Thank you. Good morning, everyone, and welcome to our call. Yesterday, we issued a press release announcing the FDA approval of XPHOZAH and a second press release announcing an amended loan agreement. During this call, we will refer to the press releases, which are available on the investor section of the company's website at ardelyx.com. 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 most recent quarterly report on Form 10-Q that was filed in August, and can be found on our website at ardelyx.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.
During today's call, we will have prepared remarks from Mike Raab, President and CEO, Dr. David Rosenbaum, Chief Development Officer, Susan Rodriguez, Chief Commercial Officer, and Justin Renz, Chief Financial and Operations Officer. Rob Blanks, Chief Regulatory Affairs and Quality Assurance Officer, and Dr. Laura Williams, Chief Medical Officer, will join us for the question and answer period. With that, let me pass the call over to Mike.
Thank you, Caitlin, and good morning, everyone, and thanks for joining today's call. This is a very big and remarkable moment for Ardelyx, but especially for CKD patients on dialysis with hyperphosphatemia. At approximately 5:00 P.M. yesterday, we received notice from the Food and Drug Administration that tenapanor, which we have branded as XPHOZAH, is now approved. This achievement is the culmination of more than a decade of discovery, development, and diligent execution by the talented team here at Ardelyx. I couldn't be more humbled and more proud. I'd like to take a moment to recognize our founders, Dominique Charmot, Pete Schultz, and Jean Fréchet, who back in 2007, had the vision to create a company whose objective was to develop a small molecule approach to managing elevated serum phosphorus in dialysis patients. The approval of XPHOZAH has been a long-anticipated and long-awaited milestone.
It is a momentous day, not only for Ardelyx, but for patients, their families, caregivers, and the entire nephrology community. Yesterday's approval of XPHOZAH marks a new era for kidney community and advances the care of hyperphosphatemia. For the nearly 80% of patients who, despite treatment, are unable to consistently meet and maintain the globally recognized target levels of serum phosphorus, XPHOZAH is now an option. We are now preparing to get this important medicine into the market as quickly as possible. Susan and the team are mobilizing, and we expect to have XPHOZAH at our distributors in November. As we did with IBSRELA, a key focus for us will be ensuring that patients who are prescribed XPHOZAH have access to the treatment.
We will integrate XPHOZAH into our best-in-class comprehensive patient services program, ArdelyxAssist, which is designed to support patient access independent of insurance coverage or affordability challenges. Susan will share more details on this program in a few minutes. This is an incredible moment for Ardelyx. We were founded with a mission to discover, develop, and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. With the approval of XPHOZAH, we mark the second time that we have delivered on that mission and achieved an achievement rarely seen, especially by a biotech company our size. We launched IBSRELA for patients with irritable bowel syndrome and constipation just 18 months ago, and in November, just a few weeks from now, we expect that CKD patients will have access to XPHOZAH. I want to thank the incredible team at Ardelyx who have worked tirelessly to get to this day.
For those of you who have followed us, you know we would not have achieved this milestone if it were not for the support of the families, patients, caregivers, healthcare providers, and supporters of the kidney community. They have stuck by us, believing in the value that XPHOZAH offers as another option for patients in the fight against hyperphosphatemia. That especially includes the more than 1,000 patients who participated in our clinical trials and the researchers and care teams that supported them. To each person who has been involved over the past decade, I extend my sincere gratitude and thanks.
Having devoted much of my career to the cardiorenal field, it is especially gratifying to gain approval for XPHOZAH, which I believe will be a transformational therapy for many CKD patients on dialysis who have been unable to achieve serum phosphorus control, no matter how hard that they have tried. We are providing physicians and patients with a differentiated treatment option in a therapeutic category where there has been no meaningful innovation in decades, resulting in significant unmet needs and pent-up demand. I will now hand it over to David, who will discuss the comprehensive clinical development program that supported the approval of XPHOZAH and its label. Next, Susan will review the favorable market dynamics and Ardelyx's commercial strategy. Finally, Justin will share details of the announcement we made yesterday regarding the debt financing amendment, which further strengthens our cash position and supports the launch of XPHOZAH.
What you will hear is that we have the experience, the capabilities, and the tremendous dedication of our organization in place, and we are eager to ensure a successful launch. David?
Thank you, Mike. Approval of tenapanor, now branded XPHOZAH, is truly a rewarding milestone as this innovative therapy will now get to patients who truly need it. Before I get into the clinical data and label, I would like to take just a moment to reflect on this achievement. I've overseen the development of XPHOZAH for the past 13 years. I was involved in discovering the molecules in our lab, developing it into a drug, and testing it in an extensive non-clinical and clinical development program. But taking a step back, I have been involved in developing products to help CKD patients on dialysis with hyperphosphatemia for a large portion of my career. Over 25 years ago, I worked on the development of sevelamer at Genzyme. That's where I met Mike.
When presented with the opportunity to work with Mike on a minimally absorbed small molecule, the treatment of hyperphosphatemia, I jumped at the opportunity. I knew, based on firsthand experience with phosphate binders, that creating a one small pill twice a day therapy could change the paradigm of treating hyperphosphatemia and improve the daily lives of CKD patients on dialysis. It's been a long, sometimes arduous path to this day, but we have never wavered in our desire to get this drug to the patients who need it so badly. To see its approval is a major achievement for the entire Ardelyx team. XPHOZAH, with its novel mechanism of action that blocks the absorption of phosphorus through the primary pathway of phosphate absorption, brings a significant advancement to patients with CKD on dialysis. I agree with Mike, this is a new era in the treatment of hyperphosphatemia.
