Ardelyx Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 1, 2025
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Operator

Day, everyone, and welcome to the Ardellix First Quarter twenty twenty five Earnings. All participants will be in a listen only mode. Now I'd like to turn the conference over to Caitlin Lauwy, Vice President of Corporate Communications and Investor Relations. Caitlin, you may begin.

Caitlin Lowie
Caitlin Lowie
Vice President, Corporate Communications and Investor Relations at Ardelyx

Thank you. Good afternoon, and welcome to our first quarter twenty twenty five financial results call. During this call, we will refer to the press release issued earlier today, which is available on the Investors section of the company's website at ardells.com. During this call, we will be making forward looking statements that are subject to risks and uncertainties. Our actual results may differ significantly from those described.

Caitlin Lowie
Caitlin Lowie
Vice President, Corporate Communications and Investor Relations at Ardelyx

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 ardells.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 Robb, will begin today's call with opening remarks and an overview of the company's performance during the first quarter of twenty twenty five. Next, Chief Commercial Officer, Eric Foster, will provide an update on the performance of Astrella and Exposa. Justin Rents, Chief Financial and Operations Officer, will conclude today's prepared remarks with a review of the company's financial performance during the first quarter ended 03/31/2025, before we open the call to questions.

Caitlin Lowie
Caitlin Lowie
Vice President, Corporate Communications and Investor Relations at Ardelyx

With that, I'll hand the call over to Mike.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Good afternoon, and thank you for joining us today. We're pleased to share an outstanding start to the year at Ardellix. We've made excellent progress across all of our priorities and continue to build significant momentum while navigating a rapidly changing and dynamic marketplace. As compared to the same period last year, we generated revenue growth of 61% totaling $74,000,000. This is noteworthy.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Our teams are building clinical conviction for our therapies and serving more and more patients with these two important therapeutic options. We have successfully launched two products during the last three years, and we're delivering on our mission. Now starting with IBSRELA. IBSRELA's exciting growth trajectory continues. We delivered one of the highest prescription demand quarters to date during the first quarter, reinforcing our confidence in IBSRELA as a differentiated, important, and valuable treatment for patients.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Israel has significant long term potential supported by a large and growing market and continued unmet need among patients who remain inadequately served by secretagogues. Our commercial team is effectively driving prescriber adoption by building clinical conviction among high value targets, while our expanded field access management team is enhancing patient access and pull through. Together, these efforts are positioning the drill for sustained growth and deeper market penetration. We are on track to meet our 2025 guidance of $240,000,000 to $250,000,000 in net sales, and we have a clear path to achieving peak annual net sales revenue of over $1,000,000,000 Now turning to XPOVIO. During the first quarter, XPOVIO grew by 30% compared to last year, not including the onetime gross to net adjustments for return reserve release.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

This performance reflects the clear unmet need that exists for patients, the growing role for Exposa is playing in helping patients achieve and maintain target phosphorus levels, and the remarkable momentum our team built in 2024. It is important to recognize that with the loss of Medicare Part D coverage for phosphate lowering therapies, the dialysis market is undergoing significant disruption, and it is causing increased frustration among both nephrologists and patients. Our decisions around Expose remain firmly grounded in a commitment to patient care. Amid this uncertainty, we're encouraged by early signals. Patients across both Medicare and non Medicare segments are successfully accessing the therapy, and real time feedback from the field reinforces Expos's clinical value.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

As the environment remains fluid, we are not yet providing formal revenue guidance at this time. Instead, we are closely monitoring uptake and market dynamics, and we will provide further updates as the landscape continues to evolve. Across the board, Ardellis continues to execute with resolve, discipline, and agility, and we're making progress in our strategic priorities, driving strong commercial execution for Ibsrela, navigating the access complexities and generating important commercial momentum with Exposa, building a pipeline to unlock long term growth and continually delivering on a strong financial performance. Our high performing team, differentiated products, and commitment to patient centric innovation position us to lead and grow in a rapidly evolving health care environment, and we remain steadfast as we build long term value for our shareholders. Thank you for your continued support and confidence in Ardellix, and I will now hand it over to Eric to share his perspectives on our commercial performance during the first quarter.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Eric?

