Q1 2024 Ardelyx Inc Earnings Call

Participants

Caitlin Lowie; Analyst; Ardelyx Inc

Michael Raab; President, Chief Executive Officer, Director; Ardelyx Inc

Susan Rodriguez; Chief Commercial Officer; Ardelyx Inc

Justin Renz; Chief Financial Officer; Ardelyx Inc

Chris Raymond; Analyst; Piper Sandler Companies

Hugo Ong; Analyst; Citi

Dennis Ding; Analyst; Jefferies

Joseph Thome; Analyst; TD Cowen

Presentation

Operator

Good day and welcome to the Ardelyx First Quarter 2024 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded.
I would now like to turn the conference over to Caitlin Lowie, Vice President of Corporate Communications and Investor Relations at Ardelyx.
Please go ahead.

Caitlin Lowie

Thank you.
Good afternoon, and welcome to our first quarter 2024 financial results.
Call.
During this call, we will refer to the press release issued earlier today, which is available on the Investors section of the company's website at ir dot <unk> dot com. During this call, we'll 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 the risk factors in our most recent quarterly report on Form 10 Q that was filed today and can be found on our website at R-DEL. 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 are President and CEO, Mike Robb will begin today's call with opening remarks and an overview of the Company's progress during the first quarter of 2024. Next in Riga, Chief Commercial Officer, will provide an update on the performance of its rollout and exposure. Justin Renz Chief Financial and Operations Officer will conclude today's prepared remarks with a review of the Company's financial performance during the first quarter ended March 31st, 2024. Before we open the call to questions. And with that, let me pass the call over to Mike.

Michael Raab

Good afternoon, everyone, and thank you for joining us on this call. Q1 earnings always seemed to come quickly after we report our Q4 results. And yet as usual, a lot has happened since we last provided you an update first exposes performance out of the gate following the launch. November continues at a remarkable pace. This is the first in class product in a therapeutic area that has seen no innovation in decades. The response from the person prescribing community clearly demonstrates the significant unmet need. Among this patient population exposure is an important new option for physicians to help patients whose serum phosphorus remains elevated. Despite best efforts. All demand indicators are favorable. Prescribers are eager to learn more about exposed blocking mechanism and are working to identify potential candidates for therapy like it's relevant for Ardelyx assistance, supporting prior authorizations and helping patients take advantage of our affordability programs. Patients are accessing the drug and the feedback is that patients are seeing sustained reductions in their serum phosphorus. We are focused on ensuring prescribers are aware and educated on exposing and ensuring patients have access to treatments. As you can see by our performance, it's going very well because really continues to perform strongly, providing an important option to again address a large unmet need among IBS-C patients. We believe that this can be a $1 billion product. And on the path to achieving that peak, we expect full year net sales revenue for 2024 to be between 140 and 150 million. As I consider the first quarter performance, the underlying demand metrics and fundamentals of the business are robust and continue to demonstrate growth in new and repeat writers and new and refill prescriptions. Our reported revenue reflects demand growth, offset by the impact of seasonality, which standard across the industry that we experienced during this first quarter. Importantly, our cash position remains strong, resulting from our revenue. The third traunch of debt from our partnership with SLR and thoughtful management of our expenses. We are in an exciting time in our evolution as a company, and our top priority is to build upon the growth momentum of its rollout and exposure.
Now I'll turn the call over to Susan to discuss first quarter performance for both of our products.

