Good afternoon, everyone. My name is Ben Davis. I'm an associate with the J.P. Morgan Healthcare Investment Banking team out of New York, and it's my privilege to introduce Ardelyx. Today, Mike Raab, the President and CEO, is going to be running through the presentation, and that will be followed by Q&A with Justin Renz, the CFO and COO, and Eric Foster, the Chief Commercial Officer.
Good afternoon, and thank you, everyone, for joining us today. I really want to thank J.P. Morgan for the invitation, and I also want to thank Team Ardelyx, who I know a number of you are listening online, and we wouldn't be here were it not for the work that you all do in helping us get our important medicines to these patients who so desperately need the benefit of the work that we have done. You know, obviously, I will be making forward-looking statements. You can refer to our 10-Q for more details. I'm extremely excited to be here today. You know, we, as you saw in our press release, released $319 million of combined revenue between XPHOZAH and Ibsrela.
You know, for a company with what we've gone through in developing these drugs, actually south of here in Fremont, California, taking them all the way through development and now commercialization is a pretty remarkable, unique opportunity for a company to have actually accomplished. You know, we are here to build an important company. We had $158 million of sales for IBSRELA. That's 90%, almost 100% growth year- over- year. With XPHOZAH, it was our first year of launch, and that's $161 million of revenue that we generated last year with just remarkable growth in that product. We have an extremely strong financial foundation with $250 million on the balance sheet, and we're in the process of beginning business development opportunities as we begin to look to build a pipeline and build a sustainable enterprise.
That is our objective, and maintaining the commercial momentum that we have created for the company. Let me talk a little bit about IBSRELA and, you know, what this product has generated in terms of the benefit for patients who have so desperately needed it. You look at the growth of the IBS-C marketplace. In 2024, we saw an 11% growth of total Rxs for IBS-C patients. I think that demonstrates the amount of unmet need that there is out there for people with IBS-C. And historically, there has been one mechanism of action to treat those patients, and yet with that incredible advancement that's been made for IBS-C, almost 80% of those patients are unsatisfied with the therapies that are there.
That was the opportunity that we saw with the development of IBSRELA, was to begin to find a way to meet that unmet need that those patients who are currently on therapies are currently experiencing. We're a new class of therapy, right? So it's a different mechanism of action compared to GCC agonism. And what it does, it works to inhibit NHE3, providing more fluid in the GI, pain benefit, and bloating benefit that these patients suffer every single day. We provide, with this mechanism and the data and the experiences, more importantly, that our patients have very quick, lasting relief for their symptoms from which they suffer. And it's something we, as a company, do not take for granted, the benefit that we provide them, given the disruption that IBS-C causes in their lives.
The initiatives that we have to continue these efforts is we just finished the expansion in the Q3 last year of our incredible sales team from 64 people to 124 throughout the United States. And we saw in the Q4 , with that fully deployed team, the impact that they're having. We saw a greater than 30% growth in the Q4 over what we saw in performance in the third, which by any measure is clearly spectacular. Working with that team allows us to move into a broader group of healthcare providers who are taking care of IBS-C patients. Our initial strategy was to look at calling on high-prescribing GIs. And with this expansion, we've moved into APPs, so NPs, PAs, who are there to, in this particular indication, are critically important to the management and care of the patients of IBS-C.
And then high-riding non-GIs who act as though they are GIs with the number of patients that they have, and that allowed us to look and target 14,000 healthcare practitioners that are taking care of IBS-C patients. You know, we're working now as we develop tools to specifically go to the patient to help them understand when they don't have sufficient benefit from what they're experiencing, to ask their physicians, is there something new, something different that could help their symptomatology? And we'll continue investing, which is a critical component of what we do at Ardelyx, is our patient services group, Ardelyx Assist, where what is so critical about that, and I think often underlooked, is our sales organization, our ABDs, drive the top of the funnel of demand.