Eric Foster
Eric Foster
CCO at Ardelyx

Thanks, Mike, and it's great to be with you all again. Q1 was another great quarter for both products. Ibsrela and Exposa delivered meaningful year over year growth. Consistent with prior q ones, we saw the IBS C market contract and as you know, the hyperphosphatemia market was impacted by the elimination of Medicare Part D coverage for phosphate lowering therapies. Despite these headwinds, we saw strong prescription demand for IBSRELA and demonstrated that both Medicare and non Medicare patients are able to access Exposa as we continue to meet the unmet need in the market.

Eric Foster
Eric Foster
CCO at Ardelyx

The team is focused on execution and building on our q one momentum as we enter an important second quarter in a position of strength. Let me start with Ibsrela. Ibsrela grew 57% over last year. This is incredible growth as we enter our third full year post approval. We saw increases across key demand indicators, including new and total riders and new and refill prescription.

Eric Foster
Eric Foster
CCO at Ardelyx

As I mentioned before, the IBS C market historically contracts during the first quarter and we saw clear evidence of it in Q1, especially early on. Despite that contraction, Ibsrela demonstrated strong prescription demand consistent with Q4 and exited the quarter with very strong momentum. This is further evidence of the confidence that HCPs have in IBS C and the value this medicine can bring patients. As we look ahead, we remain focused on making progress against our strategic imperatives to drive growth and help more patients with IBS which include raising awareness and favorable perception of IBS C, expanding target HCP's view of potential IBS C positioning IBS C as the first action for appropriate patients who are not getting adequate relief or are not satisfied on a secretagogue and encouraging HCPs to send prescriptions to one of our specialty pharmacy partners or Ardellix Assist. These strategic imperatives are allowing us to create opportunities across all aspects of the physician and patient journey to improve HCP perception, drive consideration, and support prescription pull through.

Eric Foster
Eric Foster
CCO at Ardelyx

Our expanded field based teams and our omnichannel marketing initiatives are focused on these areas, and we continue to see improvement. Ipsrela is an important treatment option for patients with IBS and we remain confident in our path to greater than $1,000,000,000 peak year net sales revenue. Now on to Exposa. Exposa had another very strong performance, delivering 30% revenue growth compared to last year when you exclude the returns reserve release. This demonstrates that Exposa continues to be an important medicine to help patients achieve and maintain target phosphorus levels despite the turmoil and disruption in the market.

Eric Foster
Eric Foster
CCO at Ardelyx

It also gives us confidence that Exposa strategy is working. Most importantly, the operational plan has allowed patient access to continue. We're driving a clear message to health care providers that is resonating. Prescribe as you always have based on the patient need, and we will support access through our patient services programs. As we look at Expose's performance during the quarter, there were several positive indicators that gives us confidence as we move forward.

Eric Foster
Eric Foster
CCO at Ardelyx

We saw new riders prescribing during the quarter as well as both new and refill prescriptions continue. In addition, our internal market research indicates that the vast majority of surveyed nephrologists recognize they are the decision makers for Exposa prescriptions and that they continue to believe that at least thirty percent of the patients are candidates for Exposa. To maintain the momentum that the team has established, we must remain focused on the factors that influence our ability to drive demand. There is a high unmet need among dialysis patients for tools to achieve and maintain target phosphorus levels. Physician satisfaction with Exposa remains high.

Eric Foster
Eric Foster
CCO at Ardelyx

Access to Exposa has been protected. And lastly, we have a strong share of voice in the market. The commercial team and all of team Ardellix have been steadfast in our commitment to bring these first in class medicines to patients who continue to struggle with their conditions. We have a winning position in two markets with a high unmet need and a high performing team that consistently drives results, and we are eager to achieve our potential as quickly as we can. We are focused on executing our plan and maintaining the growth momentum for the remainder of the year.

Eric Foster
Eric Foster
CCO at Ardelyx

I will now turn it over to Justin. Justin?