Susan Rodriguez

Susan, you, Mike. It is great to be here today to discuss the commercial performance Barbara and exposed. Our performance reflects strong execution of our disruptive commercial approach for both first-in-class products, which centers on targeting the high-volume writers in our disease areas, driving identification of patients in need of a novel treatment option is their response to existing treatment options is deemed to be inadequate and enabling patient access and affordability with favorable coverage policies that define the path to act prior authorization support and patient support program.
Let me begin with Enbrel. Our confidence in this product is driven by the strength of the fundamentals driving its earnings performance. Hcps are evolving their treatment practice now that they have expanded treatment options for their IBS-C patients following the launch of the drug based on the favorable clinical response they are seeing and confidence in the path to access HCPs are increasingly identifying patients in need of a novel treatment option.
During the first quarter, we saw increases across all key demand parameters for the products, including growth in new writers and repeat writers as well as growth in new prescriptions and retail prescriptions. Very encouraged by the continued growth of these key demand metrics, despite Israel being impacted by first quarter seasonality that is commonly seen across the industry linked to insurance plan resets and prior authorization renewal processes during the first quarter, we began the process to expand the Abdullah dedicated sales force footprint from 64 territories to 124 territories. We experienced a strong response to the job posting attracting sales talent with extensive JNI experience. We are motivated and enthusiastic to join the internal sales team and be part of disrupting the IBS-C market with an innovative therapy training and full deployment of this team is on track to be completed by the end of the second quarter. Net sales force footprint puts us in a strong position to capitalize on the promotion sensitivity we have seen across our high writing HCP. target to further, it drives increases in new writers as well as drive expanded use across our growing writer base who are continuously broadening their view of patients who are candidates for Xyrem. The fundamental drivers behind Israel are strong, and we anticipate continued quarter-over-quarter growth with our expectations for the 2024 performance. Consistent with our stated guidance, you can expose that we are extremely pleased with the nephrology community's response to this first-in-class phosphate absorption inhibitor. It is clear that patients have been in need of a new option to manage their phosphorus when binders are insufficient or not well tolerated. Our dedicated nephrology sales team, comprehensive blocking messaging campaign SPEAKER promotional programs and omnichannel initiatives are driving high interest and early uptake of Victoza. Nephrologists are responding favorably to the novel blocking mechanism and clinical data profile and are pleased with their early clinical experience, encouraged by the defined coverage policies and increasingly integrating this novel blocking mechanism product into the therapeutic regimen for their patients. The feedback we regularly receive from the field is that physicians are seeing that they're exposed to treated patients, many of whom have been continuously outside of target ranges are reflecting consistent improvement in serum phosphorus levels. And that these levels are being maintained. We are also hearing that patients are responding favorably to the dosing profile and that HCPs are pleased with the flexibility they have in adapting the patient's treatment regimen where they can add exposure to the patient's existing binder regimen for they can annex those and reduce the patient's binder regimen or they can annex those and fully discontinued a patient's binder regimen. Hcps are adopting exposed and are adapting regimens based on the needs of the patients. We are very pleased with the $15.2 million in sales we reported for Exa during the first quarter. This performance is consistent with the uptake indicators we are seeing in the field. Our sales force is experiencing highly engaged, meaningful discussions with our target HCPs who are eager to learn about exposure. Nephrology HCPs are rapidly identifying patients who they believe can benefit from therapy reporting to us that they may have many patients outside of target ranges despite treatment with binders or are intolerant of binder therapy. Hcps are pleased with the clinical response they are seeing and patients are responding favorably to the treatment experience coverage policies are being defined that outline a path to access via prior authorization, attesting to the fact that the patient has been treated with binders and inadequately responding or unable to tolerate the therapy. Hcps are seeing that one prior authorizations are submitted for patients meeting the criteria. Patients are gaining access to exposure, nephrology, HCPs and their office staff are responding favorably to our specialty pharmacy distribution network as well as through our comprehensive patient services offering. Ardelyx assist that further enable patient access through prior authorization support and patient engagement with the affordability programs available to them. Our metrics are supported by external research conducted by Spirox, who's tracking the launch of expos. According to the April 2024 launch dynamics report nearly all of the 77 surveyed nephrologists, 98% rate exposure as an advance over currently available hyperphosphatemia therapies. In addition, 56% of the surveyed nephrologists reported using exposure and of those, again, 98% report satisfaction with treatment. The research demonstrates that awareness is high among the nephrology community interest and intend to adopt is high and satisfaction with the treatment is high among users. We will continue to build upon our launch momentum, capitalizing on the high nephrology awareness of the number of patients that are in need of a new treatment option despite treatment with binders and their intent to adopt expose for these patients.
Our go-to-market strategy is working. We have established a strong presence in nephrology offices across the country and HCPs are responding favorably to the novel blocking mechanism and clinical data profile. We are identifying patients that could benefit from expose the therapy and with coverage policies in place patients are gaining access and responding favorably to treatments. We are pleased with the performance thus far and our focus on continuing this growth momentum. We have several exciting months ahead as we will have strong commercial and clinical presence across key annual medical conferences for both Estrella and exposure, where we will have the opportunity to present more clinical trial data on our products, connect connected the prescribing community and deepen our relationship with patients. I look forward to continuing to share updates with you in the future with I will hand it to Justin Thank you, Susan.

