Sit by the fire.
Well said.
Okay, why don't we get started with our next presentation? Thanks everybody for attending. My name is Chris Raymond. I'm one of the senior biotech analysts here at Piper Sandler. Pleased to introduce our next presenting company, which is Ardelyx. We have with us the CFO and COO, Justin Renz. Also, Caitlin Lowie, who's the Vice President of IR, is in the audience. This is a fireside chat format, so very informal, and I would hope actually very participative. So if anybody in the audience has any questions, please raise your hand. I'll make sure it gets asked, registered on the webcast and all that stuff. We'll exclude names for anonymity, of course. But anyway, so we've got about 23-24 minutes.
Justin, maybe for the benefit of investors who don't know the story that well, if you could provide maybe a 2- or 3-minute setup on the company, you know, the elevator pitch, if you will, and then we'll dive into my questions.
Perfect. Well, thank you, Chris. Good afternoon, everyone. My name is Justin Renz. Pleasure to be here with Ardelyx today. Great conference here at Piper Sandler. We've had a great day of investor meetings all day. Excellent schedule. Beautiful day here in New York. Ardelyx is a biopharmaceutical company headquartered in Waltham, Massachusetts. We also have a sales location in Milwaukee, Wisconsin, and our original headquarters in Fremont, California. We have approximately 255 employees as of October 31. We have two commercial products, IBSRELA, for irritable bowel syndrome with constipation, and XPHOZAH for hyperphosphatemia, which is just what it sounds like, elevated levels of phosphate in your blood for adult patients on dialysis. I've been with the company now a little over three years, as Chris alluded to.
We are very excited about both of our programs, which we'll be getting into the detail during the course of this chat. IBSRELA we launched in April of last year. We did roughly $15.6 million in revenue in our first nine months of launch, and this year we've guided to between $76 million and $78 million in net revenue for IBSRELA. We are very pleased to announce the approval of XPHOZAH for hyperphosphatemia just over a month ago, October seventeenth, which we just started launching and selling this month. I'm sure Chris will be asking questions about that. We have, as of October thirty-first, $218 million in cash in our treasury, so we are extremely well-resourced for the launch, full steam ahead.
Both sales forces are fully deployed in the field all over this great country of ours, and trying to make things happen for the patient population.
Excellent. Okay, so maybe let's start with XPHOZAH. I just gotta say it's great to be here talking about XPHOZAH's launch in terms that are more than just abstract. It's been quite the journey, obviously, and so for folks who maybe aren't familiar with the regulatory saga, it's quite something. And so-
Yes, it is.
You know, maybe-
Do you want me to give the quick background, or now we move on?
Why don't we save it for when Mike
Okay
... writes it in his book.
Fair enough. So noted.
You know, about the experience.
Mike certainly can write a book.
So anyway, let's jump in with questions. XPHOZAH, obviously, you know, the first real novel, you know, phosphate binding, phosphate-lowering agent approved in the dialysis setting in 20+ years. You know, you launched it earlier this month. I wanna talk about the pricing decision. You know, obviously, you're pricing the drug at a premium to in a market that has a lot of competitors, a lot of generic entrants and a lot of generic players. But, you know, just maybe talk about the current economics in phosphate lowering or phosphate binders and the calculus that sort of went into this $35,000 per year WAC decision.
Yeah. Thank you, Chris. And you've been very supportive of this program from the get-go, so I share your thoughts on the approval. That was a great moment in our company's history to have the approval last month. Binders are just that. They bind your food in your gut. So if you have hyperphosphatemia, you have elevated levels of phosphate in your body that you cannot excrete like a normal, healthy kidney could. And so the invention really that Mike was a part of back in his days at Genzyme and our other team members, Rob, Liz, and David, with Geltex, for development, which is creating a gel Renvela, and they had great success together with that. It does. Just briefly, it binds the food in your gut.