XPHOZAH is a first-in-class, minimally absorbed oral medicine indicated to reduce serum phosphorus in adults with CKD on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH has a unique mechanism of action as the first and only phosphate absorption inhibitor, or PAI, that blocks paracellular phosphate absorption via local inhibition of the sodium hydrogen exchanger 3. I emphasize this differentiated mechanism because this is at the crux of what we do at Ardelyx. We discover and develop first-in-class novel mechanism products where there is a significant unmet medical need, and there is a significant unmet need when it comes to hyperphosphatemia. Historically, the only treatment option to manage serum phosphorus relied on the binding mechanism, which hasn't been sufficient to achieve guideline-established target levels for the majority of patients.
In fact, patient chart audit data demonstrates that in a 6-month period, 77% of binder-treated patients are unable to consistently maintain a serum phosphorus level of less than or equal to 5.5 mg per deciliter. With our approval notice, we received the package insert for XPHOZAH. I want to express how satisfied we are with the final package insert language, which is reflective of our comprehensive development program and the need for additional therapies in this space. The FDA approval is supported by numerous non-clinical studies, greater than 20 clinical trials, and a comprehensive data package involving a diverse population of more than 1,000 patients in three phase III clinical trials demonstrating the efficacy and safety of XPHOZAH. All three of these phase III trials and 6 additional clinical trials have been published in peer-reviewed journals.
Two of the trials, BLOCK and FREEDOM, evaluated XPHOZAH as monotherapy, and one trial, AMPLIFY, evaluated the effect of a dual mechanism approach utilizing the novel blocking mechanism of XPHOZAH together with phosphate binders. I'll quickly highlight key findings from these trials. In both monotherapy trials, BLOCK and FREEDOM, XPHOZAH met its primary endpoint by showing a statistically significant difference in serum phosphorus between the XPHOZAH-treated group and the placebo-treated group, with P values of 0.01 and less than 0.001, respectively. In the AMPLIFY study, which evaluated patients who remained on phosphate binders during the study and who were uncontrolled with a serum phosphorus greater than or equal to 5.5 mg per deciliter, patients treated with XPHOZAH had a statistically significant mean reduction in serum phosphorus as compared to placebo, with a P equal to 0.0004.
Up to 49.1% of patients in the XPHOZAH plus binder arm achieved a serum phosphorus of less than 5.5 mg/dL, which was statistically significant as compared with up to 23.5% in the placebo plus binder arm, with P values ≤ 0.0097. As noted in the label, the only adverse reaction reported in at least 5% of the patients treated with XPHOZAH in our phase III trials was diarrhea, with an incidence that ranged between 43%-53% of patients. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild to moderate in severity and resolved over time or with dose reduction. Diarrhea was typically reported soon after initiation, but could occur at any time during treatment with XPHOZAH.
Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials. These data support the indication for XPHOZAH, which, as I said, is to reduce serum phosphorus in adults with CKD on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH will be available in 30 mg tablets, with patients able to titrate down to 20 mg tablets. This label will give the nephrologist community access to greater flexibility in how they can treat their patients. XPHOZAH addresses a critical need among this patient population with another option to help patients reduce their serum phosphorus. In addition to our phase III trials, we conducted an open-label trial, optimized to help nephrologists integrate XPHOZAH into their clinical practice.
In OPTIMIZE, patients on a phosphate binder with uncontrolled serum phosphorus, defined as greater than 5.5 mEq per deciliter, had XPHOZAH added to this treatment regimen. The binder treatment was then either reduced by 50% or completely removed. In this patient population, 38% and 34% of patients treated with XPHOZAH and a binder, respectively, were able to achieve target serum phosphorus goals. Overall, 84% of patients who reported an improvement in their phosphate management routine. During the past 10 years, I have traveled to numerous dialysis centers around the country and had the opportunity to speak with many patients and their care teams, physicians, advanced practice providers, dieticians, nurses, and dialysis technicians. There has been universal support for our work and a deep desire to have another mechanistic option to treat hyperphosphatemia.
The approval of XPHOZAH is an incredible milestone on the journey we have been on alongside many members of the kidney community. This is why we are so pleased to bring XPHOZAH, its new mechanism of action and its comprehensive data package to nephrologists and advance the treatment of hyperphosphatemia. With that backdrop, I will now turn the call over to Susan to review our commercial readiness and launch plan. Susan?
Thank you, David. Before I turn to market readiness and launch plan, I want to express my deep appreciation to the team at Ardelyx that led the discovery and development of XPHOZAH. Based on our research expertise in characterizing the paracellular pathway as a primary mechanism of phosphate absorption, we have innovated and now achieved approval for a first-in-class phosphate absorption inhibitor. We are thrilled to bring this innovation to the kidney community. This approval begins a new chapter in the management of hyperphosphatemia for patients. XPHOZAH, with its unique mechanism of action, brings a novel approach to a therapeutic area that has not seen meaningfully differentiated innovation for more than 30 years. The launch of XPHOZAH now provides nephrologists with an expanded treatment armamentarium that will enable them to advance patient care. The market dynamics are favorable.