Justin Renz

I'm very pleased to be with you today to discuss the first quarter performance we reported, which included meaningful progress towards our IFS relevant net sales revenue guidance, a strong launch of exposure, careful management of our finances and a strong cash position.
Let's start with revenue. As you saw in this afternoon's release, we reported significant year-over-year growth, bringing our total first quarter product related revenue to 45.6 million compared to $11.4 million in the first quarter of 2023. Net product sales revenue firms roll-off was 28.4 million during the first quarter of 2024, more than doubling the 11.4 million in revenue we reported during the same period in 2023 and a 1% quarter over quarter growth compared to the fourth quarter of last year. Volume demand grew for Reliq during the first quarter, which was offset by deductions associated with the reset of annual prescription drug plans. Most notably, this was related to our commercial co-pay program. The impact of the commercial co-pay program is most significant in the first quarter when most commercial healthcare plans reset and patients have higher out-of-pocket requirements as patients fill prescriptions throughout the year and begin meeting their deductible requirements.
Our expenses related to the commercial co-pay program declined. Our gross-to-net deduction firms rollout during the first quarter was in line with our expectations at 33.5% and comparable to the 33.7% we saw in the first quarter of 2023. We expect this percentage to improve as the year progresses as it did last year. In addition, we saw the anticipated impact of the prior authorization renewal process that occurs at the start of the calendar year for many health care plans, strong demand and expected improvement in gross to net deductions reinforce our confidence in the ongoing performance of a drop. As such, we continue to expect that full year U.S. trailer net product sales revenue will be between 140 and 150 million exposure had an exceptional first full quarter performance as we are reporting 15.2 million in net sales revenue, driven by the meaningful demand for this product, our gross-to-net deduction caving favorably for exposure at 23.8% as we progress into the launch of exposure and more and more about the patient mix that drives the associated gross to net deduction, we will share more. In addition, we had 2.5 million in combined licensing and product supply revenue. We are very pleased with our top line results during the quarter, which demonstrated the growth momentum. Mike and Susan both spoke to at the same time, we continue to be thoughtful in how we manage our expense research and development expenses were 10.6 million compared to $9.1 million during the first quarter of 2023. Selling, general and administrative expenses were $53 million for the first quarter compared to $26.8 million for the same period of 2023. The increase was related to launch activities for frozen as well as continued investments to grow its relevance, which we made throughout last year. Importantly, our costs were comparable to our spending in the fourth quarter of 2023. We expect to complete the current expansion of the Trellis sales force that Susan previously mentioned by the end of the second quarter, substantial top-line growth combined with thoughtful cost management, resulted in a net loss of approximately $26.5 million or $0.11 per share in the first quarter of 2024 compared to a net loss of $26.8 million or $0.13 per share in the same period of 2023. Net loss for the first quarter of 2024 included 9.3 million in combined non-cash expenses from share-based compensation and non-cash interest expense related to the sale of future royalties.
As of March 31st, 2024, we had total cash, cash equivalents and short-term investments of 202.6 million as compared to $184.3 million at the end of 2023. This includes $49.8 million in net proceeds that we drew in March from our term loan agreement with SLR capital, we are very pleased with our performance during the first quarter driving top line growth across all reported revenue lines, planning for success, investing in our supply chain, managing our operating expenses and strengthening our cash position. We will continue to be thoughtful with how we deploy capital while focusing on maximizing shareholder value.
With that, we'll turn it back to Mike.