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

Thank you, Eric.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

We were very pleased with the financial performance we reported earlier today, which demonstrated significant year over year revenue growth, careful management of expenses to support continued commercial excellence, and a strong cash position to continue building the business. We had total revenues of $74,100,000 in the first quarter of twenty twenty five, an increase of 61% compared to the $46,000,000 we reported last year. The growth was driven primarily by strong performances and significant increases in net product sales revenue from both of our commercial products in the first quarter of twenty twenty five compared to the same period of 2024. During the first quarter of twenty twenty five, we recorded Ibsrela net sales revenue of $44,400,000 an increase of 57% over the same period of last year. Our growth was driven by strong patient demand and the continued focus on commercial execution from clinical consideration to prescription pull through.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

As we have consistently shared with you in the past, our net sales were impacted during the quarter due to normal Q1 market dynamics. In line with our expectations, the gross to net deduction for IBSRELA for the quarter was 34.8%, and as we've experienced, we expect this to improve throughout the course of the year. We expect continued growth for Ibsrela, and we reaffirm our 2025 guidance of $240,000,000 to $250,000,000 in net product sales revenue. We also recorded $23,400,000 in net product sales revenue of Exposa in the first quarter of twenty twenty five, an increase of approximately 55 compared to $15,200,000 in the first quarter of last year. As you saw in our press release, Exposa net sales revenue includes a one time $3,800,000 release of our returns reserve.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

Excluding this returns reserve release, our year over year growth for Exposa was 30%. Our returns reserve considers our returns policy and the passage of time since launch. When coupled with zero product returns to date in our open return window and the very low number of bottles in our downstream distribution channel, it was clear that a returns reserve is unnecessary. As a result, our gross net deduction for Exposa during the first quarter was approximately 18%. Excluding the impact of this release, it was approximately 32%.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

In addition to product revenue, we earned a $5,000,000 milestone from our partner in China following the approval of cannabinoid for hyperphosphatemia. We received payment from Fosun Pharma in April. We also recorded $1,000,000 in noncash royalty revenue during the first quarter of twenty twenty five compared to $370,000 in the same period last year. Research and development expenses were $14,900,000 for the first quarter of twenty twenty five compared to $10,600,000 for the same quarter of the prior year. The increase in R and D expenses reflects increased engagement with the scientific and medical communities.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

Selling, general and administrative expenses for the quarter were in line with our expectations at $83,200,000 compared to $53,000,000 that we reported for the same period in the prior year. The increase was related to commercial activities for Ibsrela and Exposa, including the Ibsrela sales force expansion, as well as growth of the overall corporate infrastructure to support our strategy. In the first quarter of twenty twenty five, we also had $12,100,000 in non cash stock compensation expense and $2,100,000 in non cash interest expense. We had a net loss of approximately $41,100,000 or $0.17 per share in the first quarter compared to a net loss of $26,500,000 or $0.11 per share in the same period of last year. As of 03/31/2025, our total cash, cash equivalents and short term investments was $214,000,000 The first quarter demonstrated strong demand for Ibsrela and clear evidence that the EXFOSA strategy is working.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

We remain confident that there is a significant opportunity for both of our medicines and we are on track to achieving our peak sales expectations. More than $1,000,000,000 for IBSRELA and $750,000,000 for EXFOSA. We are building a great company and focused on delivering shareholder value. With that, I'll hand it back to Mike.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Thanks, Justin. It has been quite an eventful first quarter, and through all of it, we executed and created opportunities. That will continue to be our focus moving forward. I will now open the call to questions. Operator?

Operator

Our first question comes from Louise Chen of Scotiabank.

Louise Chen
Managing Director at Scotiabank

Congratulations on all the progress this quarter. I wanted to ask you two questions here. First, for the IBS C market, do you expect this to improve as you go through second quarter and beyond versus the contraction that you historically see in the first quarter? And how should we see that play out? And then secondly, could you explain in more detail the return reserve and how that impacts the sales and what that could look like going forward?

Louise Chen
Managing Director at Scotiabank

Thank you.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Sure. Let me ask Justin to start with the second question first.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

Thanks, Louise. Yes. So as part of our gross to net, we have a returns reserve. And our returns reserve, again, is contemplated from the beginning of launch. When you couple our progress over the last five or six quarters where we've had zero returns and very limited bottles in our downstream distribution, it was no longer appropriate to carry this reserve on our balance sheet.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

So we will no longer be doing this prospectively, and this, of course, would have modest improvement to our gross to net prospectively.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

Eric?