Hyperphosphatemia is a well-established therapeutic area with treatment goals centered on globally recognized treatment guidelines. 80% of the estimated 550,000 patients with CKD on dialysis in the U.S. are treated with a prescription therapy in an effort to control their elevated levels of serum phosphorus. Prior to yesterday's approval of XPHOZAH, there was only a single class of agents available to treat hyperphosphatemia, phosphate binders. Despite widespread use of these agents, the majority of patients have been unable to consistently achieve and maintain guideline-established serum phosphorus levels. Patients who are intolerant to any dose of a binder therapy have had no other option. The market is primed and ready for XPHOZAH.
According to our research conducted earlier this year, nephrologists struggle to keep their patients' phosphorus levels in range, with 40% of surveyed nephrologists reporting that current treatment options are not satisfactory and 69% of nephrologists reporting a high or very high need for a new treatment option. Awareness of XPHOZAH is high. Among nephrologists who reported being aware of new treatments for hyperphosphatemia, 75% mentioned tenapanor by name. The appeal of XPHOZAH is also high. Nephrologists rate the novel mechanism, efficacy, tolerability, and dosing attributes favorably, and 59% reported that they intend to adopt XPHOZAH within the first six months of product availability. The market is eager for a new entrant, and Ardelyx is well positioned to capitalize on this opportunity.
We have deep and proven commercial capabilities to bring our innovations to market, to disrupt markets, and to advance treatment patterns with the integration of our novel therapies. We launched our first commercial product, IBSRELA, for the treatment of IBS-C in the first quarter of 2022. The successful launch and early uptake of IBSRELA has been driven by the innovative product profile, our strategic capabilities, and a strong commercial execution focus, all of which will also be driving forces for a successful launch of XPHOZAH. The commercial strategy of XPHOZAH centers on three key elements. First, a novel treatment option. XPHOZAH is not a binder. It is a first-in-class phosphate absorption inhibitor. This is a significant innovation for patients who, up until now, have only had one treatment option for managing hyperphosphatemia. Second, patient need for innovation.
The vast majority of the 550,000 CKD patients on dialysis who are treated with a phosphate binder are unable to consistently achieve or maintain target phosphorus levels. Third, patient access to treatment. Supporting the prior authorization process that is customary for a novel therapy entrant and supporting patient affordability to provide patients in need of treatment with XPHOZAH to make sure that they have access to XPHOZAH.... These three core elements are foundational to our go-to-market approach, which centers on enabling nephrologists to integrate first-in-class phosphate absorption inhibitor, XPHOZAH, into the treatment regimen of their binder-treated patients who have had an inadequate response or cannot tolerate any dose of binder therapy. Key launch initiatives align with these core foundational elements.
We have built a nephrology sales force sized at 60, dedicated to cover the approximately 8,000 nephrology healthcare providers who write the majority of the hyperphosphatemia prescriptions. A successful commercial track record for Ardelyx, combined with the market enthusiasm around first-in-class XPHOZAH, has attracted best-in-class talent and experience. A team of highly seasoned, knowledgeable, and driven individuals is in place and ready to begin engaging with the prescribing community. Our distribution network is also in place and will provide full coverage across the U.S., aligned optimally to our access strategy. We will also have a strong commercial and scientific presence at the American Society of Nephrology's annual conference, taking place in a few weeks in Philadelphia. The positioning for XPHOZAH will center on integrating a novel blocking mechanism therapy for their binder-treated patients who have an inadequate response or are intolerant to any dose of binder therapy.
For these patients, nephrologists can now start blocking. On the access front, we are engaged with the prescription market payers to educate them on XPHOZAH, the novel mechanism of action, the clinical data package, and now the approved label. We anticipate that coverage policies will characterize the path to access based on a prior authorization criteria. Patients will meet this criteria, as so many are currently treated with binders and not responding adequately or not able to tolerate binder therapy. Our comprehensive patient services offering, which includes prior authorization, support, and follow-up, a co-pay program for patients with commercial coverage, and a patient assistance program with broad eligibility criteria, will work to optimize patient access. It is possible that the payer landscape for Medicare patients could change if current provisions on the addition of oral-only medicines into the Medicare ESRD prospective payment system are not delayed.
There are comprehensive efforts across all key stakeholders to delay this provision to 2033, and we will keep you apprised as to how the payer landscape for Medicare patients evolves in the context of our ongoing commitment to optimize patient access to XPHOZAH. In summary, today starts a new era for patients with CKD on dialysis with hyperphosphatemia. Patients who had an inadequate response to binder treatment now have a new add-on option, and patients who are intolerant to any dose of a phosphate binder have the opportunity to be treated with a new therapy. There is high awareness and anticipation to adopt XPHOZAH. It is poised for rapid market uptake, driven by our team's focus on enabling the nephrology community to now integrate XPHOZAH into their treatment armamentarium. The future is bright for Ardelyx. This marks the second commercial launch for our company within a 2-year time frame.
Our strategies and capabilities disrupt markets and advance care with the introduction of novel products. We enter this prime hyperphosphatemia market with a much-needed new therapy, an experienced and talented team to support it, and with a clear commercial pathway, with no additional novel entrants expected to launch across the XPHOZAH patent landscape. I will now turn the call over to Justin.
Thank you, Susan. As others have already said, this is a milestone day. In addition to announcing the approval of XPHOZAH, we also announced via press release last night that we've amended our loan agreement with SLR Capital Partners or Solar. The loan agreement amendment provides Ardelyx with access to up to $100 million of committed funds, which includes $50 million in the existing facility, as well as a new commitment of $50 million. This amendment further strengthens our cash position, and we believe we are well-resourced to support the commercialization of both XPHOZAH and IBSRELA. We currently have $27.5 million of debt on our balance sheet, reflective of the first tranche of capital that was drawn back in February of 2022.
