 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 indicates significant and growing enthusiasm for Azrella. We have an important upcoming regulatory milestone in two weeks, when on November 16, the Cardiovascular and Renal Advisory Committee will review and discuss EXFOSA, our novel treatment for controlling serum phosphorus in adult patients with CKD on dialysis. We look forward to presenting our data and rationale to the committee and updating you afterwards. Now turning to our Japanese partner, Kaiwa Curen Corporation or KKC and their progress with hyperphosphatemia in Japan.

On Monday, we announced that KKC had submitted a New Drug Application or NDA for tinapronort to the Japanese Ministry of Health and Welfare. Importantly, we strengthened our balance sheet with $35,000,000 expected this quarter based upon this recent submission. This is an exciting collaborative milestone achievement that demonstrates the commitment to the program and further reinforces the drug's promise to address the needs of patients with hyperphosphatemia. As Mike often comments, Ardellix is uniquely positioned in the biopharmaceutical industry as a company with a proven track record from an internally discovered therapeutic pipeline. We created tinapadol in our research laboratories and successfully advanced IBRA to all aspects of development, culminating in building a commercial organization to establish this medicine in a market with a high unmet need in IBS C.

Further, we are privileged to have our Japanese partners pursue approval in their territory for tenapanor for hyperphosphatemia, while we continue to pursue approval in this indication in The United States under the brand name Exposa. We take great pride in our accomplishments across our programs, which we attribute to our dedicated, tenacious and talented teams across the company. Now I'd like to pass the call to Susan to provide more details on the building momentum for ADRELA and the important role it will play in the treatment of IBS C. Susan?

Speaker 1

Thanks, Justin. I'll touch on several topics today. First, that our Xbrella launch strategy is working. We are gaining traction and are well positioned to continue to build market share. Next, I will review market response 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. As Justin mentioned, we are six months into our launch, and I'm pleased to report that is rapidly becoming established as an important new treatment for IBS C. Net product sales of IZRELA were approximately $4,900,000 for the second quarter of our launch and nearly $7,000,000 from launch to the end of the third quarter of this year. HCPs are enthusiastically adopting ADRELA because of its novel mechanism of action and robust clinical data. They are viewing IZRELA as an accessible new therapy and are integrating IZRELA into the office practices they have in place to manage specialty drugs.

Offices are submitting prior authorizations and experiencing favorable approval rates since most of their patients have been treated with the limited option, which is the criteria in place across most payers. Early reports of patient treatment experience have been positive, driving interest and expanded use to the sizable pool of patients under their care who continue to suffer with persistent symptoms despite treatment with a GCC agonist. Our strategy is working. When we announced the launch of Ibsrela earlier this year, we emphasized four core elements of our strategy that were innovative and not seen before across the IBS C therapeutic space. These strategies were designed 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 IBS C Rx market with limited treatment options and a recognized unmet patient need.

I will briefly review these core disruptive elements today and the results we are seeing during the first six months of launch that reflect growing market traction and are predictive of continued success.

Speaker 3

The first core 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 IBS C. This is

Speaker 1

a critical market dynamic for it indicates the potential to address an existing clinical need with a novel product offering with a promotional focus centered predominantly on treating HCP. This targeted focus enables the ability to access value from the existing IBS C Rx market in contrast to the products we've launched over the last decade and needed to build the market through heavy direct to consumer spend. Additionally, our market assessment informed us that HCPs considered IBS C to be a condition with a multifactorial pathophysiology and in this context view the therapeutic of IBS C to be characterized by limited single mechanism treatment options. They reported that due to the limited options, many patients under their care continued to suffer with symptoms and were in need of a different treatment approach. All of these market insights are central to the potential for a novel mechanism agent like Ibsrela.

And I am pleased to report that our on market experience has confirmed these dynamics. With our sales force now deployed for six months, the SPHERIX tracking results report that sixty percent of HCPs have seen an Idrella rep with a sixty four percent overall awareness level. Ninety percent of the HCPs who are aware of Idrella rated it as an advanced versus existing therapies. Forty four percent of HCPs 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 focused on the clinical need amongst patients who've been treated with an existing therapy and need a different approach.