And pulling those prescriptions through that, and then ultimately ensuring that they are fulfilled for the patient is something you take for granted, but it's a critically important thing in today's world, particularly with a drug like IBSRELA, where we do go through a prior authorization. We're not a first-line therapy intentionally because the strategy was to take advantage of this incredible mechanism and help those patients that are not well served with the current therapies. So from that enthusiasm that we see, the benefit that we saw in the revenue in last year, we reaffirmed our guidance that we see this easily being a $100 billion product or more before patent expiry. So that's an exciting thing for us, and that's only a 10% penetration in that market that I showed early on of over 6.3 million prescriptions.
Penetrating 10% of that market with the benefit that we demonstrate is certainly achievable. So this is what we look at, right? $240 million-$250 million was also the guidance that we provided for IBSRELA in this year, and that's 52% annual growth over 2024. So again, you look at where we were with $158 million going to $250 million, we're on a trajectory that you can clearly see that it achieves that billion-dollar opportunity in revenue for Ardelyx and our shareholders. So now let me pivot to XPHOZAH. So XPHOZAH is an important, it's all the same molecules, tenapanor, and this is the first innovation for dialysis patients in managing hyperphosphatemia for over 50 years that the dialysis system has been in place here in the United States.
We've had only binders to treat patients, and this phosphate absorption inhibitor is a fundamentally important change in the way the treatment paradigm is for patients on dialysis, where instead of taking handfuls of pills, you're able to take two small pills a day and block the absorption of phosphorus at the primary pathway, which is the pericellular space, which has never been targeted before, so having this new innovative therapy is so critical for the treatment of these patients on dialysis, where before they've never been able to get to goal, and we have not only anecdotes, but building data of patients for the very first time in their lives on dialysis are able to get their serum phosphorus to target. As you can see in this slide, you know, the number of patients on dialysis that need phosphate management is significant.
And the horror of this is we lose 20% of those patients per annum due to mortality, and it's still growing at 6%. Phosphorus is one of the things that is so difficult to manage for these patients, and why we're so proud of the innovation of what XPHOZAH has brought to them, that they're able to get to target for the first time. Why does that matter? This is an independent predictor of morbidity and mortality in those patients. If you get these patients to a better serum phosphorus level, you know, the objective would be thus to lower that relative risk of morbidity and mortality in these patients, and that's the objective that we have. XPHOZAH is demonstrating in this first year the ability for patients even to be able to eat better.
We have patients that anecdotally are now able to get transplants that previously were unable to. So there's something important that's happening with XPHOZAH, and that's why we have such enthusiasm about where we are. What's really important to understand is we've all talked about over the year the challenges, the turmoil that's caused by the bundled payment system. What I really want everyone to do going forward is that has happened, and what we focus on is the patients that are available, not within the Medicare system, so it's the non-Medicare patients. It's about 220,000 patients. As you focus on that, those 220,000 patients, as we came out in our guidance, is going to generate up to $750 million.
That is an incredibly important number for you to focus on because I think a lot of people have not understood what the opportunity is, even if things moved into the bundle. So our guidance of $750 million is within the bundle, and it's looking at those patients that have coverage of 20%, excuse me, 40% of that 550,000. It's that straightforward. If we're able to have success in other areas, we will certainly share that with you, but it's important that you understand as well as that we are going to continue to provide access. This is a reimbursement issue, not an access issue. We will provide in a patient assistance program for those Medicare patients that no longer have coverage for oral medications outside of Medicare Part B, that we will provide them access to XPHOZAH through our patient assistance program if they qualify.
So for us, that's kind of a moral obligation that we have with the benefit that we've seen, and the business as we've structured it and the approach that we take allows us to do so. So as I said, you know, we did $158 million for IBSRELA, $161 million for XPHOZAH, $319 million last year. We've guided to $240 million-$250 million for IBSRELA. We've not yet given guidance for XPHOZAH for 2025, just given the turmoil that we're going through as we move into the new payer environment. And what's incredible, I think you need to also focus on is we ended the year with $250 million on the balance sheet. Incredibly strong financial position for where we're ultimately going to build this enterprise with a focused effort in business development, looking to leverage and strengthen the commercial prowess that we've demonstrated with both of these products.