We expect to draw the second tranche of $22.5 million, also from the original commitment, later in October. But in terms of the amendment, we now have the option to draw a $50 million third tranche under the facility until March 15th, 2024. And in addition, we can elect to borrow an additional fourth tranche of up to $50 million, subject to SLR credit approval. The interest-only period for any drawn funds associated with the facility has been extended to December 31st, 2026, contingent upon us drawing the second $22.5 million tranche, which, as I said earlier, we expect to do later this month.
While the capital provided by SLR strengthens our cash position, our financial discipline over the past few years, as well as our general approach to financing, have set the foundation for our future. IBSRELA's performance since launch reflects the impact of our ongoing investment. We have built a strong commercial presence for XPHOZAH, and the team is ready to engage with the prescribing community. We are also continuing our investment in our best-in-class patient services program to ensure that access and affordability do not limit patients who prescribe XPHOZAH from getting their treatment. We will enter 2024 commercializing two products and investing in the future of Ardelyx. Those efforts will be funded by our current cash position, as well as milestone payments from Kyowa Kirin and HealthCare Royalty Partners, following last month's approval of tenapanor hyperphosphatemia in Japan.
A milestone payment associated with the NDA submission of tenapanor hyperphosphatemia in China, which we announced in July, and the additional $22.5 million in debt financing that we expect to draw later this month from the SLR agreement. We look forward to sharing our third quarter results in two weeks. The approval of XPHOZAH, the commercial success of IBSRELA, and our current cash balance places Ardelyx in a position of strength to fuel future growth and deliver value to our shareholders. I will now turn the call back over to Mike for some concluding remarks. Mike?
Thanks, Justin. With the approval of XPHOZAH, we have yet again delivered on our commitment to patients to discover, develop, and commercialize first-in-class therapies. We are eager to get XPHOZAH into the hands of patients. This launch is the utmost priority for all of us at Ardelyx, and we clearly have the team to ensure its success. While we launch XPHOZAH, we remain laser-focused on ensuring that IBSRELA gets to the many IBS-C patients who are in need of meaningful benefits IBSRELA provides. Over the next few months, we will begin working on the next phase of Ardelyx's evolution. This will include restarting a number of our pipeline programs, looking to in-license programs that would benefit from our targeted and thoughtful commercialization capabilities, continuing to support our international partners, particularly Fosun Pharma, as we await approval of tenapanor for hyperphosphatemia in China, and identifying partners in open territories.
We look forward to keeping you updated on our progress, including our third quarter performance, which, as Justin just mentioned, we will announce on October 31. With that, I will now open the call to questions. Operator?
Thank you. We'll now begin the question and answer session. To ask a question, you may press star, then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then two. At this time, we'll pause momentarily to assemble our roster. Our first question comes from Chris Raymond from Piper Sandler. Please go ahead.
Hey, thanks, guys, for taking the question and, congrats. Really one of the most amazing stories of perseverance I think I've seen actually in the space. So congrats to you guys for all this. I guess a couple questions. I didn't hear any mention of price. So I guess first and foremost, can you give us a sense of the pricing strategy? And is this something that you're planning to announce as you get closer to launch? And then maybe, more broadly, you know, on you know, the prior auth process, you know... So, with the labeling language around inadequate response and intolerance, there seems to be some sort of, I would argue, gray area, you know, in terms of defining both.
You know, you guys mentioned a lot of the data. I think this is from Spherix, with, you know, a third of patients at any point in time or at that snapshot being inadequate responders, but over 70% of patients over the last six months being inadequate responders. How do you think payers will define, you know, sort of that part of the label in terms of being, you know, inadequate responders, or for that matter, intolerant of treatment? You know, one would argue, like, with that pill burden, everyone's intolerant. So how do you anticipate the interpretation of that?
Sure. Hi, Chris. Thanks for the comments, too. It has been a remarkable journey for all of us, and we're really excited about getting exposed to out to patients. As it relates to price, you know, we wanted to wait and see the final language in the label to dot the I's and cross the T's. Our expectation is when we talk about earnings on the 31st, that's when we would tell everyone what the price is that we are going to come to. So no magic around it. We just want to make sure that we do all the work that we need to do. I'm going to ask Susan to address your questions on prior authorizations, but I think really you hit the nail on the head.
But for one thing, it's not really the payers that are going to determine those things. It's going to be the physicians who determine with their patients what's intolerance, and insufficient. But the process that Susan and team have put in place to facilitate going through, I'll ask Susan to address.
Yes. Hi, Chris. Now Mike is exactly right. And actually, we have been actively engaged with all of the payers, educating them on the profile of XPHOZAH, and they are quite aware of the limited options to date available to these patients, the globally accepted guidelines on target levels, the fact that despite treatment, patients, you know, persist in not being able to maintain those target levels. And really recognize the value of a novel mechanism drug like XPHOZAH. And now with the indication, you know, being indicated for that group of patients, binder-treated patients who have an inadequate response or intolerance, we are now the only choice for that group of patients, which the payers recognize is a sizable group and one that's in need of a novel therapy. So, we're in a good position.