So when you're having a diet, and unfortunately, we as Americans have high phosphate diets, these patients are unable to excrete it, and elevated levels of phosphate in your blood correlate to higher levels of morbidity and mortality. So binders have been the standard of care for many years, as you mentioned. There have been different innovations, if you will, but they're minor in the sense that they changed the backbone of how the binders work, but at the end of the day, they were binders. Our team discovered, developed, got approved, and is now commercializing XPHOZAH. And XPHOZAH's name, XPHOZAH, blocking phosphate. So we block phosphate from at- basically ever getting into your bloodstream. That's the, the, the thought behind it. So this is a novel innovation for patients. This is brand new. So we think about binders, binders have been generic for many times.
So the recent introductions, I'll say in the last seven years, of Auryxia and Velphoro, they are priced at a premium to the generic binders. So they range from roughly $1,400-$1,500 for Auryxia to roughly $2,300 per month for Velphoro, depending on your dosage strength and how many you take. So we believe with our novel drug, one small pill twice a day, is appropriate for the indication, in the sense it's a new innovation, it's second-line therapy to a phosphate binder, and again, with a novel mechanism, with the innovation, we feel our price is appropriate for how it's going to be utilized in the treatment paradigm.
So, we've assumed some degree of price elasticity in the space. You guys have done a lot more work. You've had, you know, arguably two years to think about this, right? With the FDA setback and the, and just, you know, the time. Is there something that you're seeing in the space that sort of, you know, that clearly there is, but what maybe if there's anything in particular you can talk about that.
Well, the most important thing for us is access. We want to make sure that XPHOZAH is available to the patient. For any nephrologist that writes a script, that her or his script gets filled. And so we have an innovative program we created called Ardelyx Assist, where we do everything we can to work with the prescriber to get the drug to the patient. And so that's an important investment to us. So on that front, we will have a generous commercial co-pay. So if you're a commercial customer, we'll pay the full amount of your co-pay at the point of sale. If you are less fortunate financially, we will do everything we can to provide that to you, perhaps even free of charge, through our generous patient assistance program.
So for us, the most important thing is for us to have a comprehensive plan to allow the patient to have access to the drug, and that was, of course, part of the overall pricing strategy.
Okay, so here's a question I doubt you'll answer, but I'm going to ask it anyway. And one last question on price. So given that you've had a couple of years, you know, really to think hard about this, is your decision on price any different now than it would have been had you had a first cycle approval?
You know, again, we don't try to play the hindsight game. You talked about how Mike can write his book. You know, I don't want to wonder what woulda, coulda, shoulda. We believe the price is appropriate for where we are today, and we're delighted that it's on the market and available for patients.
Okay, great. All right, so let's talk about. So you mentioned a generous co-pay program, and you also have a sampling program, the Ardelyx Assist, you know, program that you guys, you know, articulated when at launch and on your call. Kind of an interesting dynamic, and I find it intriguing. You'd mentioned that we'd be able to track the delta between, you know, pre-sample and paid prescriptions, given that Symphony will track all scripts, while IQVIA will track only paid scripts. So, you know, with sort of that visibility, how should we expect these two trends? You know, arguably, you're going to see a diversion happen early on, but then at some point you'll see a narrowing.
But, you know, just give a sense of how-- I'm not asking for specifics, but-
Sure.
You know, when you think about qualitatively, how those two lines ought to, you know, move together, you know, in the future, you know, as the launch, you know, sort of plays out.
So as a company, philosophically, I hope you'll, you'll see that we try to be as transparent as we can be, as a company, and that, you know, stems from Mike and, and how we want to be there for patients and not really hold back. And so to that regard, our prescription data is available on both, IQVIA and Symphony, every week. And so, as Chris alluded to, IQVIA primarily details revenue scripts, while Symphony shows all scripts. And so therefore, by definition, you can see the difference between the two would be non-revenue scripts. So that has, you know, been available over time since we launched the first week of April of 2022.