Michael Raab

Thanks. Just and I hope that what you took away from our performance during the first quarter is that one, we continue to have high expectations for its rollout, including 141 hundred and $50 million in net sales revenue. This year and on the path to at least 10% market share and $1 billion in annual revenue to expose the launch. Progress is exceptional and it is already beginning to disrupt the hyperphosphatemia market where there remains significant unmet needs among patients.
And finally, we are in a strong cash position to invest in growth. We have a lot of important work ahead of us, and we have a team in place who is able to deliver. I look forward to sharing our progress with you over the coming quarters. And I will now open the call to questions. Operator?

Question and Answer Session

Operator

(Operator Instructions) Chris Raymond, Piper Sandler.

Chris Raymond

Hey, thanks and congrats on the great success here with Victoza. Just Tom, maybe one question on that and a follow-up as well. I know you guys are early in the launch and you've already established sort of a cadence here for guidance after having a number of quarters that you've set with AdRelevance, but the magnitude of this speed is obviously more than anybody expected. Can you provide maybe any sort of color here. And I think everybody sees the scrip data. And if folks were following that, they're even surprised. Those who have been following the script data closely are surprised by the number and any sort of color in terms of the uptake and what we should be thinking in terms of the implications for the for the next several quarters?
Couple of quarters anyway, and then maybe the follow-up is, I know, Mike, you're not in the business of predicting legislation, but in the absence of sort of any any progress in terms of volume pushing the from the phosphate binders into the bundle from pushing that off. At what point do you start maybe planning for that as a real?

Michael Raab

Thanks, Chris, and thank you for the questions. I guess first of all, I hope by now you can tell that we're not quitters and that we see what we're doing for patients and the uptick that we see with exposure is it has been absolutely worth the fight that we're fighting. I think, as you see with what we've done with the trial us in IBS-C patients as well deserve the attention that we're giving them what you saw with its relative as we need, and we expect to have roughly four quarters under our belt before we give guidance, we don't want to get over our skis. We are excited and thrilled by this performance and the anticipation for the drug out there. The enthusiasm our ABDs are seeing in the field is remarkable and the ability that we have in helping people through the prior authorization process process through our Delta system is working extraordinarily well based on some of the learnings that we got through with its role. So although I would like to give you a clear answer on both of those, I'm sorry, I'm sure you understand and I can't Got it.
Thanks.
For trying.

Yes.

Operator

Hugo Ong, Citi.

Hugo Ong

Hi, Mike and Susan, and just some team. Thank you so much and congrats as well on a very strong launch.
And I just had a few questions on the commercial franchise regarding Israel. And can you comment on the percent that were new writers versus repeat writers in the quarter and then with almost doubling in the territories, how do you expect that to scale in terms of the size of that, the base of the prescribing physician community and then with expose you nicely articulated three buckets, the ones where you add expose and get them to goal and ones where you can add and then reduce the buy-in and then even it expose and potentially remove the binder altogether, do you have any anecdotal or early evidence or data to discuss sort of roughly what percent fall into each of those three scenarios thinking?

Susan Rodriguez

Yes. Thanks for the question. In terms of the new and repeat writing, we had we have not disclosed the specifics in terms of those percentages. So what I can tell you that's a really important metric to track is just the persistent of new riders being generated weekly, monthly quarterly. And what we're seeing since launch is that this has been persistent with new riders being generated constantly on a weekly, monthly and quarterly basis. So seeing that persist really gives us great confidence in the momentum and our guidance for this year in terms of repeat writing. But what was important to note there is that now that we're several quarters into launch, we have the data to show that new riders right again. So we're seeing that repeat writing is also persistent where the growth opportunity is is in continuing to drive that new rider growth. But then also amongst that growing writer base really growing depth of writing. So these repeat writers could write more often and for more patients. And what our sales force is executing on is really driving that broader view based on the foundation of positive experience they've had to date of patients that now really need to be considered as candidates for Zejula because they do have persistent symptoms have been tried on other things. And now physicians have seen that there is a path to access and that patients are responding well. So they're broadening their view on potential candidates. And that's really an important growth opportunity for us as well.
In terms of the sales force impact, that's exactly why we believed it was critical to continue to invest in our salesforce footprint because our experience to date shows that the spaces quite promotion-sensitive. So the more we call on doctors, the more they write is rollout. We see that relationship, the more they engage in all of our omnichannel initiatives and in our program, the more it's relative, right? So still expanding our footprint from 64 to 124 really gives us an opportunity to get those and get into the HCP offices more frequently to continue to drive that expanded writing and really capitalizing on the fact that they are broadening their view on patients who are candidates for exposure and at the same time can also continue to penetrate our target space and generate new writers. So really being able to execute and we've been able to achieve both.