We anticipate that they will begin publishing their coverage policies over the next
... several months. The drug will be available via prior authorization, and as you know, patients' phosphorus levels are, you know, are monitored frequently. Physicians are quite aware of patients who are inadequately responding. So that will be a very straightforward prior authorization criteria to submit. And on the tolerance level, again, that's a physician attestation and a physician call, as Mike mentioned. So, so we see really, a very smooth path to access for XPHOZAH. It's going to require the prior authorization. Physicians are going to need to commit to that administrative process. However, physicians see that the patients meet the criteria, so they're motivated to do so. And, the nephrology space, they're quite accustomed to submitting prior authorizations to give their patients access to new therapies or branded therapies.
So we see that as an actually a, you know, a positive aspect of the overall projected uptake for XPHOZAH.
Okay. And if I can ask a follow-on question real quick. Susan, you mentioned, you know, sampling as part of the, you know, the standard procedure here. Just kind of give us a sense of how much you anticipate, maybe for the average center or large volume practice you'll need to sample in order to get them to convert to regular use.
Yeah. So obviously, it's a core component to our overall promotional presence in the space. We will be focused on the nephrology call point and nephrology offices, and obviously, we'll have samples available. We're not going to get specifics on the overall volume. It's a piece of the overall picture in terms of giving physicians an opportunity to start patients on XPHOZAH and see how they do as they write their prescription in parallel. I mean, that's the way we always execute, you know, because patients who need XPHOZAH need to be prescribed XPHOZAH, and the sooner we can start working through those prior authorization processes, the better for the patient to receive XPHOZAH.
Okay. Thank you.
The next question comes from Louise Chen from Cantor. Please go ahead.
Hi, congratulations on all the great news and progress here, and had a couple questions for you. So I wanted to ask you, how much inventory have you built for the launch? Do you think this will be a, a slow, medium, fast uptake, especially as we head into the end of the year? And then for ASN, what kind of activities are you planning around this launch for XPHOZAH? Is it going to be a launch event for you, or, you know, what are you thinking there? And then last question is just, you know, congratulations on this debt financing. How does that add to your current cash runway? Thank you.
Thanks, Louise. Let me have Justin address the first and the last first, and then we'll have Susan talk about ASN. But, you know, we're not going to get into the specifics about the amount of inventory. Remember, the active ingredient is the same for IBSRELA and XPHOZAH, and I can assure you that for both, Justin and the manufacturing team have made more than sufficient, and we have no issue with the amount of inventory that we have. Justin?
Just to elaborate briefly, Louise, on what Mike just said, we are in great shape. We, as you've seen from our earlier financial statements, built inventory up over the course of the year, and we are well resourced for both IBSRELA and XPHOZAH going forward. We are working as a team now to get inventory in the channel to be available for the nephrology community as soon as possible. We're in great shape, into the rest of this year and well into 2024. Regarding the cash balance, you know, we'll share our cash position when we give our Q3 earnings on Halloween, but I can give you a brief update of kind of where we are. We finished the second quarter, as you may recall, with approximately $130 million in cash.
Today, we announced that we plan on taking the additional $22.5 million later this month. Between June 30s and today, we also received approximately $35 million from our partners, Kyowa Kirin and HealthCare Royalty Partners, as well as $2 million from a milestone we achieved from our partners in China. We are well-resourced in a great cash position right now, and we'll give you obviously more specifics on October 31st.
For ASN, Louise, we will have a very strong presence at ASN. It is a completely mobilized new product launch. We have very, very good booth position, strong booth presence, and, you know, commercial launch branding, all will be present there. You know, quite visible at ASN. We have our fully trained nephrology sales team will be there to engage with their nephrology contacts. We will also have, you know, a spotlight series, so we'll have our, you know, opinion leaders presenting on the clinical data for XPHOZAH and the importance and the high unmet need in this space, you know, to integrate a novel blocking mechanism therapy into their daily treatment regimen for the binder-treated patients. That will all be very visible at ASN.
In parallel to that, we will have a strong scientific presence with abstracts, posters, and a strong medical affairs presence as well. So, we're very enthusiastic about our readiness for the full launch of XPHOZAH at ASN. The timing could not be better, given our approval and this meeting being a few weeks from now in Philadelphia.
Thank you very much.
The next question comes from Dennis Ding from Jefferies. Please go ahead.
Hi, good morning, and congratulations on the approval. Two questions from me. So, as you guys are launching XPHOZAH and, you know, 2024 is going to be a really big year for the company, how do you think about the launch curve, and importantly, what gives you the confidence that the XPHOZAH launch would do better than some of the prior comps in the hyperphosphatemia space? And I'm thinking about Auryxia and Velphoro. And then number two, there's been a lot of industry news and developments around GLP-1s, and Novo obviously had some positive developments in CKD.
...What is your messaging to investors on GLP-1 and the impact to the dialysis market, specifically hyperphosphatemia? Thank you.
Hey, Dennis. Thank you. As it relates to the launch curve, you know, I think we should all be thinking about the information that Susan shared as to the pent-up demand, both from our market research and from Spherix. You know, questions were very, very similar when we launched IBSRELA as to why and how would we have a launch curve that was different than the previous ones for IBS-C. And I think what we've demonstrated is that the approach that we take, which is totally different, has resulted in what everyone has seen with the IBSRELA performance. There's no reason to believe that XPHOZAH is going to be any different than its success, given the pent-up demand, and the need that's clearly out there. So we're not going to give any specifics yet.