And you can see that there is a general gap between the two, but it has, I think, it's been relatively narrow over the last, you know, few quarters for sure, or at least a few months, if you want to look. XPHOZAH, we expect to be a little bit of a different dynamic. So, the IBSRELA market is roughly 60-65% commercial and 30%-35% non-commercial. So where-- what I mean by that is, with XPHOZAH, XPHOZAH is going to be more of the opposite, more 65% Medicare, Medicaid, 30-35% commercial. We are-- You're not allowed to obviously pay the co-pay of a Medicaid, Medicare customer. So as a result, we expect there be more, what I'll call, patient assistance program needs under XPHOZAH than there are in IBSRELA.
I would expect we would have more free drug, if you will, and we don't like to say that. It's really more of a benevolent patient assistance program-
Yep.
- for XPHOZAH than for IBSRELA.
Yeah. Okay.
Of course, we just started launching two weeks ago, so-
Mm-hmm
... you know, the end is minuscule.
So I think, you know, both organizations, Piper and Ardelyx, are fans of the Spherix's team. We use their data with a lot of the therapeutic silos that we cover. But, you know, their forte and their roots are really in the renal setting as you guys know. And we've been publishing on their data, you know, for a long time. And I find it interesting, and we were kind of struck. We did publish one of their pieces a couple weeks ago that showed that enthusiasm really hasn't wavered in that two-year span, right? Where FDA, you know, put this file on ice. Basically, they haven't forgotten.
And still the enthusiasm, if you took a snapshot, you know, in August of this year versus two years ago, is pretty much the same. So, you know, one thing that I guess, you know, kind of I worry about it in renal launches in general is, you know, enthusiasm is one thing. Actually writing, you know, a script is another. But, you know, talk about how, you know, your checks sort of square with that enthusiasm we're seeing and how you intend to sort of keep that momentum, you know, of that enthusiasm translating into actually writing a script. I know the Ardelyx Assist program certainly is one help, but, you know, at the end of the day, you know, getting the reimbursement wheels turning is clearly the key here, so.
No, yeah. No, great, great question. You know, by definition, if we're in this industry, we all should be optimists. So we're of course optimistic about the future of XPHOZAH and IBSRELA as well. Just pivoting back to IBSRELA for a minute. When we launched that after we had delayed launching that for a while, there actually was enthusiasm from several gastroenterologists saying, "I've been waiting for this for a while, too." So that was exciting to hear as well. The interest, awareness, enthusiasm in the patient community, the nephrology community, the kidney care community for XPHOZAH has been high since I joined the organization. To your point, there has not been a novel medicine in this space, a new treatment option for these patients for many years.
We talked about some of the branded binders that are nice additions to the treatment paradigm, but they're really not different. We offer a novel mechanism of action that I think the patient community, again, the pill burden of one small pill twice a day, we think is well received. You know, our Ardelyx Assist plan we have in place that has worked very well for IBSRELA, we're also going to use for XPHOZAH. So for us, it's all about granting access. So the enthusiasm that the Spherix data shows, we also show in our market research. That's why we wanted to make sure we are well-resourced, both from a treasury perspective as well as a supply chain perspective. So we have supplies made. We have a very nice, long shelf life, so we have... We're ready to go. We're planning for success.
The team is in the field, and their job is to, you know, convert this enthusiasm into scripts. So early days, a lot of enthusiasm, a lot of excitement. We hope that that holds true.
Yeah, I mean, just sort of speaking to the enthusiasm for folks who didn't see the survey that we published, we asked physicians: What would your share of this drug be six months out? And the answer came back 26% of patients, which that's insane. I mean, that would put that right behind Renagel and Renvela in terms of patient share. You're probably not going to see that kind of number, but, you know, I guess, you know, you guys know this field as an organization as well as anybody. You know, there tends to be sometimes an overestimation of use of new drugs, regardless of the physician's specialty. What's your view, as an organization of nephrologists? And, you know, I... A lot of reasons to take that kind of projection with a grain of salt.
But this is the first new innovation in a phosphate-lowering setting. Is there a reason to think that that's actually, you know, maybe not that number, but directionally, that kind of uptake patient share-wise?