Hugo Ong

Okay, great. And then if you could if you could comment on the exposure question. Do you have any data there regarding the way it's bucketing the reducing the by nurses?

Susan Rodriguez

Yes, not specifically from a percentage standpoint, your goal, but what we're hearing persistently is that all nephrology, you know, in general nephrologists are just commenting on the flexibility and that's what's really exciting because that means that that patient group that they identify that they believe is inadequately managed on binders or don't tolerate binders. They see exposure because of its complementary MOA blocking mechanism of action as a drug that that patient could benefit from and there and they don't have a going concern around how it gets integrated because they can be flexible on initiating therapy and then perhaps some of them are initiating tracking and then taking them up some of the binders, some of them just cut the binders right away some of the time they just eliminated entirely, as I mentioned in my narrative. So what we hear more is that what each doctor is actually using the drug with this level of flexibility and that they see that as a way to really be able to realize the benefits of novel mechanism across the across their patients that they see are inadequately managed and you guys might just one additional comment with that is, I think as we spoke of earlier in other calls, is you've never had multiple mechanisms like you do with so many other diseases to manage what the drugs are trying to address.

Michael Raab

So it's not going to be a static ratio in any given patient. There's going to be an inter and intra-patient variability depending upon their serum phosphorus. There's now flexibility and tools for these physicians to finally get fosters in the target range that they're looking for. So I think that's going to evolve. And as we understand that better in the coming quarters, we'll certainly share it.

Susan Rodriguez

Great.

Hugo Ong

Thank you very much.

Operator

Next question comes from Louise Chan with Cantor.

Please go ahead.

Susan Rodriguez

Hi. Congratulations on all the progress this quarter.

Caitlin Lowie

And thank you for taking my questions here.

Susan Rodriguez

So first question, I wanted to ask you about was ex those items 15.2 million is all demand sales or is there any stocking in there?

Caitlin Lowie

And secondly, just back on the body color, Bill, if it doesn't move through that, is that 1 billion of peak sales you have for Iberdrola at risk or that is regardless of whether or not the cargo happens?

Yes.

Michael Raab

I mean, there are two different product lines and different patient populations. So our guidance with Enbrel is independent of that. But thanks for asking that.
As it relates to stocking, let me ask Justin to address that.

Justin Renz

And I think at least it has been really a just-in-time on, if you will, approach with explosive. So during up to our network, we've seen very low inventory rates since launch in November. So I would say it is absolutely demand of the patients and not at all any stocking, very limited to roughly between one and two weeks at max in the channel.

Operator

Next question comes from Ryan Desonier with Raymond James.

Please go ahead.

Michael Raab

Hi, this is Ryan Dafna. Congrats on the strong early launch. Two quick questions for me at this point, I was wondering what the breakdown is looking like so far between patients getting access to expose that through Medicare versus non-Medicare? And then comparing the how much of exposes strong start you attributing to differences in market dynamics versus differences in your commercialization strategy? In other words, is your commercialization strategy for exposing markedly different from that of the early Israeli launch? Or is the main driver more related to differences in things like unmet need, patient benefit rate, et cetera?

Yes.

Michael Raab

Ryan, thank you for the question. And the easy answer is, of course, it's our very, very unique and disruptive commercialization approach?
No kidding is. I think what we do here and Susan can address in greater detail that truly is one about having really good drugs that are making a difference for these patients having a commercial team that knows how to communicate that the omni-channel initiatives and remarkable sales team with feet on the ground talking to physicians about what these drugs can do for their patients because these drugs work on Susan.