Our strategic priorities should become clear as we will continue to work on sustaining and growing the growth momentum that you see with IBSRELA. It's a remarkable product, and the patients deserve access to this with the benefit we know it provides. We're going to execute on our XPHOZAH strategy. It's certainly a different approach that people are accustomed to because we will maintain access for all patients. We will focus as well on the revenue-generating patients with 40% of the total population. It's a bit different than what most people are accustomed to, but from there we derive at least the $750 million of revenue that I described. We're going to build a pipeline and work towards building a sustainable enterprise.
We've got a team on board who've had numerous meetings here at J.P. Morgan to begin those efforts to look at what would fit within the approach that we take commercially. And driving strong financial and commercial performance is at the root of what we do and what we're doing with our obligation to our shareholders. We're building a great company. We certainly believe that. We have, you know, gone through now almost 17 years of work to get to where we are today, and the future looks extraordinarily bright for us. We are excited of what we're building, what we've demonstrated that we can accomplish, and really what the future has to hold for this company. So with that, what I'd like to do is open it up to any questions that you might have on anything that I presented or about the company.
So there will be a mic coming around, so if any questions, feel free to raise your hands, but I could get things started.
In the Q4 , Ibsrela grew 30% compared to the Q4 . What was driving this growth?
So what I'd like to do is ask Eric Foster, our Chief Commercial Officer. Eric joined us in August, and I think some of the initiatives that he's put in place and the expansion is a big part of it, but I think it's really important as you hear what Eric is talking about, what we're going to be using to continue to build the momentum for the company. Eric?
Yeah, thanks for the question. Great to be with everybody here. Fourth quarter was a great quarter, more than 30% growth, quarter over quarter from Q3.
We completed our sales force expansion at the end of Q3, and they were trained and in the field for all of Q4. So we certainly saw an inflection point there. We're excited about the exit trajectory coming into 2025. It's not just about driving the top of the funnel, but you also have to pull those patients through. We've got a great hub and patient services program with Ardelyx Assist, and it performed phenomenally in the fourth quarter. So driving patients at the top of the funnel, pulling those patients through to the bottom of the funnel so more patients can have access to IBSRELA.
You provided IBSRELA guidance for 2025 of $240 million-$250 million and reiterated the peak sales of $1 billion. What do you see as some of the next steps required to reach those numbers?
Well, certainly execution, as Eric just described, right?
I mean, if you look at our growth year over year, which I think is an important way to look at it, quarter over quarter you're going to see some different changes, right? So historically, if you look at the IBS-C market, it contracts in Q1. So if you look at year- over- year, yet that grew 10% last year alone even with that contraction. So I think it's the execution that Eric described, and it's really continuing to be aware of where there might be need to focus more. I think what Eric has also worked on, if you can speak a little bit to the field access managers, pulling through people is going to be so critical. What we don't want, if I was a salesperson out in the field, I would want to ensure that that prescription was getting filled.
So, but it's probably best for the sales force to focus on the top of the funnel. So what can we invest in to ensure that everyone is pulled through and getting the drug that the physician has prescribed for them?
Yeah, so, you know, the sales force is focused on driving clinical conviction and patient identification. So in 2025, we're expanding our field access manager team. So this is a field-based team, part of Ardelyx Assist that's really focused on the pull-through. So when you think about the drivers that we have moving forward, not only do we have an increased number of sales reps, and that's important because we've been able to expand the reach and the total number of targets that we're focused on.
So not only are we focused on high prescribing GIs, but we've been able to expand the number of APPs, Advanced Practice Providers, Nurse Practitioners, and PAs, as well as expand the number of high prescribing non-GIs that the sales team can focus on. And that's really where we saw that growth in terms of new prescribers in Q4. But expanding the field team that's going to be able to focus on pulling through those patients is equally as critical as driving at the top of the funnel. So this team will work with physicians' offices on pulling through the prior authorizations and making sure that the patients can have access to the product.
And, I think.
Go ahead.
You know already my question. What are you doing or you are thinking about Europe for both products?
So, Massimo, that's a great question. We've talked about it many times, as you know.
