Ardelyx - Q2 2024
August 1, 2024
Transcript
Operator (participant)
Welcome to the Ardelyx Second Quarter 2024 Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note today's event is being recorded. I would now like to turn the conference over to Caitlin Lowie, Vice President of Corporate Communications and Investor Relations at Ardelyx. Please go ahead.
Caitlin Lowie (VP of Corporate Communications and Investor Relations)
Thank you. Good afternoon and welcome to our Second Quarter 2024 Financial Results Call. During this call, we will refer to the press release issued earlier today, which is 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 the risk factors in our most recent quarterly report on Form 10-Q that was filed today and can be found on our website at 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. Our President and CEO, Mike Raab, and Chief Financial and Operations Officer, Justin Renz, will share prepared remarks before we open the call to questions.
I will now hand the call over to Mike.
Mike Raab (CEO)
Thank you, Caitlin, and good afternoon, everyone. It is great to be back together to discuss another quarter's strong performance. Across all fronts, we continue to drive exceptional progress. IBSRELA's growth momentum continued at a strong pace, with another quarter of meaningful gains, with revenue growing 25% compared to the first quarter of 2024 and nearly double compared to the second quarter of last year. This performance demonstrates the important role IBSRELA is playing in addressing the large unmet need among patients with IBS-C. Every month, we continue to see increases in new and repeat writers, as well as new and refill prescriptions. Healthcare providers see their patients having positive experiences with IBSRELA and are expanding the number of patients in their practices for whom they prescribe. Our market access and affordability program, Ardelyx Assist, provides a straightforward path for patients to access IBSRELA.
Caitlin Lowie (VP of Corporate Communications and Investor Relations)
IBSRELA is an important and effective treatment option that is bringing relief to more and more patients who, despite previous treatment, continue to experience the debilitating symptoms of IBS-C. The potential for IBSRELA is significant and reinforces our conviction that it can achieve at least a 10% share of the IBS prescription market and is well on the path to becoming a billion-dollar product before patent expiry. The launch of XPHOZAH has been remarkable and makes it abundantly clear that patients have needed a different option to manage their phosphorus when binders are insufficient or not well tolerated. Nephrologists are responding favorably to the benefit XPHOZAH is providing their patients and are increasingly integrating XPHOZAH into their therapeutic regimens. The consistent feedback from the field is that healthcare practitioners are seeing serum phosphorus improvements in their patients, many for the first time as a result of XPHOZAH.
These dynamics are translating into significant growth for XPHOZAH in only the second full quarter since launch. Throughout the development and commercialization of this important therapy, we've demonstrated how vital it is for us to assume the role we have to advocate for the rights of CKD patients on dialysis. As we discussed during our call in July, we believe that moving XPHOZAH into the Medicare bundle would severely restrict and effectively eliminate access to XPHOZAH for all patients. To allow patients who are now and may in the future benefit from XPHOZAH to no longer have access to the therapy due to a misguided government payment policy is not acceptable.
We believe that CMS is not acting in the best interest of patients and has instead ignored the countless voices from patient, physician, and provider communities who have clearly and consistently communicated that oral-only phosphate-lowering therapies do not belong in the bundle. As we have announced in the past month, we have chosen to advocate for patient access to XPHOZAH across numerous fronts. First is the Kidney Patient Act. There is significant support for this bill across multiple stakeholder groups, and we call on Congress to act and pass this bipartisan, bicameral legislation and protect access to all phosphate-lowering therapies for all dialysis patients. Second, we announced in mid-July that we filed a lawsuit claiming that CMS's plan to move oral-only phosphate-lowering therapies, including XPHOZAH, into the bundle is unlawful and oversteps its statutory and regulatory authority.
In addition, the complaint argues that the plan is incompatible with CMS's own regulations stating that renal dialysis services do not include those services that are not essential for the delivery of maintenance dialysis. We seek relief under the Administrative Procedure Act to enjoin CMS from proceeding with its plan to include XPHOZAH in the bundle and thus eliminate coverage for patients under Medicare Part D beginning in January 1, 2025. We are honored to be joined in this lawsuit by the American Association of Kidney Patients, the nation's largest independent kidney patient organization, and the National Minority Quality Forum, the nation's largest minority healthcare research, education, and advocacy organization. Their partnership demonstrates just how significant of an impact this policy will have on patients and how critical it is that we protect patient choice and timely access to phosphate-lowering therapies.