Success

Speaker 3

of

Speaker 1

our access strategy centers on two critical factors. One, recognition by HCPs and payers that Idrella addresses an important clinical need as it works in a manner that is novel versus available branded options. And two, establishing Azrela as a specialty drug that could easily be integrated into currently existing office procedures to secure prior authorizations needed for patients to access therapy. Six months into our launch, payers have evaluated Idrella and the policies they have established enable a path to access for Idrella on the basis that the patient has been treated with a limited treatment option and is in need of a different approach. The PA approval rates we see reflect the size of a subset of the treated population who meet these criteria and the office willingness to submit the prior authorization required to access Idrela.

The fact that the pool of IBS C patients currently under the care of high treating HCPs have typically been treated with an existing therapy, combined with the HCP willingness to submit the prior authorization request, will continue to support a favorable patient access environment for Ibsrela going forward. Third, our launch is centered on driving early experience with Ibsrela to establish it as a critical part of what is now an expanded IBS C treatment armamentarium. HCP experience with the early patients they have treated with Ibsrela has been favorable, reflected by positive refill rates, as well as the launch tracking report issued by Spirix, where forty two percent of Ibsrela users reported moderate satisfaction, which is a rating of four to seven on a scale of 58% reporting high satisfaction, which is a rating of eight to 10 on a scale of 10. Additionally, current users projected that their use would increase significantly over the next six months. And fourth, and quite notably, we have achieved this strong start with a targeted promotional approach not seen before in the IBS C space, 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 HCPs managing a high volume of IBS C patients with demand not dependent on DTC spend and access not dependent on heavy payor rebating. Additionally, we are achieving early uptake at a price aligned to the clinical value proposition of Ibsrela as those patients in need of a different approach have had no other options prior to the launch of Ibsrela. In this regard, Ibsrela's position in the market is unopposed. Demand for Ibsrela will be driven by HCP adoption for those patients in clinical need of this first in class novel mechanism drug 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 ISRELLA, access we are experiencing for in person rep engagement with offices, the favorable patient access environment, and strong market momentum.

Our sales force will leverage this early user base to expand use to the sizable number of HCPs considered to be candidates for IBSRELA 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 platforms, social platforms, electronic health record platforms, and rep driven communications will be further targeted and personalized as we leverage the increasingly informative HCP engagement data we have collected since launch. Content will continuously be refreshed, including comprehensive opinion leader video vignettes that reflect the important role Azrela has in the now expanded IBS C treatment armamentarium based on their own clinical experience. We will leverage digital formats to deliver in person speaking events across multiple locations concurrently.

In person rep follow-up will be further amplified by targeted emails with continuously refreshed content capitalizing on the high open and engagement rates we are seeing across our highly digitally engaged targeted HCPs. Our launch of Ibsrela embodies all that is possible in this post COVID environment, leveraging the power of focused 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 launch demonstrates strong market performance indicators of interest, adoption, access, and favorable treatment experience. Our strategy is working. Ibsrela is gaining traction with a strong foundational market presence in place that is predictive of future market penetration, revenue growth, and company profitability.

We expect to further bolster this growth through our prudent investments aimed to accelerate our future success. I will now turn the call back to Justin to review our Q3 twenty twenty two financials and to provide some closing remarks. Justin?

Speaker 2

Thank you, Susan. As of 09/30/2022, we had total cash, cash equivalents and short term investments of $90,600,000 As Susan mentioned, our third quarter net product sales of ADRELA were approximately $4,900,000 and we had total revenue of approximately $5,000,000 R and D expenses were $7,500,000 for the third quarter of twenty twenty two, a decrease of $16,200,000 or 68.5% compared to $23,700,000 for the same quarter in 2021. R and D expenses included noncash stock compensation expense of approximately 500,000.0 and $700,000 in the quarters ended September thirty of twenty twenty two and 2021, respectively. The decrease in R and D expenses is primarily the result of lower clinical study costs as a result of the completion of the OPTIMIZE study, lower tinapador manufacturing expenses due to the capitalization of costs associated with production of IBSRELA into inventory and lower expenses from research in general following the significant reduction of our research function in the fourth quarter of twenty twenty one. SG and A expenses were approximately $18,700,000 for the third quarter of twenty twenty two, a decrease of $1,000,000 or 5.3% compared to $19,700,000 for the same quarter in 2021.