You know, as we did with IBSRELA, we wanted to wait, you know, 5+ quarters before we were firm in giving guidance and specifics like that. So we'll probably follow a similar pattern with this, just because we want to make sure that we're giving you real, actionable, and important information. You know, the Novo results from the FLOW trial, I think, are spectacular, in that it's good for patients. What I'd like to do is ask Dr. Williams to address that a little bit in her view of those data. And any sort of impact it has for us is not anything that we're concerned about, because anything that's good for CKD patients is the right thing that we should be doing and focusing on. And that's the way that we consider it. Laura?
Yeah, absolutely, Mike. I think, we all applaud the results that we saw from the FLOW study. I think it's important to remember that diabetes was the eighth leading cause of death in 2000 and remained the same in 2019. It also remains the leading cause of end-stage kidney disease, and the incidence and the prevalence of both diseases remain high. And so any efforts to slow the progression of kidney disease are absolutely essential, and that should remain our primary focus. That said, simultaneously, I think we have to do everything we can to address the unmet need that exists today among dialysis patients, and that's our focus.
Okay, thanks, guys. Congrats on the approval.
Thanks, Dennis.
The next question comes from Yigal, from Citigroup. Please go ahead.
Yeah. Hi, Mike, David, Susan, Justin, and the whole team. Congrats on this really, really tremendous milestone. I just had a question on the use of XPHOZAH. Obviously, the label is indicated for add-on or for those intolerant, but after all, as David highlighted, two of the three approval trials were monotherapy. So would you expect any monotherapy use, perhaps in patients that are not intolerant to the binders, but the physician deems them close to goal, and they're not interested in the pill binder burden, so perhaps they would be a good candidates for monotherapy?
Sure. Thanks, Yigal. You know, you hit the nail on the head. We feel that this indication is right on the line with what we expected. What I'd like to do is ask Laura, again, to address, as a clinician, looking at that indication statement, sort of the variety of how one would look at treating patients with XPHOZAH.
Yeah, I think one of the things Mike alluded to before, Mike and Susan, was that shared decision-making process that happens between the patient and the prescriber. And so, you know, as you look at the indication and you look at patients who are intolerant to phosphate binders, and intolerance is defined again, by that patient and that physician in their shared decision-making, that would be a patient that obviously would be eligible to use XPHOZAH. And so I think there are myriad numbers of ways that we would, you know, see this, that actually align with the label. You know, our OPTIMIZE data looked at different ways in which we could integrate XPHOZAH into a treatment regimen. We certainly would do that in line with what the label has indicated.
And that allows you, Yigal, for monotherapy for those patients who can't tolerate any binder. Right, so I think it covers all aspects of the way you would do that. The one thing, as we have said all along, the likelihood of this being used in naive patients, given payer dynamics at a minimum, is not part of what we expected, nor I think is what anyone expected.
Okay, thanks. And Mike, and Justin, I believe in the past, for IBSRELA, you had outlined that the drug could be $500 million at peak in the US I'm just wondering if you could make any comments or if you're prepared to make any comments about how you see the peak sales for XPHOZAH in the US market. And then obviously, now that you have two commercially approved drugs, and you're gonna generate more cash, do you have any early thoughts on timelines to profitability? Thanks.
Thanks, Yigal. So we're not yet prepared to provide some of those perspectives in terms of what peak would look like. Give us some time for that. And, as it relates to having two products on the market, Justin, why don't you?
Yeah, thank you for asking, Yigal. Unfortunately, we're not at a point where really we can share what the breakeven point is. As I mentioned earlier, we're very well, well-resourced at this time, and-
... We're very excited about the opportunity now that XPHOZAH is going to be made available in the United States, that with revenue for both products in 2024, we will be obviously getting closer and closer, and we're really well funded now in light of our recent financing we just announced. But unfortunately, I, I don't think it's fair for us to give you a specific date of when that breakeven point might be. But we will keep you informed, and again, we expect to have more information on our earnings call in two weeks.
Okay, thank you.
The next question comes from Laura Chico, from Wedbush Securities. Please go ahead.
Good morning. Thanks very much for taking the question. So, I guess first, following up on the question just regarding phosphate binder launch curves. I guess, just to be clear here, does your thesis on a different launch curve for IBSRELA, or I'm sorry, XPHOZAH, have more to do with your sales deployment strategy, or is it that this is a different mechanism of action? I guess I'm trying to understand what you think might be the bigger lever here on uptake.
I would say yes to both. You know, those are two of the incredibly important components of what makes this different. But let me ask Susan to address it in more detail.
Yes, Laura. No, I think you're spot on. I mean, the, the marketplace has never seen a mechanism that's novel, versus existing phosphate binders. And, if you think about the binder-treated patients today, either inadequately responding to the binder therapy or intolerant to any dose of binder therapy, there is a role for a blocking mechanism drug across those patients. And that's, that's a broad range of patients. So the, the versatility that this provides the prescribing community now for their binder-treated patients is, is really remarkable and why it's not comparable to, to launches we've seen in the past on drugs that were mildly differentiated within the binder class. This is a first-in-class mechanism drug with this novel blocking mechanism. So it will have its, its unique uptake curve that's lined up with the patients who are very much in need of that therapy.
Combined with our proven track record in terms of strategic planning on the commercial launch and commercial execution, and supporting those physicians with our patient services to navigate those prior auths and making sure to optimize patient access to XPHOZAH. So all those things really will lead to a unique uptake curve, specific to the needs of this patient population and what XPHOZAH brings to the market.