We are still early in the process and cannot share details regarding our expectations of timing or success. At this point, we await confirmation that a government lawyer has been assigned to the case, and then we will be able to commence discussions regarding a timeline. We are hopeful that there can be some action before the end of the year on the case. Third, with our decision not to apply for TDAPA, we believe that we are able to continue making progress on our strategy to maximize patient access to XPHOZAH. As we learn more and make decisions, we are committed to communicating to you as comprehensively as possible. I hope that what you can take away from our past actions and from our approach is that we will exhaust all options available to us to protect patient access to XPHOZAH and to protect our business.
What should be clearer from my remarks and from Justin's to come is that our business is growing and our performance during the second quarter demonstrates the strong fundamentals driving this growth. Delivering on our priorities, executing our disruptive commercial and market access approach, and remaining committed to the Ardelyx mission of putting patients first. Our two first-in-class medicines are bringing meaningful benefits to patients. We are well capitalized, and we are focused on our future, both in terms of our current products as well as pipeline expansion. I will now turn the call to Justin, who will walk through the details of our financial performance. Justin.
Justin Renz (CFO and COO)
Thank you, Mike. I'm very pleased to be with you to discuss the second quarter performance we reported earlier today, which included significant growth for both of our commercial products and thoughtful management of our finances while maintaining a strong balance sheet. Let's start with revenue. We reported significant year-over-year revenue growth during the second quarter, totaling $73.2 million. That is compared to $22.3 million in total revenue during the same period in 2023. This growth reflects incredibly strong performances from both IBSRELA and XPHOZAH, which together totaled $72.6 million in net product sales revenue in the second quarter of 2024, compared to $18.3 million in net product sales revenue coming from IBSRELA alone in the second quarter of 2023.
Caitlin Lowie (VP of Corporate Communications and Investor Relations)
Before I jump in, I'd like to take a moment to share our perspectives on the publicly available prescription data for IBSRELA and XPHOZAH, as many of you ask how to best consider those data in relation to our revenue. First, as you know, our net sales revenue is based upon bottle shipments to our distributors and is not directly linked to prescription-level data available from Symphony or IQVIA. As we've discussed, our distributors and pharmacies keep limited amounts of product in the channel, essentially just-in-time inventory management. I encourage you to use some caution as information from prescription data providers can be incomplete and inconsistent, especially for medicines like IBSRELA and XPHOZAH as a result of our market access and distribution strategy that relies on the critical relationship between HCPs, specialty pharmacies, and Ardelyx Assist. Remember too that not all prescriptions are a 30-day supply.
Some are 60-day and some are 90-day supply. We understand the desire to use those data, but we want you to consider these dynamics moving forward. With IBSRELA, we began providing with revenue guidance when we were comfortable and we were able to provide a solid expectation of the future performance of the product. We will provide similar guidance to you for XPHOZAH when we have a solid perspective of our future expectations. For the second quarter of 2024, net product sales revenue for IBSRELA was $35.4 million, nearly doubling the $18.3 million in revenue we reported during the same period last year and 25% quarter-over-quarter growth compared to the first quarter of 2024. IBSRELA's performance was due to strong volume growth resulting from demand driven by our commercial focus on increasing both depth and breadth of writing.
That focus continues to translate into growth in new and refill prescriptions as well as expansion of new and repeat writers. We also benefited from the expected improvement in our gross-to-net deduction for IBSRELA, which decreased from 33.5% in the first quarter of this year to 29.7% in the second quarter. As we have seen over the past two years, we expect this to gradually improve over the remainder of the year. We are in the final stages of completing the expansion of the IBSRELA sales team. The IBS-C market has responded very favorably to the IBSRELA product and clinical profile and our marketing efforts. It is also clear that increasing exposure and frequency of messaging to our target healthcare providers generates new writers and expands the number of patients treated by existing writers. We expect the expanded sales team to begin having an impact later this quarter.