Eric Foster
Eric Foster
CCO at Ardelyx

Yeah. Thanks Louise for the question. With regard to the IBS C market improving as we go through the year, the short answer to that is yes. The IBS C market in the first quarter we know traditionally contracts and that's exactly what we saw early on in Q1.

Eric Foster
Eric Foster
CCO at Ardelyx

But we continue to remain very optimistic given that we had our highest prescription demand quarter in q one. We were able to I'm sorry, in q four, and we were able to see that that consistent, in in q one. And certainly, we're able to finish the quarter with strong momentum that gives us a lot of confidence as we move into Q2 and the rest of the year that we'll continue to see that improve.

Caitlin Lowie
Caitlin Lowie
Vice President, Corporate Communications and Investor Relations at Ardelyx

Thank you. Thanks, Louise.

Operator

Our next question comes from Ryan Deschner of Raymond James.

Ryan Deschner
Ryan Deschner
Vice President - Equity Research at Raymond James Financial

Hi, thanks for the question. Just wanted to ask a little bit more about the 1Q contraction. What are you attributing to sort of this level of overall contraction in 1Q? And and is it looking different from prior 1Q situations?

Ryan Deschner
Ryan Deschner
Vice President - Equity Research at Raymond James Financial

And then then I have a follow-up. Thank you.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Sure. Thanks for the question, Ryan. I I think just for some context is the market has consistently contracted. Think in their first two years on the market, the volume that we were generating, probably not as much of an impact. But as this business grows, as Eric I'll ask him to address it, it's something that we are expecting, as we move forward.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

I think if you compare us to others within that market basket, I'm pleased with the performance that we saw out of Adrella. Eric?

Eric Foster
Eric Foster
CCO at Ardelyx

Yeah. I would just add as we continue to grow volume, we're starting to see a bit of a response similar to that of the market in the first quarter. But it's still a very healthy market continuing to grow double digit growth as it has over the past few years. And as I mentioned just a minute ago, we expect that to continue to grow in 2025 for the rest of the year.

Ryan Deschner
Ryan Deschner
Vice President - Equity Research at Raymond James Financial

Got it. And then what are you targeting for your long term gross to net if you're disclosing a level for Exposa at steady state? And also, do you have any color or or a status update on the launch in within China now that it's approved? Thanks.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Yeah.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

So the China First, you know, once we get more perspective from our partner, we can share that. So probably not much to talk about there and Justin if could address the gross net.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

Sure, it's still early because we're in the new treatment paradigm if you will. The coverage mix where is changing in 2025 compared to 2024. So we're not really fully there yet. I I would say, you know, we had 32% irrespective of the gross to net change we made for the returns reserve in q one.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

I think it's fair to say, Ryan, and Justin correct me if I'm wrong, is that generally our guidance for both at 30% plus or minus 5% is likely to hold true continually going forward.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

That's a great place to start modeling.

Ryan Deschner
Ryan Deschner
Vice President - Equity Research at Raymond James Financial

That's very helpful. Thank you very much.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

Thanks, Ryan.

Operator

Our next question comes from Dennis Deng of Jefferies.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

Hi. Thanks for taking our questions. Two for me. On Ipsurella, I mean, how do how do you guys reconcile what's being reported through IMS and the 44,000,000 in revenue that you guys reported? Because, you know, based on scripts and I think through some reasonable assumptions, I think people are expecting around 52,000,000.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

So the 44,000,000 was quite a surprise to us. And then question number two is on the CMS litigation on Exposa. When do you expect the decision on the appeal? And I guess, hypothetically, if there were a positive decision and Exposa was given back part b, how quickly can things be restored back to twenty twenty four levels in terms of the underlying structural logistics at the DOC? Thank you.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Well, that I'll address the last question first, Dennis. I mean, it's probably not healthy to get into hypotheticals just given everything that we're seeing going on in Washington. All the briefs that need to be filed are filed, and we're just waiting for the courts to set a date. And, you know, we will navigate through that. And as we learn more, we will certainly, bring it to your attention.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

I'll ask, Eric to talk a little bit about your question around scripts. But remember, as we've talked about this over the years, that there are going to be fluctuations in scripts, which is why what we said consistently is you need to hold us to account for the guidance that we give you. And as you heard all of us say, we are confident that two forty to two fifty. And the perturbations in the first quarter are part of the reason that that we encourage you to look at it as such. Eric, any thoughts?