Susan Rodriguez

So I would say exactly.
And to Mike's point, our go-to-market strategy, actually there are really very important parallels between the drilling and exposure in the novel MOA in the fact that there's limited options and the fact that there's patients in need of novel options. So what where I see where what's an important distinction is that for exposed, we went into the market with a very, very ingoing, high level of awareness, have exposure across the nephrology target base and high interest and intend to adapt and high level of awareness on the range of the patients that they see that they have challenges in managing serum phosphorus and binder therapy. So so I think there is at a higher level of market awareness about both the product and the unmet need, whereas it is rather a while it's a parallel situation where patients have limited options and are inadequately managed and in need of a novel option in our go-to-market approach. It's really our promotion and our education on our target base that really got them to begin to identify while, yes, patients are inadequately managed. We never had another option now that we have another option. We're increasingly identifying these patients. We're actually engaging in dialogue with these patients. And now we're expanding the way we treat and using a roll-up for those patients' anatomy manage. So there is a little bit more market need education required on the Australia side on and that those would be the only differences path to access is the same and the coverage policy that they're being defined or have also been favorable on both sides.

Michael Raab

Got it. And then on the Medicare versus non-Medicare breakdown for the first quarter, Susan?

Susan Rodriguez

Yes, yes. Thank you, Mike. So and right now, it's actually really interesting being on the market now for a full quarter that we can see from our IQVIA data, what the percent mix is for the exposure prescriptions and on average, between 55% and 60% is Medicare and the remainder is non-Medicare.

Got it.

Michael Raab

Thank you very much.
Thanks, Ryan.

Operator

Dennis Ding, Jefferies.

Dennis Ding

Congrats on the solid quarter.
A few questions for me, if I may. On gross-to-nets for exposure, this was definitely better than what people expected in the first quarter. So how does this evolve through the year, and we should use the 23%, 23% as the new base going forward.
And then secondly, I want to take another stab at this question. On HRPP. 24. If the bill is to be signed into law in the first half of 25 expose, I would need to go into that. But then the bill gets signed, exposure would need to come back out of that. But can you perhaps shed some light on that process and from the logistics surrounding that and as I'm going to address that quickly currently, I think as we've said, our intent is to enter into the app.

Michael Raab

I think the specifics of what you're just describing where that's going to play out over time. But our current intent is to go through the process. And as we hope and the work that we're doing and what MoneyCard is doing and others on the Hill is understanding how important medicines for patients. This is the policy that is the right thing to do to ensure that patients get access to a drug that's already beginning to make a difference in many, many lives of dialysis patients. So the work continues and the specifics about how things come in and out based upon these next six months or more, we'll get that to you. As that we also learn adjusted U.S. gross-to-net.

Justin Renz

Thanks, Mike Dennison. The first quarter exposes gross-to-net deduction was 23.8%, and it's obviously very early in the launch and also the first quarter of the calendar year. So as Susan articulated, our Medicare and non-Medicare split is around 55% to 60% Medicare and the rest non-Medicare, we're still learning the patient mix. This is going to drive the gross to net ratio through the course of the year.
So as a reminder, I guess and it's our first full quarter, and we're currently estimating that maybe it will slightly increase over the next few quarters. But in general on, we believe for the rest of this year, it will be in the mid 20s range and we will obviously have an workforce. You have greater clarity.

Got it.

Operator

Next question comes from Rohan or Luis with Leerink Partners.

Please go ahead.

Caitlin Lowie

Great afternoon, everyone. One for expose a could you talk a bit about what the early adopter patients look like in terms of their main features? And it's really encouraging physicians to find them and identify them as optimal candidates for exposure.

Michael Raab

And I'll ask him to address it. But the realities are there now that are define when we know what our two nations are out of range and they've been waiting for something like that. So it isn't the Gematik and fine that you see out past the question again, patients above the answers, of course.

Hugo Ong

Yes.

Michael Raab

And then we move forward on certain scientific.