As we consider the second half of the year, the fundamentals driving IBSRELA's performance remain. We anticipate continued strong quarter-over-quarter growth for the remainder of this year, and we reiterate our guidance. We expect full-year 2024 IBSRELA U.S. net product sales revenue will be between $140 million-$150 million. Now turning to XPHOZAH. XPHOZAH continues its exceptional performance, reporting $37.1 million in second quarter net product sales revenue, up from $15.2 million we reported in the first quarter of the year. Growth continues to be driven by strong demand from healthcare providers who have a clear need for a new and different option for dialysis patients to help them achieve target phosphorus levels. In addition to strong demand for XPHOZAH, our gross-to-net deduction improved from 23.8% in the first quarter to 21.4% for this second quarter period.
As is the case with IBSRELA, the primary deductions reflected in our gross-to-net for XPHOZAH are the standard fees to our distributors, rebates and discounts to the government payers, and costs associated with our commercial copay program. Consistent with our distribution and market access strategy, we do not contract to provide rebates to payers or pharmacy benefit managers. Commercial patients who have an out-of-pocket copay cost may have their copay requirements covered. Thus, the impact on our gross-to-net is highly dependent on our payer mix and utilization of our commercial copay program. We are very pleased with these results to date. As we continue to learn more about the patient and payer mix that impacts the calculation, we will provide our expectations for the gross-to-net deduction as we do with IBSRELA. We are very pleased with our top-line results during the quarter.
Our commercial approach is working, and our teams are executing at the highest level to build and maintain the growth momentum we've established for both IBSRELA and XPHOZAH. Now for the expense and cash side. Throughout the second quarter, we continue to be thoughtful in how we manage our expenses. Research and development expenses were $12.8 million compared to $8.3 million during the second quarter of 2023. This increase reflected expanded field-based medical affairs teams focused on the gastroenterology and nephrology communities. Selling general and administrative expenses were $64.7 million for the second quarter compared to $27.2 million for the same period of 2023. The increase was related to commercial launch activities for XPHOZAH, investments to grow IBSRELA throughout last year, as well as the expansion of the IBSRELA sales team that I just spoke to, which occurred primarily during the second quarter of this year.
As I previously communicated, we expect our SG&A run rate, once the expansion is complete, to be approximately $80 million per quarter. Substantial top-line growth, combined with thoughtful cost management, resulted in a net loss of approximately $16.5 million or 7 cents per share compared to a net loss of $17.1 million or 8 cents per share in the same period of 2023. Our $16.5 million net loss for the second quarter of 2024 included $12.3 million in combined non-cash expenses from share-based compensation and non-cash interest expense related to the sale of future royalties. We finished the second quarter in a strong cash position. As of June 30, 2024, we had total cash, cash equivalents, and short-term investments of $186 million as compared to $184.3 million at the end of 2023. We did not engage in any fundraising activities during Q2.
However, as a reminder, we drew the $50 million Tranche C from our debt agreement with SLR Capital back in March. We are pleased with our performance during the second quarter, driving continued substantial top-line growth across our product lines, managing our operating expenses, and maintaining a strong balance sheet. We will continue to be thoughtful with how we deploy capital while focusing on maximizing shareholder value. With that, I'll hand it back to Mike.
Mike Raab (CEO)
Thanks, Justin. Q2 was a remarkable quarter. We demonstrated significant growth for both our products, and we shared our perspectives on the impact of the oral-only drugs entering the Medicare bundle and our commitment and plans to fight for patients. We are considering all options and making progress, yet we still have a lot of work to do. We do not fight alone. I would like to extend my sincere thanks to our many partners, physicians, patients, and advocates, as well as all of Team Ardelyx, who are lending their voices to the important work we have ahead of us to protect patient access to XPHOZAH. The past few weeks have demonstrated just how aligned we all are in supporting patients and making sure that they have access to innovative therapies.
Caitlin Lowie (VP of Corporate Communications and Investor Relations)
We have a team in place to deliver, and we will continue to update you as developments occur and progress is made. We appreciate your support as we move through the next few months. I will now open the call to questions. Operator.
Operator (participant)
Thank you. We will now begin the question-and-answer session. To ask a question, you may press star and one on your telephone keypad. If you're using a speakerphone, we ask that you please pick up your handset before pressing the keys. If at any time your question has been addressed and you'd like to withdraw your question, please press star and two. Today's first question comes from Louise Chen with Cantor. Please go ahead.