Eric Foster
Eric Foster
CCO at Ardelyx

Yeah. Thanks, Dennis. Good question. You know, as we think about demand, we were very pleased with what we saw in q one. As I noted, consistent with what we saw in q four, which was our highest demand quarter to date.

Eric Foster
Eric Foster
CCO at Ardelyx

Certainly, when you look at net sales, it can be impacted by market dynamics. When we think about q one, we typically typically see things like the IVSE market contract. We've got prior authorization renewals, insurance coverage resets, wholesaler buying patterns, and higher patient co pays, and all that needs to be taken into consideration. But what gives us confidence is we've seen that in the past. We also see that it normalizes, and we feel like we really ended the quarter with strong momentum and certainly feel very confident as we go into q two.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

And then, Dennis, I think what's important about that strong momentum, q one was our second highest generation of demand to date. Right? So what Eric just described certainly is is I'm sure from the perspective that you're bringing frustrating given the numbers that you thought, but we're extremely happy with the performance that we saw particularly since this is the second highest demand. And we were not impacted by the contraction the way other products were in the IBS C market basket.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

Got it. Thanks.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Thanks, Dennis.

Operator

Our next question comes from Laura Chico from Wedbush Securities.

Analyst

Thank you very much for taking our question. This is Dylan on for Laura Chico. I was wondering what metrics are you monitoring to assess the impact of the newly expanded Israelis field force? And what gives you confidence that you're on a trajectory to meet the peak peak revenue expectations?

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Sure.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

If first of all, is I think the caliber of the people that we've hired and what we're seeing already coming out of the first the fourth quarter, excuse me, fully on board and trained, gives us that confidence. You know, as I just said, Dylan, that this was the second largest quarter of demand generation that we've seen since launch. That is part of the confidence I get in it. In the midst of that market contraction, as I said, we contracted less than the others. That gives me confidence.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

The incredible unmet need need that's out there and the better access that we have with a larger sales organization, I think all comes together. Eric, other thoughts?

Eric Foster
Eric Foster
CCO at Ardelyx

Yeah. You know, for me, I mean, what I think about is is really three things. Are are we seeing an increase in activity? Are we seeing an increase in riders, whether we total riders or new riders? And then are we seeing that lead to new and and refill prescriptions?

Eric Foster
Eric Foster
CCO at Ardelyx

And as it relates to year over year, we certainly see, significant increase in activity. We see an increase in new and total riders, and then we also see an increase in the new and the refill prescriptions. As Mike mentioned, q one is the second highest demand, prescription demand quarter to date, and there we saw an increase in total riders as well as new and refill, prescriptions, looked really good coming off of, what Mike said was, you know, our our highest demand quarter in q four. So those are some of the basic metrics that we look at to make sure that we're getting the activity that we need that's generating new and total riders that's leading to new and refill prescriptions so that we can help the higher number of patients out there that that need this treatment for their IBS C.

Analyst

Thank you.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Thanks, Owen.

Operator

Our next question comes from Joseph Tome of T. E. Cowen.

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

Hi there. Good afternoon. Thank you

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

for taking our questions. Maybe the first one, can you comment a little bit on the demand specifically in the commercial channel and how that changed from q four to q one for Exposa just to kinda get an idea of growth in in that segment? And then a question on the financials. When we look at the r and d and s g and a spend for this quarter, should we use this as sort of a new base going forward? And maybe relatedly, how much wiggle room do you have in the spend for Exposa to make sure, you know, that business stays profitable, going forward depending on what

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

we see this year? Thank you.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Sure. Let me ask, Justin to address the second part of your question first.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

Great. So thanks, Joe. Yes, we had modest increase in our SG and A in Q1 compared to Q4, so you might have seen an increase from 76,000,000 to 83,000,000 And we expect to that will rise over the course of 2025 to around ninety million by the end of the year, making sure we have all the appropriate team members to support the commercial team. And to your point, make sure Exposa and all the patient access and everything else is available through either our patient assistance program, our field managers, and everything in between. So we feel like that is in good shape and some modest increase over the next few quarters.

