Ardelyx, Inc. (ARDX) Earnings Call Transcript & Summary

[ Hello and welcome to the Ardelyx Corporate Update Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Caitlin Lowie. Please go ahead, ma'am. ]

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 Investors 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 for the question-and-answer period. With that, let me pass the call over to Mike.

Thank you, Caitlin, and good morning, everyone, and thank you for joining today's call. This is a very big and remarkable moment for Ardelyx but especially for CKD patients on dialysis for hyperphosphatemia. At approximately 5:00 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 Frechet, 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 giving the community an advanced hyperphosphatemia. With a 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 marked 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 or 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, health care 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's been involved over the past decade, I send 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 had 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 [indiscernible]. 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 have overseen the development of XPHOZAH for the past 13 years. I was involved in discovering the molecules in our lab to developing it into a drug and testing it in an extensive nonclinical 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 GelTex Pharmaceuticals. That's where I met Mike. When presented with the opportunity to work with Mike on a minimally absorbed small molecule in the treatment of hyperphosphatemia, I'm jumped at the opportunity. I knew based on first-hand 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. And 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 biotherapy. XPHOZAH has a unique mechanism of action as the first and only phosphate absorption inhibitor, RPAI, that blocks paracellular phosphate absorption via local inhibition of the sodium hydrogen exchanger 3. I emphasize the 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 of mechanisms, which hasn't been sufficient to achieve guideline established target levels for the majority of the patients. In fact, patient chart audit data demonstrates that in a 6-month period, 77% of binded-treated patients are unable to consistently maintain serum phosphorus levels 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 nonclinical studies, greater than 20 clinical trials and a comprehensive data package involving a diverse population of more than 1,000 patients in 3 Phase III clinical trials, demonstrating the efficacy and safety of XPHOZAH. All 3 of these Phase III trials and 6 additional clinical trials have been published in peer-reviewed journals. Two of the trials block and Freedom evaluate [ explosion ] monotherapy and one trial AMPLIFY, evaluated the effect of a dual mechanism approach utilizing the novel blocking mechanism of XPHOZAH together with phosphate binding, 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 [ both ], respectively. In the AMPLIFY study, which evaluates patients who remained on phosphate [indiscernible] during the study and who are uncontrolled with the 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 and up to 49.1% of patients in the XPHOZAH plus binder arm achieved a serum phosphorus of less than 5.5 mgs per deciliter, which was statistically significant as compared with up to 23.5% in the placebo plus binder arm with p-values less than orc equal to 0.0097. As noted in the label, the only adverse reaction [ which was ] reported in at least 5% posted patients treated with XPHOZAH in our Phase III trial with diarrhea. -- with an incidence that ranged between 43% to 53% of the patients. The majority of the diarrhea events we exposed to treated patients were reported to be mild to moderate in severity and resolved over time or with dose [ pool ] reductions. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported 5% of XPHOZAH treated patients in disease 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 [ sites ] or who are intolerant of any dose of phosphate [indiscernible] therapy. XPHOZAH will be available in 30 mg tablets with patients able to titrate down to 20 mg tablet. This label will give the nephrologist community access to greater flexibility in how they can treat their patients. XPHOZAH addresses the critical need among this patient population with -- for another option to help patients reduce their [ serum phosphorus ]. In addition to our Phase III trial, we conducted an open-label trial optimized to help nephrologists integrate XPHOZAH into their clinical practice. In optimized, patients on a phosphate binder with uncontrolled serum phosphorus defined as greater than 5.5 mg per deciliter had XPHOZAH added 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 pool respectively, were able to achieve target serum phosphorus goals. Overall, 84% of patients who reported an improvement in their phosphate management food routine. During the past 10 years, I've traveled to numerous dialysis centers around the country and have the opportunity to speak with many patients and their care team, 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 actions and its comprehensive data package to nephrologists and enhance 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 plans, 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 the 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 agent 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 near 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 treatment for hyperphosphatemia, 3/4 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 6 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 therapy. 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 3 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 level. 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 3 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 do not tolerate any dose of binder therapy. Key launch initiatives align with these core foundational elements. We have built a nephrology sales force [ size as 60 ] dedicated to cover the approximately 8,000 nephrology health care providers who write the majority of the hyperphosphatemia prescriptions. The 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. 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 the 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 with business 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 evolve 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 has the opportunity to be treated with a new therapy. There is high awareness and anticipation to adopt XPHOZAH. It is poised for rapid market update 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 timeframe. Our strategies and capabilities disrupt market and advanced 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 one agreement with SLR Capital Partners or Solar. The loan agreement amendment provides Ardelyx with access to up to $100 million 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 reflected on the first tranche of capital that was drawn back in February 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 15, 2024. And in addition, we can elect to borrow an additional fourth tranche of up to $50 million subject to Solar credit approval. The interest-only period for any drawn funds associated with the facility has been extended to December 31, 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 Solar's pricing of 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 investments. 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 does not limit patients who prescribe XPHOZAH from getting their treatment. We will enter 2024 commercializing 2 products and investing in the future of our debt. 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 Solar agreement. We look forward to sharing our third quarter results in 2 weeks. The approval of XPHOZAH and the commercial success of IBSRELA and our current cash balance places Ardelyx in a position of strength to [indiscernible] 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 that 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?