Louise Chen (Analyst)
Hi. Congratulations on the quarter, and thank you for taking my question. So first question I had for you was on XPHOZAH. Obviously, the sales were very strong, and you mentioned something from a gross-to-net perspective that sounded like it may create some volatility quarter to quarter. So just curious how you think we should model or think about forecasting the product going forward. And just wanted to confirm it sounded like there was not any inventory build, but just wanted to confirm that there wasn't anything like that. Thank you.
Mike Raab (CEO)
Hey, Louise, thanks for the question. Yeah, I mean, Justin will go into some detail on it, but I think really what we're trying to communicate there is, as we did with IBSRELA, giving specifics on guidance is premature at this stage for XPHOZAH as we're learning the ins and outs of what's happening. Justin, if you can provide some perspective too.
Justin Renz (CFO and COO)
Sure. Thanks, Louise. Yes, both products continue to have low amounts of inventory in the channel, so that's been very consistent throughout the course of actually both product launches. And from the gross-to-net perspective, the largest variable is in our commercial copay program, and so there's been some mild fluctuation. And of course, as Mike suggested, it is sensitive to the payer mix. So we continue to learn more and more about how that goes, but we're pleased with what we've seen so far.
Louise Chen (Analyst)
Okay. And maybe if I could just ask one more question here. I was curious with respect to XPHOZAH and your initiatives to keep it out of the CMS bundle. I know you sued CMS. What other initiatives could you take to fulfill what you're trying to do? Thank you.
Mike Raab (CEO)
Well, I think that's the work that we're doing is still ongoing, so it's premature to go into any of that. There's a lot of work going on behind the scenes. I think, as you've seen, Louise, we will exhaust all options to make sure that patients continue to have access to these drugs.
Louise Chen (Analyst)
Okay. Thanks.
Operator (participant)
Thank you. Our next question today comes from Yigal from Citi. Please go ahead.
Yigal Nochomovitz (Analyst)
Yeah. Hi. Thank you very much. Just as we could follow on the inventory question, is it possible that you could provide any quantification of what the low inventory looks like for both products? And then on the SG&A, you mentioned, Justin, I think, $80 million run rate per quarter. Just, can you comment on when you would get to that point? Thanks.
Mike Raab (CEO)
Yeah, Justin.
Justin Renz (CFO and COO)
Sure. So on the latter, so SG&A was $64.7 million in the second quarter, which, of course, includes non-cash stock compensation expense, and we continue to add to the sales force. So we expect to get, as we build the sales force and we're almost done with the ramp-up of the IBSRELA sales team, we should hit that $80 million level in the fourth quarter of this year. In terms of inventory in the channel, both products have been very consistently low. We have a very tight distribution channel, and so there's obviously some variability on a specialty pharmacy to specialty pharmacy basis, but in general, we've been in that 1.5-2.5 weeks maximum and closer to 2 weeks tops in the channel on a regular basis.
Yigal Nochomovitz (Analyst)
Okay. Thank you very much.
Operator (participant)
Thank you. Our next question today comes from Dennis Ding with Jefferies. Please go ahead.
Dennis Ding (Analyst)
Hi. Thanks for taking our questions and congrats on a really strong second quarter. So I had a question on IBSRELA. You guys have been obviously expanding your sales force since earlier this year. Just wondering how much of second quarter's performance stems from some of these new sales reps, and you'll be expecting an inflection in the second half as you complete some of these new hires. And maybe you can comment on when you expect those new hires to be hired. And then as a follow-up, just on R&D, I mean, we appreciate you guys have two very successful commercial franchises, but one piece of feedback we get from investors since the tenapanor patents do expire in early 2030 is how are you guys thinking about the pipeline? So where is this on your list of priorities, and how soon can we hear more about that? Thank you.
Mike Raab (CEO)
Hey, Dennis, thank you for the question. In terms of sales force expansion, I think with Justin's comments, you heard that we expect that the full expansion will begin having impact by the end of this month. It's a process to hire 60 new people. They don't all come on at once. You need to train and certify. So the full team is not on board until the end of this quarter, so we expect that. And as we said, we're reiterating our $140-$150. Dennis, you know us well by now that we're not going to get over our skis. We're thrilled with the performance, but I think what you can count on is the reiteration of the guidance that we've given.