Okay, thank you. And then maybe just one quick follow-up. The Kidney PATIENT Act legislation, you mentioned that. I believe there's an additional co-sponsor that was added to the bill, and obviously, there's a little bit of gridlock in Congress right now, but what are your expectations with regard to potential timing on the bill? Thanks very much.
One of the things I think we've learned, Laura, is predicting what happens in the government is a really bad idea. You know, the fact that this bill is there and that Don Davis now also signed on as a co-sponsor, I think speaks to the enthusiasm of making sure that we're doing the right things for patients. So, you know, we will continue to watch that and participate in any manner that we can and keep everyone apprised as things progress. You know, Congress getting back into the work of doing the job they're elected to do is certainly the thing that we want to make sure that these patients get what they deserve.
Thanks very much.
Thanks, Laura.
The next question comes from Ed Arce from H.C. Wainwright. Please go ahead.
Hi, everyone. Thanks for taking my questions. And let me add my congrats on the long-awaited approval of XPHOZAH. So, first for me, I think Susan mentioned that you are now poised for a rapid market uptake. I wanted to just ask about the expectations around initial market channel stocking and that dynamic, what you expect there, and also around the prior auth. You know, what kind of impact could that have in terms of the initial uptake delay? Just trying to get a sense for the first, probably first few quarters of sales. Secondly, around the Medicare landscape, as you mentioned, you know, the oral bundle and the impact that could happen there from action at Congress.
I'm just wondering if you could remind us what percentage of patients are on Medicare and what proportion would you expect to be part of your commercial group? And then lastly, I'm just wondering, you know, given the debt financing amendment, if you could remind us, along with that, you know, overall picture of your finances, what are the near-term milestones from Kyowa Kirin? Thanks so much.
Sure. Let me address the first part first is, you know, we have all, I think, learned is, you know, shipment to distributors is mostly just in time. So, you know, we're not going to give any specifics as to what stocking is going to look like. You know, that will become clearer as we talk about our fourth quarter earnings in Q1 of next year. Let me ask Susan to address your questions around the percentage of patients on Medicare, and then Justin can address your financial questions.
Sure. So, interestingly, it's actually a pretty difficult number to nail down because of the dynamic nature of these patients. They enter into dialysis with their current payer structure and then ultimately become eligible for Medicare. So there's multiple sources that point to a range of numbers. We use the Spherix data because it's based on a nationwide chart audit, representative of the population across the country. And that chart audit really consistently reports that Medicare comprises about 65% of the dialysis patient population. So 35% would be non-Medicare, which includes commercial, Medicaid, and other government payers. So as you noted, you know, the prospective payment system, potential changes there would affect only the Medicare side of the population.
Yes. Thank you. Hi, Ed. Good morning. Thank you, Raab. Just to reiterate what I mentioned sort of high level earlier, we finished the second quarter with approximately $130 million in cash. We were very pleased to announce in late September that our partner, Kyowa Kirin, in Japan, received approval for hyperphosphatemia, and that, based on our amended agreement we made with them in April of last year, we received $30 million from them upon approval. So that is added to our cash resources on top of the $22.5 million we expect to draw later this month as part of our amendment with SLR Capital Partners. We also monetized part of the arrangement with Kyowa Kirin, with HealthCare Royalty Partners last year, and so we received $5 million from them.
We also last year received $40 million from our partners, so we are very well-resourced in light of these milestone payments we've received.
Thanks so much, and congrats again.
Thanks, Ed.
The next question comes from Joseph Thome from TD Cowen. Please go ahead.
Hi there, good morning. Thank you for taking my questions, and congratulations on the approval and all the hard work. Maybe just as it relates to treatment guidelines, what are maybe some of the key ones that need to be updated? And I guess, does the nephrology community follow closely these treatment guidelines? Do you anticipate that that's gonna be a major driver of uptake, if so? And then second, maybe on some of the intolerance issues that you see with binders, what's sort of the timing after initiation of binder therapy, that patients start seeing some of these tolerability issues?
I guess in your experience of monitoring prior authorizations in similar scenarios, if there are any, do you expect that they'll have to show that they're down titrating binders at all as it relates to tolerability, or is this more of a checkbox by the physician, "My patient doesn't tolerate binders," so, so they're able to go on XPHOZAH? Thank you very much.
Thanks, Joe. As it relates to guidelines being updated, there's nothing that's gonna be necessarily specific to XPHOZAH. The guidelines that are in place now, really what they do, they do is try to direct physicians to try and attempt to get their patients towards normal. The standard expectation right now is the best that you can do is 5.5, and normal is 4.5 or lower. Laura, anything to add to the guideline discussion?
No, that's absolutely correct, Mike.
Susan, if you could address the question on prior auths.
Yeah. So in terms of prior authorization, I mean, it's going to. Anyway, it's difficult to predict exactly what every major payer will put in place, but it really will be the—it's really the nephrologist that's in the driver's seat to make the decision on, based on the patient's phosphorus levels and treatment history on binders and based on their tolerability. It's a very patient, individual consideration. And, overall, with our engagement with payers to date and with our experience that we've seen with IBSRELA, it's really quite clear, the criteria of the history of being on a binder and either not being an adequate responder or not tolerating the binder. So we don't anticipate that it's going to be an, a very arduous prior authorization requirement.