Susan Rodriguez

Yes. No, no, you're absolutely right now, but I think the analogy in terms of I appreciate your question on you are these early patients were, and I think to Mike's point, first of all, important to know that these phosphorus levels are tracked very closely. So nephrologists have like an ongoing understanding of their patient base and where they're fast versus our. So what we're seeing in terms of the patients that are and are being initiated unexposed right away, are those that the nephrologist had in mind that they know historically, they've really had challenges in keeping them within target ranges that you are getting now. And what's really important is we continue to execute is is now that exposes available to really make sure that the nephrologist begins to adapt their behavior and churn to expose them when possible, looking at their patients that are outside of target ranges.

Got it. Thanks.

Operator

Next question comes from Laura Chico with Wedbush.

Please go ahead.

Susan Rodriguez

Good afternoon.

Caitlin Lowie

Thanks very much for taking the questions. Just two for me first on the rollout, what needs to happen to hit the high end of the guidance range now for 2024? And then I just wanted to follow up on expose the conversation around the current Medicare Medicaid mix. Does that is that where you're projecting at a steady state level, you remain kind of and roughly even split between Medicare and non-Medicare patients. And I'm just kind of thinking ahead in terms of the revenue that might be more exposed to the data environment versus not if you could. Is there any color in terms of where you see that payer mix split ending up over time? That be helpful.

Susan Rodriguez

Thank you.

Yes.

Michael Raab

I mean, just briefly address the Israeli question is it's execution and everything that we have been doing is what we need to continue doing the expanded footprint. Certainly it's going to be a benefit, as we said, a trained and in the field by the end of the quarter. So that's certainly a big part of the two, but it's execution. The patients are there, they're waiting. And when you asked the right questions, that physicians identify them and help them go through the prior authorization process?
Susan, you want address the others, so to your question?

Susan Rodriguez

Yes, sure. So I think it is anything regarding exposure at this moment, only having one full quarter under our belt. It's hard to predict, Laura, you know, I don't want to give you the impression that this is exactly steady state However, it is not unexpected when you are just understanding the patient mix in the dialysis of setting and the mix that we've seen, even you know, for the IQVIA data for the binder therapies. This this is not unexpected, but we need a few more quarters before we can tell you for certain.
One thing that's important is just understanding that the coverage policies have been defined across all payer segments. So I think that's really what driving the ultimate outcome in terms of the profile. And so that is established and we'll be consistent as we move into that as we proceed through this quarter and going forward and because we have nice coverage policies in place across all those segments.

Caitlin Lowie

Thanks very much.

Thank you.

Operator

Joseph Tommy, TD Cowen.

Joseph Thome

And they're Good afternoon, and thank you for taking my question and congrats on the strong launch. Maybe unexposed. Can you give us a little bit idea of the proportion of patients that are on free drug or using the patient assistance program as a way of coverage?
And maybe how long does it take to navigate that prior authorization process from a physician writing a script to them actually getting the drug?
And then second, Mike, you mentioned the cash balance maybe what's your appetite to invest in R&D, either internally or in the pipeline or maybe go externally and bring something?

Michael Raab

And let me address both the first and the last question is we're it's early days for us to be sharing what's on the patient assistance program. So we'll wait until we've got more experience under our belts with that. And you saw just under a month and a half ago, we hired Mike colored her as our Executive Vice President Corporate Development Strategy. That should be the signal to your question. Our willingness to invest and pipeline opportunities, whether it's organic development or opportunities we may find outside as I think what we are demonstrating is that the approach that we take to commercialization of drugs is clearly unique. Our ability to do it attract remarkable performers in the field, I think is evidenced what you see in both Israel and expose performance. So leveraging that and bringing Mike on board certainly is a big part of us going in that direction.

Joseph Thome

Great, thanks.

Operator

Ed RC, H. three rain.

Right, please go ahead.

Operator

Hi, everyone.

Hugo Ong

This is Thomas Yip. Asking a couple of questions for Ed. Congrats on the strong early traction with the disposal. And perhaps first question, can you discuss how many patients are on drug for the priority to beta and among these patients, what's the split between GR gastro and then PCP subscribers? And then I have a follow-up question as well.