Caitlin Lowie (VP of Corporate Communications and Investor Relations)
In terms of R&D, I think as we've discussed before, one of the reasons that we've had brought Mike Kelleher on board as our Executive Vice President of Strategy and Corporate Development was to address exactly the question that you have brought up, is looking for those programs that we could bring in-house that are complementary to what we have created with both XPHOZAH and IBSRELA. As we make progress on those things, certainly that's what we will bring to the fore and share with everyone.
Dennis Ding (Analyst)
Great. Thank you.
Mike Raab (CEO)
Thanks, Dennis.
Operator (participant)
Thank you. And our next question comes from Laura Chico with Wedbush. Please go ahead.
Laura Chico (Analyst)
Good afternoon. Thanks very much for taking the question. I guess just two here. One on IBSRELA. Congrats on the progress. I'm wondering, could you talk a little bit about what's necessary to see pull forward in the earlier lines of utilization? And with respect to your prior peak estimates here, can you remind me how much does earlier utilization play into your assumptions? And then I think I missed it, but XPHOZAH, what was the split on Medicare versus non-Medicare? Thank you.
Mike Raab (CEO)
Yeah. So to the latter question first, we didn't provide that split. I think implied in Justin's comments about gross-to-net, those are things that we're going to see evolving over time. So I think we talked historically about a 45-55 split, non-Medicare to Medicare as an example. In terms of IBSRELA, the specificity is to, I think what you're asking about previous utilization pulling forward is refill prescriptions and rate of that. We've not talked about that, and I think still it's something that we're looking to understand and not sharing at this stage. But it's both, right? It's new patients as well as refills. It's physicians that our incredible team on the ground has convinced to try, and then that they are expanding their utilization across the broader patient population.
Caitlin Lowie (VP of Corporate Communications and Investor Relations)
It's the grit and the grind that this team does, and that was what drove much of the decision around the expansion that we expect to see the impact of by the end of this month.
Laura Chico (Analyst)
Thanks very much, guys.
Mike Raab (CEO)
Thanks, Laura.
Operator (participant)
Our next question today comes from Roanna Ruiz with Leerink Partners. Please go ahead.
Roanna Ruiz (Analyst)
Hi. Afternoon, everyone. Question on XPHOZAH. I was curious what current field force strategies are getting the most traction so far with physicians in the first couple of quarters of this year. And if you can elaborate, is volume coming more from possibly new or repeat prescribers so far, and how that affects their conviction going into the second half of this year with XPHOZAH?
Mike Raab (CEO)
Hi, Roanna. Thanks for the question. So we're two quarters in, so it's kind of tough to think about repeat writers yet. I think is probably not inconsistent with other launches. Physicians are going to be trying drugs on their hardest to treat patients. And the fact that you then see expansion within that physician to other patients says that it's working in those patients. And those patients who may be less challenging or having less of a difficult time managing their serum phosphorus deserve the opportunity to have a product like XPHOZAH helping them manage their phosphorus levels. So it's across the board, and that's the enthusiasm that we have. Anecdotally, we hear these stories about patients who, for the first time ever, are able to get their serum phosphorus in control. That's meaningful, right?
Caitlin Lowie (VP of Corporate Communications and Investor Relations)
When you've only had binders your entire career through your training as a nephrologist, and then you have a new mechanism like XPHOZAH as an opportunity to help your patients get to goal, you're going to try it. And if it works, as this does, you're going to expand its use.
Roanna Ruiz (Analyst)
Got it. Makes sense.
Operator (participant)
Thank you. Our next question today comes from Ryan Deschner with Raymond James. Please go ahead.
Ryan Deschner (Analyst)
Hi there. First off, congratulations on the impressive quarter. Two quick questions for me. At this point, are you getting any feedback from prescribers suggesting there's uptake in patients with adequately controlled serum phosphorus? And number two, regarding your litigation with CMS, what would the timeline for securing access to XPHOZAH for Medicare patients look like in sort of the best-case scenario here? Thanks.
Mike Raab (CEO)
Hey, Ryan. Thanks for the question. It's an interesting question because you would think that patients in control deserve the opportunity for something like XPHOZAH too. I can say that not many stories yet that are coming that way, as I think the enthusiasm and excitement that we see is don't forget that almost 80% of these patients over time, in the six-month period of time, are out of control. So one might say in control today, but historically not, they deserve the opportunity as well.