Well, it's important to note, so in the United States, there's approximately 550,000 patients on dialysis. Of those, 80% require some sort of phosphate-lowering pharmaceutical intervention, so we'll call it 80%, roughly 440, to help you with the math. And then of that, within a six-month period of time, and these patients are seen regularly and have their bloods drawn, measurements taken, and roughly 70% of patients within any given six-month window are out of range of the KDIGO and KDOQI guidelines of 5.5 mg/dL or less. So there is a large patient population. The Spherix's data is very encouraging, very exciting. You know, we're flattered. We hope that, you know, she's right. That would be amazing, and we will do everything we can to try to make her projections come true.
The pace—the payers are going to put us through our paces, right? So again, the way our label, we are very happy with our indication, which is either add-on therapy to phosphate binders or if you no longer can tolerate a phosphate binder. And so that really is a pretty wide label because not only that combination data, but that also allows us to issue that, if you will, as a monotherapy, should the patient be unable to tolerate the binders. So there is a large market opportunity. We are going to make ourselves as available to the nephrology community. There's roughly of the market size, we are targeting the 80% of, you know, pardon me. 8,000 nephrologists write approximately 80% of the scripts. So we have a sales force of 60.
They're trained on the ground in the field as we speak, and they're targeting, you know, that's roughly 130-ish as a target per rep. We're going to do all we can to make those predictions come true.
So, I want to ask a little bit about the sort of healthcare policy effort. You know, this is a key issue that comes up with investors all the time, and it's around, you know, the potential of adding binders or phosphate-lowering agents to the bundle. I know you've got. There's a TDAPA sort of, you know, hall pass that you'll have for a little while. But there's a, I guess it's the bipartisan bill introduced in August that would delay implementation of the oral-only policy, you know, kick it back to 2033. You know, I guess maybe comment on how first of all it would be self-evident if it got thrown back to 2033.
But if it doesn't, and binders and phosphate-lowering agents get thrown into the bundle, one of the ideas I've had through all this is that that might not necessarily be a bad thing for you guys. It's, you know, along with being thrown into the bundle, yes, you have a price sensitivity sort of pushdown in terms of what folks are willing to pay. But along with that comes a QIP requirement, where centers have to have a certain number of their patients at goal. And so you could make it up on volume if in... That's, your drug is the only method by which docs can actually get patients to goal, which we've, you know, seen through real-life, you know, data that, you know, what is it?
50% of patients at any given time are at goal. So just kind of talk through that. You know, I know you guys have acknowledged that once it gets thrown into the bundle, that certainly creates some questions. But why doesn't the QIP requirement provide a tremendous offset?
Yeah, no, that's, that's great. I mean, we could, we could spend more than the time we have allotted-
Yeah.
for those of you who aren't familiar with it, I'll try to quickly kind of cover the landscape, because some folks may not be familiar with. So right now, on January first of 2025, oral medicines for chronic kidney disease patients on dialysis of all types are slated to go into the, what's called the bundle, the End- Stage Renal Disease Prospective Payment System. So, DaVita, Fresenius would get one payment per treatment from the government, and because all, dialysis patients are covered by Medicare Part D. Pardon me, B as in boy. Currently, it's Medicare Part D.
So right now, it's important that we are launching into a normal prescription market, so that we are doing everything we can to make XPHOZAH a part of a treatment regimen, something that is part of every patient to stay in compliance. So to your point, our goal is to make XPHOZAH a part of the standard of care, to help more patients get within the guidelines. Because should the bundle occur and we are placed in the bundle, we will, we will do everything we can to get to TDAPA, which should be something we would... Again, should this happen, we would apply for it in the second half of 2024 to make sure that we qualify for 2025 and 2026, certainly as a minimum, if you can see utilization.
But our goal would to be, do everything we can to have it part of the treatment regimen, because we believe, to your point, it would be, unethical to take a patient who is in range with the benefit of our therapy and take them off to save some money. So there is potentially a price-benefit issue that we'll have to deal with. To Chris's point, Buddy Carter introduced a bipartisan bill on July 28th. It's currently in front of Congress. It needs to be scored by the Congressional Budget Office. Our Congress, of course, is not even in session, I think, as we speak. So we have no sense of timing on when this could advance or how this would advance.