SG and A included noncash stock compensation expense of approximately $1,400,000 and $1,500,000 in the quarters ended 09/30/2022 and 2021, respectively. The decrease in SG and A was primarily due to a reduction in both our ongoing expenditures as well as onetime costs as a result of restructuring action we carried out during the third quarter of twenty twenty one, offset by increased costs associated with the continuing commercial launch of Ipsrela during the third quarter of twenty twenty two. Our net loss for the quarter was $22,900,000 or $0.14 per share compared to $43,600,000 or $0.42 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 transactions this year that help us achieve this goal.

First, we refinanced our term loan debt with Solar Capital, and we are in interest only payment mode until April of twenty twenty four. As previously mentioned, we also amended our KKC license agreement in April, which we followed up with a royalty tail financing agreement with Healthcare Royalty Partners or HCR in June. Notably, these combined transactions have provided us with significant non dilutive capital. As I mentioned earlier, as a result of KKC's recent NDA submission, in the fourth quarter, we will receive an aggregate of 35,000,000 in milestone payments and payments associated with the April 2022 amendment of the license agreement. Moreover, we are eligible to receive additional payments from KKC following the potential approval of their NDA for tenapanor for the improvement of hyperphosphatemia in Japan, which we expect to occur in the second half of twenty twenty three.

Under our agreement with HCR, we received a $10,000,000 upfront payment in June of this year, and we expect to receive an additional $5,000,000 next year following KKC's potential receipt of regulatory approval. We also have an opportunity to receive additional $5,000,000 in the event that net sales in Japan exceed a certain annual target level in 2025. In return, HCR will receive the royalty payments and commercial sales milestones that may become due to us under our revised agreement with KKC. We will continue to pursue all efforts to strengthen our balance sheet and exercise judicious cash management. Balance We remain confident in our ability to continue to fund our operations.

Before opening the call for questions, I'd like to again emphasize our progress. This is an exciting and transformational time for Ardellix. Few companies compare to our potential as an evolving commercial growth story with many opportunities ahead. Again, our IBSRELA strategy is working. The opportunity is significant.

We're gaining meaningful traction. We have a clear line of sight to financial breakeven. Beyond Ibsrela, we look forward to making the case for EXFOSA to the FDA's Advisory Committee on November 16 as we believe it is important to provide additional treatment options for patients with CKD on dialysis with hyperphosphatemia. And finally, I want to emphasize we remain committed to being good stewards of capital. We look forward to keeping you apprised of our progress.

Before we open the call to questions, we understand and 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. We look forward to presenting our data and rationale to the committee in two weeks and updating you afterwards. With that, I will now turn the call to the operator. Operator?

Speaker 0

Thank you. We will now begin the question and answer Our first question comes from Yigal Nakhlavovich from Citigroup. Obviously,

Speaker 4

I'm getting a lot of questions about the upcoming adcom, and I know you probably can't say very much. But are you able to just factually say whether this will be an AdCom where there'll be a yesno vote at the end of the day? Or is it just going to be more qualitative commentary?

Speaker 2

Thank you, Yigal, for asking that question. I'm going to turn that to our Head of Quality and Regulatory, Rob Waterson.

Speaker 4

Yes. Yigal,

Speaker 5

obviously, we're not going to speak to details about that. The questions and discussion areas and the voting questions will, if they come, will come two days before the actual meeting, so two business days. Got it. Okay.

Speaker 2

All right. Well, let's

Speaker 4

turn to IZRELA and the launch. So can you give us some thoughts as far as the how you think the cadence of the launch is going to go in the rest of the year and for 2023? What sort of revenue momentum are you expecting? And what's going to drive that? Thank you.

Speaker 2

Sure. Thank you, Yigal. I'm going to ask Susan, our Chief Commercial Officer, to answer the question.