And the same question. You know, and it's this is a medicine that people all over the world, frankly, deserve. We understand that. And I think, you know, we now have, frankly, the luxury of being able to spend the time and the focus. We have Mike Heller, who has joined us in our corporate strategy and corporate development, leading those efforts. So we've got a dedicated resource now looking at business development and expansion, both in terms of our organic growth with our products, both whether it's pipeline or tenapanor itself, as well as looking at partnering that we can do in terms of bringing our pipeline in-house. So what I can tell you now, Massimo, is that we actually have a dedicated effort for doing this. Okay.
Because I know that the need in particular for kidney in Europe is very important. I launched Renagel in Europe.
I know, what does it mean giving to the patient 20 tablets per day, you know?
Do you have any estimates currently on what is likely to be the treatment persistence rate or average duration of therapy on XPHOZAH?
So good question. I mean, you look at the challenges for a dialysis patient, if you're aware of the handfuls of pills that they need to take. It's hard, right? Generally, and back years ago, I launched the Renagel program that Massimo and I worked together on in my days at Genzyme. And it's nearly impossible for those people to take the amount of binder that they need to take in order to absorb the phosphorus from their food. And you look at they're limited in terms of the fluid that they can ingest, as well as they're taking 10 to 12 other oral medications at the same time.
So persistence, adherence, compliance is fundamentally a challenge. We believe there's opportunity with two small pills a day that we can have a big impact on that. It's early days yet, and certainly now as we see the changes happening, you know, those are the things that we will focus on. It should be better, but it's premature at this point to say that it would be.
So another question, now thinking about XPHOZAH a bit more. You talked through a bit of the numbers behind the launch. I was wondering if you could talk about what were some of the drivers behind it.
I think the most important driver, thank you, Ben. I think the most important driver is, as I said in my presentation and you heard Massimo describe, it's really tough to manage your phosphorus if you're a dialysis patient.
You imagine the life that these patients need to lead. They go to dialysis three times a week because they have to. Their kidneys don't function. They want to live. They want to thrive. For so many people, food is love, and food is dangerous because of the phosphorus it contains. So you imagine trying to manage all those things every day, all the time with what you do, taking a binder with every time you put food in your mouth is extraordinarily difficult. The unmet need is there. We know that these patients will do better when they manage their phosphorus across many different issues that they deal with as patients on dialysis. So for us, that is what drives us is that incredible need.
The fact that we then also have its prior authorization, so what Eric described in terms of Ardelyx Assist and how we facilitate the prior authorization program, so that you, Ben, if you were the physician, you write a script now, last year or now, within the bundled payment system that's affecting so many patients, we don't want you to worry about whether I or any other patient actually gets a script. We have within our patient services program that we tell you, the physician, write the script. We will adjudicate. We'll figure out whether or not it's Medicare or not, and if it's not, the likelihood of getting coverage is high. If it's not, if it's Medicare, then you will be put into the patient assistance program. If you qualify, you will get the drug for free, and most people will qualify.
It's a really critical part of what it is that we're doing. We don't want the physician to be concerned because of what we've talked about, the need and how imperative it is that patients get their phosphorus managed. We don't want that to be a concern. We'll take care of that on the back end so you, the physician, never hear whether or not a patient has actually accessed the drug that you prescribed.
You now have two successful drug launches under your belt, which is quite the achievement. How do you think about continuing growth and using your pipeline to expand?
Exactly. I mean, if you look at what we're doing here, you look at the success that we've described of, you know, it's $1.7 billion at least between these two products. You know, that's almost two blockbusters, right?
And not many of us get the opportunity to even say that and think about it in a business like this. So for us, it is execution. We can't take our eye off the ball for both of those products. And as well, looking at what we bring in, I think what we've demonstrated in terms of our ability to build an excellent commercial organization is, we want to look for opportunities that can be put, whether it's our therapeutic areas or associated ones, or opportunistically other ones that we might look at, that we can apply our philosophies of how we commercialize our pharmaceuticals, apply them to that. I think that's what it takes. But it takes discipline and a lot of focus.
Great. Well, I think if there are no other questions, thank you all very much for coming.
Thank you all.