Justin Renz
Justin Renz
Chief Financial & Operations Officer at Ardelyx

From an R and D perspective, we were approximately $15,000,000 in the first quarter, and we expect modest growth in that over the course of the year. So we're in great shape. Again, we finished the quarter with $214,000,000, and and we're in good shape for a financial position.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

And and Joe, just to clarify, your question is more than just commercial. It's the non Medicare segment. Right?

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

Correct.

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

Yeah.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Okay.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Yeah. Eric, if could address that.

Eric Foster
Eric Foster
CCO at Ardelyx

Yeah. Thanks, Joe. You know, what we saw in q one was we saw that Medicare had about a weighted average of around 13% of the total payer mix. You know, we think about that. We saw that it was primarily in the first few weeks.

Eric Foster
Eric Foster
CCO at Ardelyx

Fortunately, these patients had the benefit of a one time transitional fill through CMS, and we saw that take place. And like I said, it was primarily in the first few weeks. But what we saw as the quarter continued to move was the the the rest of the mix was really predominantly through the commercial and the Medicaid side, which as you know is the non Medicare mix. So we were able to see, a good momentum there as the quarter continued and feel really good about where things ended, at the end of q one, and that's given us continued confidence as we move forward, and really focusing on being able to to allow all patients regardless of whether it's Medicare or non Medicare be able to have access moving forward.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Yeah. I I guess just one follow-up to the financial question is, it's not that we're necessarily looking for wiggle room. I think we have incredible confidence on the trajectory that we're on with Exposa in the way that we've approached, the market. So not that we're looking for wiggle room, think we're on track with what we anticipated, which is why we we reaffirm the 750,000,000 peak. And, you know, the hope is an expectation that in the not too distant future, we can give you more perspectives of what our views are for this year.

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

Great. Thank you very much. Very helpful.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Thanks, Joe.

Operator

Our next question comes from Breanna Reese of Leerink Partners.

Roanna Ruiz
Senior Managing Director, Biotechnology Analyst at Leerink Partners

Hey. Afternoon, everyone. Follow-up about Exposa. I'm just curious, are the do you have any updates on the how the patient assistance program is operating right now and some of plans to keep going forward into February and March? And the second part of it is, I was also curious of off the last question, thinking about commercial and non Medicare, how are those trends possibly tracking into exiting 1Q and thinking about 2Q and 3Q?

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Sure. Let me ask Eric to address this for you.

Eric Foster
Eric Foster
CCO at Ardelyx

Yeah. So thank you. So with regards to PAP or the Patient Assistance Program, we're very pleased with how the Ardellix Assist is being able to help patients in need, particularly those Medicare patients. You know, we saw patients that were on, Exposa for Medicare Part D in q four. They were able to continue accessing, accessing Exposa in q one through our patient assistance program.

Eric Foster
Eric Foster
CCO at Ardelyx

So I would say we were very pleased with, being able to help those patients out and certainly new patients as they come on in in first quarter. We are in this for the long term. For us, it's paramount that we, are able to provide access for those patients in need. And so we're not looking at it on a quarterly basis. It's not a q two, q three, q four decision for us.

Eric Foster
Eric Foster
CCO at Ardelyx

We're continuing to move forward so that all patients regardless of Medicare and non Medicare have coverage, for, for Exposa. With regards to the commercial business, again, very pleased with what we're seeing there on the non Medicare segments. As I noted, you know, we saw, really the the vast majority of the the Medicare trans transitional fills within the first few weeks, But really that dissipated, and we really aren't factoring that into, our models as we look at things and we forecast moving forward. It's really, focused on driving that non Medicare business primarily through commercial Medicaid and and the VA business that we saw really increase in that that latter half of q one, and that's what's given us confidence as we move into the remainder of the year.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

I mean, just a couple of comments on that, Ron, is if you the confidence that we have coming from January where, you know, everything everyone was wondering how this was gonna work. And then as it progressed through to March, you know, the strategy is working. I think no one can underestimate the impact on these patients of the turmoil that they're facing and suddenly having to get their binders through the DOs. Some of the binders that they've been on for a long time aren't available, and ultimately us having to work and choosing to work with a nephrologist at the center of the decision making as they were before in the midst of all this turmoil. I'm very pleased the way that the team has actually helped them navigate through it, and the strength of the Ardellix assist team and the program there in particular is is is paying dividends.