Speaker 1

Thank you, Yigal, for the question. Yes, so as we mentioned talking about our first six months of experience, we're seeing consistent growth across scripts, a nice growth profile, growth both in new riders it increases amongst existing riders. Looking at the growth 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 progress through the end of the year.

We have a view forward towards giving you some guidance sometime in 2023.

Speaker 4

Got it. Thank you.

Speaker 0

Thank you. Our next question comes from Laura Chico from Wedbush Securities. Your line is now open.

Speaker 6

Hey, thanks very much for taking the question and best wishes to Mike on a healthy recovery. Likewise, getting a lot of questions just with respect to the upcoming advisory committee panel. Maybe I'll ask this a little bit differently. Can you remind us of some examples that have gone through the FER process in which resolution has been identified that did not require additional clinical studies. Is that something that you have any examples that you could point to there?

Speaker 2

Thank you, Laura, for asking. Our situation, as you might imagine, is somewhat unique, and we really look forward to making our case to the AdCom with our treatment data that we have compiled over the years and our, very thorough program that was conducted by David Rosenbaum, Laura Williams, our team. I don't want to comment on and compare ourselves to prior because each situation is different. And so I don't think that would be fair to do. So again, we prefer to not comment on other situations because we believe we're in a unique situation.

Speaker 6

Okay, understood. I might ask one follow-up. So we're at the ASN meeting and saw some of the poster presentations you have for Tenapanor or Kyowa Kirin has. Any commentary just with respect to, I guess, kind of physician awareness still around Tinapanor and just how has this possibly changed over the past couple of years?

Speaker 2

Yes, thank you for asking Laura. That's an excellent question. I'm going to turn that over to Susan to give an update on her recent experience with this.

Speaker 1

Yes, thanks Laura for the question. Actually, we, with a very comprehensive clinical development program executed to support the NDA for for exposure. As a result, the presence we've had at all of the medical meetings over the last several years, involvement with all of the treating nephrologists involved in our clinical programs, presentation of our data, as well as the launch of a very comprehensive disease awareness campaign throughout 2021. We had a very high level of awareness of exposure across the country across the nephrology treating community. The reports have been tracking the interest in novel mechanism drugs for hyperphosphatemia, the awareness level of exposure persistently over the last several years.

And the very last data point published, I think it was second quarter twenty twenty two, reflects the persistent interest across the nephrology treating community for a novel mechanism drug for new options to address the significant challenges that they put forward in the management of hyperphosphatemia and a high level of awareness and interest in Exposa. We are quite encouraged that the awareness and support across the treating nephrology community is quite high and we will be prepared to be able to mobilize and bring Exposa forward in the event of a positive scenario where we can bring EXFOZA to patients.

Speaker 6

Thanks, guys.

Speaker 0

Thank you. Our next question comes from Joseph Thome from Cowen and Company.

Speaker 7

Maybe right to Ibsrela. In terms of patient numbers, are you going to guide 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 patients on therapy? And do you have a set of patients that are currently have done the referral process and they're just waiting to kind of go through the prior authorization and get therapy? And maybe what's the size of that patient population, if you can provide some information?

Sure.

Speaker 1

Go ahead, Justin.

Speaker 2

No, was just going to say on the first part of your question, Joe, thank you for asking. We're not going to give specific guidance and numbers yet. It's still too early for us to give you specifics and guidance. But we will we are absolutely, as a company, compiling metrics regularly and trying to be in a position as the launch progresses. And again, Susan can give you more examples of the progress we've made in our outreach in general.

But we're woefully to give specifics right now because we're only seven months into our launch, but we are really encouraged by what we see so far. So we're not going to give specifics yet. But I'm going to give Susan the opportunity to expand on that.

Speaker 1

So what I can comment on is information that we have shared publicly as a part of our communication around the launch of the and the opportunity for. Overall the market for IBS C indicated drugs is about 5,000,000 scripts. Based on our assessment of the unmet clinical need across the marketplace based on all of our market research, we see a path forward and believe it's quite achievable to achieve high single digit share position at peak. And everything that we are seeing in the first six months of launch as I reported in my narrative in terms of interest, adoption, intent to expand use, it's all in our path to access of course. Further supports that statement that we made at our launch.

So that's what I wanted to share with you.