However, you know, every novel drug is going to be part of a prior auth process, a branded drug, particularly when there's, you know, generically available therapies in the space. So physicians are quite accustomed to this, and what's really gonna be important is how we bring forward our comprehensive patient services program and really give the physician confidence that they're gonna make their decisions based on patients who need XPHOZAH. That's who they're gonna prescribe XPHOZAH for, and they'll work with us, and really take advantage of the programs we have in place to achieve both access and affordability, for their patients.
And Joe, the one thing we'd expect is most of these patients have been intolerant to the binders that they're on and shift between and amongst them over time. So they already have an established record of intolerance to what they've been taking. So it's gonna be attestation of that physician who says, "Mike, for example, has attempted one binder, two binders," whatever it may be, and the attestation would be that he needs XPHOZAH, and that's the way we believe it's more likely to operate, similar to what we see with IBSRELA.
Perfect. Very helpful. Thank you very much. Congrats again.
The next question comes from Matt Kaplan from Ladenburg Thalmann. Please go ahead.
Hi, good morning, guys, and let me add my congratulations. Definitely, definition of persistence and tenacity here. So a lot of questions, a lot of questions have been asked, but Susan, maybe can you help us understand kind of the evolution of payer coverage and patient access and what you expect? Obviously, that's one of the, you know, major bottlenecks in terms of uptake of a drug, and how we should think about that over the next six months.
Yes, thanks for the question, Matt. The, you know, novel therapies, very typically... Repeat the question.
...the process for the prior auth.
The process for the prior auth.
The evolution over time.
Yes. Thank you. Thank you, Matt. Thank you, Mike. Okay, there is no, like, major milestone, Matt, for you to be, like, building a timeline around. That's what people need to understand as it relates to novel therapies. This is, this is the case for novel therapies that we, as commercial leaders, have seen in many different cases. We saw this with IBSRELA as well, so we're quite confident it's what we'll see with XPHOZAH. And that is that, that these products are available, particularly in high unmet need areas with novel therapies, are available via exception, really very soon, very quickly upon launch. So it's really a matter of physicians being willing to, you know, and their office staff, to, to work with us on the prior authorization process.
If they submit the prior authorization and the patient meets the criteria for XPHOZAH, they will gain access to XPHOZAH. Those prior authorizations will be considered, and access to XPHOZAH will be granted. It's very important. We have been engaged with payers already for several months. These are the same payers we were engaged with with IBSRELA, who published good, clear coverage policies for IBSRELA within the first few months after launch. And we have been engaged with those same payers, educating them on XPHOZAH, and see it following a very similar path. So it's really gonna be a very continuous, smooth process, that really the uptake will center more on the physician motivation to for these patients who have been in such need for a novel therapy, to actually prescribe XPHOZAH and engage in that prior authorization process.
That's what's going to determine the uptake of XPHOZAH.
And, Matt, what I would add to that is that, you know, I think with what you've seen with IBSRELA is we embrace the prior authorization process, because it is clear, it is understandable, the attestation of the physician is what drives it. And the investment that we've made in this incredible team at ArdelyxAssist, including where we will have access managers in the field working with our ABDs, is it's a critical component of the success that we're gonna have. In today's world, with the complexity of payers, you need to see that as one of the opportunities, not necessarily the barriers. It's certainly something you need to walk through and hoops you need to deal with.
But when you have the right people on the team that we have put in place, we feel very confident that those are not gonna be significant barriers given the nature and the need of what these patients have.
No, that's really helpful. Thank you for the added detail.
Thanks, Matt.
The next question comes from Julian Harrison, from BTIG. Please go ahead.
Hi, good morning. Congratulations on this great news and excellent timing ahead of ASN next month. Most of my questions have already been asked, but beyond your existing partnerships in China, Japan, and Canada, are there any other ex-US economic areas you would highlight as being future opportunities for licensing? And are you able to comment on any potential timing there? And then, IBSRELA growth has been very strong as of late, so I, I guess with that in mind, is it fair to assume there shouldn't really be any reallocation of resources away from your IBSRELA franchise going forward?
Let me address the second part first. No. As I said in my comments, we are laser focused on IBSRELA. It is an incredibly important product, and again, the team that we have in place there, from the ABDs, the access support that we have, it is similar, if not identical, to what we're going to be doing for XPHOZAH. So we will not take our eyes off of what we're building with IBSRELA. It's a critically important product for those patients and certainly for Ardelyx. And, first part of your question, I'm sorry?
First part of the question was,
Oh, yes, I'm sorry. Yes.
-partnership opportunities.
Absolutely. You know, nothing that we can comment on, it's ongoing, but now that we have this label, I think it helps us then have the interactions as to what it looks like here in the United States now that Japan is approved. It will give us that much more opportunity to have discussions with potential partners in other territories. Probably no more guidance or detail beyond that.
Great. Thank you. Congrats again.
Thanks a lot.
This concludes our question and answer session. I would like to turn the conference back over to President and CEO, Mike Raab, for any closing remarks.
Thank you. Today marks a new era, a new era for patients that now have another option to help manage their hyperphosphatemia, and a new era at Ardelyx as an established commercial organization with two in-market products. It is also the conclusion of an emotional journey for every person at Ardelyx. For me, personally and professionally, this is a very, very humbling moment. As many of you know, I often refer to quotes or passages that capture a moment. I believe that this time can be well captured by a phrase said by Winston Churchill when he said, "Now, this is not the end. It is not even the beginning of the end, but it is perhaps the end of the beginning." That is certainly true for us. This approval wasn't the finish line. It is a mile marker on a longer journey.
We now embark on the next phase of Ardelyx. Thank you.