It's been extended three different times, and we believe it's in the best interest of patients to not have phosphate-lowering therapies entered in the bundle, because even the logistics around how that would be administered. But irrespective of all of that, the goal right now is to bring kind of your last two questions together, is to make sure access is available for as many patients as possible, get them on drug, have them have a pharmaceutical benefit, a health benefit, have them part of their daily regimen, because this is chronic therapy. And then hopefully, the quality measures as they evolve, they'll our drug exposure will be part of that to make sure the patients are within range, and that's good for-
Yeah.
- All people.
Okay. All right, cool. So let's, let's maybe transition to IBSRELA. You know, obviously another success story, I guess, arguably commercially for you guys. You know, keeping with the Spherix, the survey, theme, this is another. They've done another sort of body of really nice work in the, in the gastro space and have shown some very real, tangible, solid gains. I think by September, you guys had 6% patient share in a, you know, what's a huge market.
Interesting how, however, you know, Spherix asks this question every single time: "What's your share going to be in six months?" So it's always basically within six months, share will double, and we go another month and it, and you keep kind of moving forward in the timeline, and they're overestimating, but they haven't lost their enthusiasm. So I guess, you know, what's your sense of that? I know you guys get that data too-
Sure.
You've got other sources of data in terms of what's going on with the market. What's your sense of the disconnect between that very near-term share projection, and it just hasn't yet panned out, even though share has gained, has gone up?
Yeah. So in the United States, there's approximately 5 million scripts written each year for IBS-C. Linzess is by far the market leader, great drug, and Ironwood and Forest, now AbbVie, have done a great job in creating that market, if you will, for the space. We do not compete with Linzess. We are second line, and so our basic premise is, if Linzess or Trulance or something else is not working for you, usually the requirement by the payers is one GC-C agonist as a prior auth. Would you like to try something new? And our drug is a novel mechanism, novel agent, and that is where we are targeting. So there's roughly 30%, plus or minus, of patients who are not having their needs well served. That's our target audience.
So we initially, when we launched, we thought we could get mid-single-digit share. In our Q3 earnings call, we've increased our enthusiasm and say we now think we can get high single-digit share. So our goal is, again, if we can get a third of that third, you know, there's, you can see how there's roughly a 10% math there. So we're going to just be persistent and consistent in our growth. We're trying to get new prescriptions and repeat prescriptions regularly. So a couple of weeks ago, we had our most new prescriptions ever published, and a week ago, it came out, our highest, you know, refill prescriptions ever came out. So the goal for the team, and we've increased the sales force from 34 to 64. It's a promotion-sensitive market. We've found that if we can hit these high-writing GIs, we really can make an impact.
So I think our goal is to achieve that market share that's been presented and, you know, do everything we can. I can't speak to how, you know, they come up with their math.
Okay, great. So one more question till we run out of time, and I guess that's around guidance. So in August, and I think that at that time point, you were about six quarters into the IBSRELA launch, you issued guidance for the first time. Maybe this is a two-part question. Just remind us maybe, you know, your thoughts there, and how we should expect your guidance sort of cadence to sort of evolve over time. And is that a reasonable thing to anticipate, you know, for exposure, that, you know, you'd have to have, you know, at least a year of experience before you start guiding on that important brand?
Sure. So with IBSRELA, we launched again in April of 2022, and so on our June 30 earnings call, so roughly August of this year, we issued guidance that we thought we could do between $72 million and $77 million. And then that we narrowed, increased that to $76 million-$78 million on our Q3 call. We believe that is within range. So as Chris alluded to, it took us 4-5 quarters to issue that guidance. We're very excited about the exposure opportunity. We just launched that this past month. I think we're going to need to have some more experience and more data before we give guidance. It's our goal as a company to be transparent and share guidance when we feel like we're well prepared to give you a good estimate to help you and your, your customers, you know, understand the market opportunity.
We'll always be measured and thoughtful in our guidance and try to be consistent in our disclosures.
All right, great. Well, we're out of time. Thanks for that, that great presentation, Justin. Thank you.
Thank you.