Speaker 7

Perfect. And then I know in the prepared remarks you mentioned that there is 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? Is it just the patients coming in? Is it getting, I guess, better reimbursement?

Or, I guess what's stopping them from saying, tomorrow I'm going to write a script versus, you know, kind of over the next several months?

Speaker 1

Yes. What we're seeing in terms of the whole adoption cycle, again, just early, the first six months is our reps getting in it's really just getting the story out. Our message is resonating quite effectively. We get a favorable response and interest to use the Zrella. There is time to work with the office required to make sure that they integrate Zarela as a specialty drug to be able to be prepared to submit the prior auth.

There is the initiation of the early patients they are trying and we are kind of at the state right now where we have a nice user base where we have gone through that process. They've had favorable treatment experience as I reported in the narrative. So now we're embarking on this expanded use phase for the product. Timing on that, we need more data to see the cadence on how we can drive that growth accelerating building on this strong user base that we have in place as of today.

Speaker 7

Okay, great. Thank you very much.

Speaker 0

Thank you. Our next question comes from Matt Kaplan from Ladenburg Thalmann. Your line is now open.

Speaker 8

Hi, good afternoon.

Speaker 2

Hi, Matt.

Speaker 8

A little bit. Hey, Justin. Hey, Susan.

Speaker 6

I wanted

Speaker 8

to just focus on the IZRELA launch, congrats on initial progress there. What are you seeing in terms of how Ibsrela is being used in the real world? Can you talk a little bit about the duration of therapy and how they're incorporating it into their treatment regimen?

Speaker 1

Thanks for your question, Matt. Yes, I think what we're seeing is exact 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 launch of Israel, there were no additional alternatives. So what we're finding is when we present the profile of the physicians immediately have many patients in mind. And really the of integrating the interest into behavior is around integrating it into their daily practice once they see that the path to access is clear, understand the administrative process they have to go through for the patient to access the Zrella.

So that's what we're seeing out in the marketplace. It's really the patients that they see on a regular basis that prior to the launch, there were no other alternatives for them.

Speaker 8

Okay. And then you mentioned that you expect continued growth and momentum and you expect it to accelerate potentially. What do you are there certain things you need to accomplish with respect to access and payers to see that acceleration and growth momentum to continue?

Speaker 1

From a payer standpoint, as we stand here six months into the launch, the majority of major payers have evaluated it and have put forth policies to access it and we are seeing that very favorable prior off rate as a result. So our access path as of today is really one more positive growth driver for the product. And what we are seeing in the marketplace is that increasingly offices are seeing as they gain experience with the drug that patients in fact do have access to the drug as long as the office submits the prior authorization with the proper information included. Because they are finding that the patients they see every day already meet the payer criteria because since there is limited options and they have been managing these patients with those options, these patients meet the criteria. The access profile is becoming quite clear moving forward.

Where we will drive growth is just continuing to expand use across our users and continuing to build a new user base and continuing to reach all of these high riding HCPs who have the potential to use Ipsrela.

Speaker 8

Okay. That's helpful. Thank you. And just on EXFOZA and the upcoming panel, ADCOM, assuming a positive outcome of the ADCOM, what are the next steps towards the resubmission of the NDA?

Speaker 2

Yeah. Thanks, Matt. So in short, it depends on what comes out of the advisory committee meeting. So we are under the formal dispute resolution process under the Office of New Drug led by Doctor. Peter Stein.

And so, you know, we will have to see what comes of the vote in doctor Stein with his office's decision. He has said he will has a thirty day period to respond post the advisory committee to give us an update on our appeal, and we will take that information and then react. You know, we will do our best, should it be favorable to resubmit as soon as possible. We do need to resubmit an NDA as we are not on file, but we don't know until this all happens of what our next steps are. So I assure you we will keep everyone informed as soon as we possibly can on our path forward and timing.

Speaker 8

Okay. Great. Thanks, Justin, and good luck on the sixteenth.

Speaker 2

Thank you.

Speaker 0

Thank you. Our next question comes from Chris Howerton from Jefferies. Your line is now open.