Caitlin Lowie (VP of Corporate Communications and Investor Relations)
So, I think it's all over different kinds of profiles. So, the most important thing is what we're hearing is very strong results in terms of patients getting to goal. I think from the comments that we made, it's premature for us to be providing any commentary in terms of where the status of the lawsuit stands. We are committed, as we learn more in terms of the timeline of discussions that we will have with government lawyers, that we will share that.
Ryan Deschner (Analyst)
Thank you very much.
Mike Raab (CEO)
Thanks, Ryan.
Operator (participant)
Our next question today comes from Joseph Thome with TD Cowen. Please go ahead.
Joseph Thome (Analyst)
Hi there. Good morning, and thank you for taking my questions. Congrats on the quarter. Maybe just to, for me, to follow on a little bit on a prior question, can you talk a little bit about the breadth of prescribers that you're seeing for XPHOZAH versus maybe your overall target prescriber account base? And then second, just to get a little bit of understanding, I guess if the bundle does go through and we don't really hear by the end of the year that that will be extended, I guess what sort of happens to Medicare patients that are currently on XPHOZAH? Is there a grace period, or does that hit January 1st and we have to figure out how to get medicine to patients or not? Thank you.
Mike Raab (CEO)
Sure. Thanks for the question, Joe. So in terms of the breadth of prescribing, again, we're two quarters into this launch, and we've got an incredible field force of 60 ABDs making those calls. What I can say is the interest on the part of all those physicians that we have been able to see clearly is demonstrated by the revenue that we announced today. So I think we continue on the path that shows that these patients truly deserve the access that we're fighting for for them. To your question about Medicare, if things move forward, we have an important continuity of care program that exists for patients. So that is going to be something that, if we need to, patients are going to be able to access.
Caitlin Lowie (VP of Corporate Communications and Investor Relations)
Our hope is, honestly, with everything that we're doing and our continued evaluation of other things that we might do, is that we don't come to a place where patients who deserve access to a drug like this are prevented to do so because of a misunderstanding or unlawful perspective that CMS has about what we're trying to fight against because they're just going to ultimately effectively ensure that patients don't get this drug that's working if they continue on the path that they're on.
Joseph Thome (Analyst)
Perfect. Thank you.
Mike Raab (CEO)
Thanks, Joe.
Operator (participant)
Our next question today comes from Ed Arce with HC Wainwright. Please go ahead.
Ed Arce (Analyst)
Hi. Thanks for taking my questions. Let me add my congrats on a truly remarkable quarter of growth here. First question is on XPHOZAH. 145% quarterly growth sequential and already surpassing IBSRELA in the second full quarter. I wanted to ask about what's driving that. Obviously, you've mentioned inherent strong demand and the focus on difficult-to-treat patients, but I wanted to ask if there's other areas that you've discussed with physicians that could share a little bit more light on this, and if there has been any discussion of where XPHOZAH may not be appropriate for any of their patients. Then I have a couple of follow-ups.
Mike Raab (CEO)
Sure. So remember that we started educating the nephrology community about this new mechanism and the opportunity to XPHOZAH as disease awareness before what was supposed to be the approval in 2021. We had the terrible surprise that was given to us by the FDA and resulted in the CRL. So there was a lot of disease awareness, product awareness before that occurred, and hence the fight that we started that everyone's aware of through the FDA process 2+ years later with this launch. So disease awareness, XPHOZAH awareness was significant. That certainly plays a role, Ed. But most importantly is the clear unmet need, the requirements that have to be there for patients to get to goal, and the fact that this drug is helping accomplish just that. That's a big and massive part of what is the established sort of market for the opportunity.
Caitlin Lowie (VP of Corporate Communications and Investor Relations)
But it's also the field force. We have a group of remarkable ABDs and XPHOZAH side, as we do with IBSRELA, who are doing the work required to help physicians understand an option for both of these indications where there hasn't been another mechanism with a kind of clinical benefit that both of these drugs are providing. And I think that's what's driving and is driving, as it should, what you're seeing in this quarter's performance. In terms of places where you wouldn't use it, there really aren't any comments that we're hearing from that. Remember, our label is for those patients where there is an insufficient response or intolerability to binders, which with this statistic, as we all know, insufficient is a very large majority of these patients over any six-month period of time or less, they are patients who can access this product.