[Operator Instructions] Our first question comes from Chris Raymond from Piper Sandler.

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 of 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 on the prior auth process. So with the labeling language around inadequate response and intolerance, there seems to be some sort of, I would argue, gray area in terms of defining both. You guys mentioned a lot of the data. I think this is from Spherix with 1/3 of patients at any point in time or at that snapshot being inadequate responders, but over 70% of patients over the last 6 months, being inadequate responders, how do you think payers will define sort of that part of the label in terms of being inadequate responders or for that matter, intolerant of treatment? One would argue with that pill burden everyone's intolerant. So how do you anticipate the interpretation of that?

Sure. Chris, thanks for the comments, too. It has been a remarkable year in for all of us, and we're really excited about getting XPHOZAH out to patients. As it relates to price, we wanted to wait and see the final language in the label to dot the i's and the t's. Our expectation is when we talked about earnings on the 31st, that's when we would tell everyone what the prices that we are going to come to. So no magic around it. We just want to make sure we do all the work that we need to do. I am going to ask Susan to address your questions on prior authorization. But I think really, you hit the nail on the head, plus 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 intolerant and insufficient but the process that Susan and the team have put in place to facilitate going through I'll ask Susan to address.

Yes. Chris. No, Mike is exactly right. 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 persist and not being able to maintain those target levels. So -- and really recognize the value of a novel mechanism drug like XPHOZAH. And now with the indication being indicated for that group of patients, binder treated patients who have an inadequate response or intolerant, 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 by a prior authorization. And as you know, patients' phosphorus levels 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 the physician call, as Mike mentioned. 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 therapy. So we see that as actually 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 sampling as part of 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?

Yes. So obviously, it's a core component to our overall promotional presence in the space. We will be focused on the nephrology call point in nephrology offices. And obviously, we'll have samples available. We're not going to give specifics on the overall volume. It's just 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 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.

The next question comes from Louise Chen from Cantor.

Congratulations on all the great news and progress here, and I had a couple of questions for you. So I wanted to ask you, how much inventory have you built for the launch? And do you think this will be 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 this going to be a launch event for you? Or what are you thinking there? And then last question is just congratulations on this debt financing. How does that add to your current cash runway?

Thanks, Louise. Let me have Justin address the first and the last first and then we'll have Susan talk about ASN. But 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, and we are working as a team now to get inventory in the channel to be available for the nephrology community as soon as possible. But we're in great shape for the rest of this year and well into 2024. Regarding the cash balance, 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. And between June 30 and today, we also received approximately $35 million from our partners at Kyowa Kirin and Healthcare Royalty Partners as well as $2 million from a milestone we achieved from our partners in China. So we are well resourced in a great cash position right now, and we'll give you, obviously, more specifics on October 31.

And 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 commercial launch branding, all will be present there 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 a spotlight series. So we'll have our opinion leaders presenting on the clinical data for XPHOZAH and the importance and the high unmet need in this space 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.

The next question comes from Dennis Ding from Jefferies.

Congratulations on the approval. Two questions for me. So as you guys are launching XPHOZAH and 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 given some of the prior comps in hyperphosphatemia space. I think Auryxia and Velphoro. And then number two, there's been a lot of industry news and developments around GLP-1. And [indiscernible] obviously had some positive development in CKD. What is your messaging to investors on GLP-1 and the impact to the dialysis market specifically hyperphosphatemia?

Dennis, thank you. As it relates to launch curve, I think we should all be thinking about the information that Susan shared is to the pent-up demand, both from our market research and from Spherix. 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 had resulted in what everyone has seen with IBSRELA performance. There's no reason to believe that XPHOZAH is going to be any different in 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 as we did with IBSRELA. We wanted to wait 5-plus quarters before we were firm in giving guidance and specifics like that. So we'll probably follow a similar pattern of this just because we want to make sure that we're giving you real actionable and important information. De 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?

Yes. 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 '20 -- in 2000 and remain 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 from 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.

The next question comes from Yigal from Citigroup.

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, 2 of the 3 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 good candidates for monotherapy?

Sure. Thanks, Yigal. You just hit the nail on the head. We feel that this indication is right on 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.

Yes. 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 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. And that will be a patient that obviously would be eligible to use XPHOZAH. And so I think there are a myriad numbers of ways that we would see this that actually align with the label. Our optimized 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 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. 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 U.S. 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 U.S. market. And then obviously, now that you have 2 commercially approved drugs, and you're generating -- going to generate more cash. Do you have any early thoughts on timelines to profitability.

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 2 products on the market, Justin, why don't you...

Yes. Thank you for asking, Yigal. Unfortunately, we're not at a point where really, we can share what the breakeven point is. And as I mentioned earlier, we're very well resourced at this time and we're very excited about the opportunity now that XPHOZAH is going to be made available by 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 our recent financing we just announced. But unfortunately, 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 2 weeks.

The next question comes from Laura Chico from Wedbush Securities.

So I guess, first, following up on the question just regarding phosphate binder launch curve. I guess just to be clear here, is 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. Those are 2 of the incredibly important components of what makes this different. But let me ask Susan to address it in more detail.