Michael Raab

It's little bit hard to hear the question, but I think you're asking about the split of patients in the GAs versus PCPs. I think as Susan has spoken about our targets, it's higher writing GI.'s and high writing HCPs who act as other TKIs and Epic practices. I don't know, Susan, if you want to add anything more to them.

Susan Rodriguez

Yes, exactly. So we identify you know, our target audience is 9,000 HCPs that account for 50% of the total IBS-C indicated market. So even though so many doctors write IBS-C scripts and this the opportunity of really targeting this concentrated group. That accounts for 50% is really what drives this upsell opportunity for us. And as Mike mentioned, the what we find is that there really isn't a distinction between IPCP. and IGI. what we have is Yes, hi, writing GI.'s. And then we have high writing non-GAAP and actually you know behave like Jive and just decide to take an interest in treating IBS-C and using the IBS-C indicated drug to manage their patients. So and so it's really not a distinction that's relevant in our go-to-market approach.

Michael Raab

Got it out.

Hugo Ong

And also, can you discuss how many patients are on explosive for efficacy data and also the script data, it can be a reasonable indicator of underlying demand?

Michael Raab

Well, I think you're asking how many people are on 60 day versus 30 day scripts. I think, again, it's early days for us to be sharing that kind of information.

Operator

The next question comes from Matt Kaplan with Ladenburg Thalmann.

Hugo Ong

Please go ahead and guys, thanks for taking the question and nice nice out of the gate launched direct. So there's a graph there. Some Just wanted to dig in a little bit more to Axalta's performance during the quarter. I guess what that could mean for demand and 2024 and beyond. But I guess, especially given the high levels of interest you're seeing this year ex survey And were these initial doctors kind of adopters that really taking on new therapies and then it will be more difficult to get additional doctors down the line because these are the early on a new therapy interest there.

Michael Raab

A quick comment, and then I'm going to address in more detail is nephrologists have been trying their entire careers with these patients to get their serum phosphorus levels in check, and they have been willfully unable to have a single mechanism of action of binders irrespective of the type binder that it is. Patients don't want to take that amount of material, low cost per suite or unpalatable it's really difficult life. And when a new mechanism of action like this comes in and as Susan spoke in, our opening statement about how this is being utilized along exactly what the votes were in our AdCom is really heartening. And I think physicians see the opportunity to finally have a tool in their toolkit that may help their patients get into the target range that they've been trying to do. And as Susan said, also in our opening comments that we are hearing from patients and from physicians that these effects are sustained and that's heartening and extraordinarily rewarding that we're going to have that kind of impact on patients. It is early days. You always are going to have early adopters, right? That's not an uncommon phenomenon. But the difference here because there's not one nephrologists out there that have not struggled with normal one patient out there that is not struggled with how to manage serum phosphorus.

Susan Rodriguez

Susan, anything to add, would you say this very stated did report a 56% user base and that data that was generated in April. So and what we're seeing in the field is that nephrologists really want to spend time with our sales team. We're getting in to these offices. They're learning about it and they do have patients in mind once day, they are detailed unexposed. So I think it's more around it's not around an early adopter profile as much as every doctor to Mike's point has been in managing this challenge of getting these phosphorus levels within target ranges with the limited options they have and now are very open to incorporating expose into the treatment regimen to trying to do better so I think that that's pretty common across all the nephrologist where it's going to be important to continue to move the uptake is to expand their thinking where it's not just that patient that they've always had in mind has been so challenging. But now that you have a new tool, as you see, the phosphorus is every month, you know, don't wait for our multiple reads are trying to make everything work for them on diet or other things. The things that they've struggled with now they should treat these patients because of the expanded treatment armamentarium they have with exposure. So that's what's going to be important is just moving beyond first cohort of patients that they clearly were waiting for something new and now you know, adapting their practice to having a blocking mechanism drug-like both.

Hugo Ong

Thanks, guys. That's really helpful.

Operator

This concludes our question and answer session. I would like to turn the conference back over to President and CEO, Mike Rob, for any closing remarks.

Michael Raab

Thank you, everyone, for joining us this evening, including our investors who've been on this journey with us, the employees who drive our success, our partners who support us and the patients that we serve.
With that, we can close the call. Operator.

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.