Speaker 3

Hey, everybody. Thanks so much for taking the question. I had a couple on the IBSRELA 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 and inventory? And then the second part of the ABSRELLA launch to ask was on next year for planned resets.

Do you expect that to be on material in terms of impact to the first quarter sales? And then the third question I had just is 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 as well as when the documents will be made available? Thank you.

Speaker 2

Sure. We'll do our best. We might go in backwards order, Chris. So there is a standing cardiovascular and renal drug advisory committee roster that is posted on their website. So there is a group of individuals who are seated, if you will, and Doctor.

Stein may or may not augment that. We believe he will. And that will be made known two days before the typical cadence is for the FDA to post documents two days before. So we don't know any more than that right now, and so we'll see. Okay.

Yeah, sure. Next, going to Ibsrela. So, so far, we have been selling through the wholesalers and then on to especially pharmaceutical companies. And so there has not been a lot of stocking. So there is not a lot of drug in the channel.

We can't give specifics out at all, but we are not seeing excessive stocking in the channel at all, which is helpful. We're seeing a real nice twel of inventory moving out of our, if you will, supply of inventory and then through those channels and out to the patient. So we're encouraged by that. We don't have specifics yet. And hopefully, we'll be in a position to give more metrics, if you will, in Q1 of next year or something like that, where it's just too early to tell.

Susan, do you want to comment any more on that?

Speaker 1

No, Justin. That was excellent. I mean, this day and age, the capabilities to be able to get product to locations to be able to dispense product, it's an extremely fast process. So our entire supply process is really quite harmonious in terms of what we sell in is really based on what they're selling out, as Justin mentioned.

Speaker 2

Chris, did we not answer your first question?

Speaker 3

No, I think I was just the only other question was on kind of the potential impact of plan resets in the first quarter of next year.

Speaker 2

Plan reset. So Susan, that's a question on our customer base and, you know, obviously, their coverage and gaps they may or may not have in their coverage of insurance?

Speaker 1

Yeah. Thank you for the question, Chris. Thank you, Justin. Yes, so we're really again, if you look at the whole go to market approach and where it fits in the treatment paradigm, the patients that are candidates for Abzara are patients that have persistent symptoms despite use of existing treatments. And the payer policies are in place that state that the drug is accessible if a prior auth is submitted and its documentation of the patient.

So we see that as relatively stable. What's important around that is that the offices increasingly get comfortable with that process. From an affordability standpoint, for the commercial segment of our business, we have our commercial co pay program that's been very effective. We have nice high redemption rates and as a result a nice profile of commercial patients as part of our patient base. But we're also finding, Chris, that the government payer segments, Medicare and Medicaid, we are drawing patients from those segments as well, the 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 base of business on the standard D patient, which is the group that may fluctuate to some extent based on plan reset. Yeah.

Speaker 3

Sure. Okay. Well, I appreciate it. And again, I'll offer my best of luck to the panel coming up soon. Thanks, guys.

Speaker 2

Thanks, Chris. And I just want to make sure I clarify for you. And Yigal from Citi had an earlier similar question. So after the process and Doctor. Stein, should he render a favorable appeal, which, again, he has said he would render within thirty calendar days of the advisory committee meeting, we would seek to resubmit the NDA as soon as we possibly can.

It all depends on what comes out of Doctor. Stein's response to us. But I would want everyone to know that should we resubmit the NDA, it is going to be either a two or a six month review. It would not be a twelve month typical NDA cycle. Rob Blank, can you clarify that or perhaps augment that?

Speaker 5

Thanks, Justin. Yeah, I mean, I think 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 would be dependent on what we hear from Doctor. Stein, you know, thirty days after the Advisory Committee meeting.

Speaker 2

Thank you, Rob.

Speaker 0

And we have no further questions in queue at this time. I would like to turn the call back to Justin for closing comments.

Speaker 2

Thank you all for joining our call. We look forward to keeping you apprised of our progress, which you can tell we're really excited about. The commercial advancement of ISRELLA, our NESTEX for Exposa, we have a lot going on in the next few months, and we look forward to keeping you apprised of our progress. Thank you all for joining us today. Operator, you may now end the call.

Speaker 0

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for your participation. You may now disconnect.