I think our label, clinical benefit, the evidence that physicians are seeing in their own practices, as well as the commercial approach that we're taking, I think is resulting in what you see.
Ed Arce (Analyst)
Great. Are you aware of any physicians experimenting with this drug as a monotherapy?
Mike Raab (CEO)
Well, remember that the label says insufficient or inadequate, and how they then use that, whether it is on top of a fixed dose of binder, whether it is a decrease in binder dose with XPHOZAH on top of that, or an elimination of binder because it's not working, and XPHOZAH as monotherapy is all within the indication on our label, and all of those are approaches that physicians are taking.
Ed Arce (Analyst)
Okay. Last question is just wondering if you could explain a little bit further some of your contingency plans if it comes to pass that your efforts with CMS on the oral phosphate agents are unsuccessful and they're moved into the bundle?
Mike Raab (CEO)
Yeah. I appreciate the question, absolutely, and would love to be able to be in a position to provide you clarity on that. It's just not. It's premature at this stage. It's the work that's ongoing. I think the progress that we've made, I feel very, very good about. But you know us well by now that we're not going to get over our skis and communicate something that we aren't fully 100% comfortable with. So we believe that there are opportunities, God forbid, that what you just described occurs, but it's premature for us to provide you those details.
Ed Arce (Analyst)
Got it. Very helpful. Thank you.
Mike Raab (CEO)
Thanks, Ed.
Operator (participant)
Thank you. Our next question today comes from Matt Kaplan at Ladenburg Thalmann. Please go ahead.
Matt Kaplan (Analyst)
Hey, guys. Thanks for taking the questions. Congrats on the very strong quarterly results. Just a follow-up to Ed's question a little bit in terms of XPHOZAH. Maybe it's with the understanding it's early on the launch, but help us understand in terms of the breakdown of patients on the drug. Is it mostly being used in the combination setting? Or to Ed's question, monotherapy in patients who are intolerant of the binders?
Mike Raab (CEO)
So specific breakdown across those patients, right? You only get anecdotes, right? When a prescription is filled for XPHOZAH, it doesn't say on top of binder, on top of half binder of monotherapy. You just got a prescription for XPHOZAH. So all I can provide, all I can say is anecdotally, it's a distribution of all those patients. What that then results in, what it looks like for all the patients, I can't tell you that.
Matt Kaplan (Analyst)
Okay. Fair enough. And then any update that you're hearing as we spoke recently, but in terms of the status of the Kidney Care Act and where that is?
Mike Raab (CEO)
Yeah. I mean, we continue to make incredible progress. You saw, if you follow it as we do, two of the co-sponsors have joined on the House side. And the fact that we have, as I said in my opening comments, both bipartisan, bicameral support with the Senate companion bill is incredibly strong for us. And it's going to ultimately come down to how bills are passed, which we all know end up being in omnibus or minibuses at the end of the year, whether or not there's healthcare legislation that it can ride on, all of those things that we talked about in the past. What is clear is all of the constituents that have worked on this and continue to work on it are demonstrating why this is absolutely the right thing for Congress to do.
Caitlin Lowie (VP of Corporate Communications and Investor Relations)
While in parallel, we continue all of the other approaches from both the legal side as well as the evaluations that we're undertaking to look at what else we can do after the decision that we made to not file for TDAPA. So I think as you heard me describe in our last discussion on this in July, it's kind of like a three-dimensional chess game where we're looking at moving all these pieces and trying to make sure that we are doing all possible to ensure access for patients.
Matt Kaplan (Analyst)
Okay. Next slide.
Mike Raab (CEO)
Thanks, Matt.
Operator (participant)
Thank you. This concludes our question and answer session. I would now like to turn the conference back over to President and CEO Mike Raab for any closing remarks.
Mike Raab (CEO)
Thank you, everyone, for joining us this evening. As I'm sure you understand, we will remain focused on our priorities, and we will provide information and updates when we can. In the meantime, we remain steadfast in our commitment to patients and to maintaining our commercial momentum. With that, we can close the call. Operator.
Operator (participant)
Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful evening.