Roanna Ruiz
Senior Managing Director, Biotechnology Analyst at Leerink Partners

Got it. Thanks for the help.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Thank you.

Operator

Our next question comes from Julian Harrison from BTIG.

Julian Harrison
Managing Director at BTIG

Hi. Thank you for taking my questions. When you look at high volume IBS C prescribers, are you left with the impression that they generally know who the best candidates are for Isbrella? And I ask this because I I, you know, am aware of some recent survey data you guys have suggesting a disconnect between prescribers and patients on how large the unmet need is. And, you know, I'm also just wondering how you expect maybe the gap to narrow there going forward.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Yeah. I mean, just one quick comment. I'll ask Eric to address it. A disconnect between prescriber and patients is probably a pretty traditional phenomenon across many therapeutic areas. And, you know, to me, at least with what I see, the significant untapped potential that's out there is remarkable.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Don't forget that all of our clinical work was first line therapy. And the fact that a new mechanism like this, given payer dynamics, is what forces you into making the decision we did because we didn't wanna negotiate with payers that we would be second line is what gets us to where we are. The dissatisfaction when you talk to patients with what they have with GCC agonists, kinda hard when a physician doesn't yet understand this new mechanism and what it is that we can provide that they may see a disconnect between the patients thing. But that's the work and why we expanded the the field and the and the yields that we're seeing from that effort. Derek?

Eric Foster
Eric Foster
CCO at Ardelyx

Yeah. I would just add there there certainly is plenty of opportunity out there. You you mentioned the disconnect, and we're very much aware of that and and really take it very serious in in our responsibility to help connect the physician and the patient. You know, I think patients, or physicians, they they do recognize, who these patients are. It's actually you know, when we talk to physicians, it's patients that are diagnosed with IBS They're currently on a secretive drug therapy, and yet they're not satisfied or they're not getting that relief.

Eric Foster
Eric Foster
CCO at Ardelyx

For us, it's really trying to get the physician to act with urgency. You know, they've been writing secretive drugs now for a decade, and so we need to continue to try to break these habits. It's getting them to recognize the appropriate patient. I think we're we feel like we're getting traction there. But then it's really acting with urgency so that they can be the first choice once that patient really, is not satisfied or they're not getting adequate relief.

Eric Foster
Eric Foster
CCO at Ardelyx

We know that's quite a few patients because we know about a third of those patients out there are satisfied. So that leaves quite a few patients out there that are currently diagnosed on a treatment not satisfied and getting adequate relief they were seeing Entrella being used really second line for those patients.

Operator

Our next question comes from Aden Hizina from Ladenburg.

Aydin Huseynov
Equity Research Analyst at Ladenburg Thalmann & Co. Inc

Hi, good afternoon, Congratulations with this quarter. I got a couple of questions. So appreciate you exposed this long term guidance confirmation, $750,000,000. So could you provide some dynamic of sort of how you plan to get there, sort of ramp up curve? And if possible, 2025 sort of soft guidance kind of hints.

Aydin Huseynov
Equity Research Analyst at Ladenburg Thalmann & Co. Inc

And does the long term guidance not include Medicare? And in case you'll be able to sort of include Medicare, further on, would how would that, actually, affect the upside for for as well as sales, peak sales?

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Sure. Let me address that for you is we assume Medicare is not part of the mix in terms of paying for Exposure for those patients. That's roughly sixty percent of the dialysis population is, Medicare. Non Medicare is primarily Medicaid and commercial. And the comments from both both Eric and I that what we see already in the first quarter makes us feel confident that that is going to be what we are able to and confidently get to $750,000,000.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

As we've said last year, as we were entering this year and reaffirmed in in my opening comments, it's too early for us to be giving you guidance as to what 2025 is gonna look like. We are you know, once we have confidence, and I believe it will happen, you know, in the not too distant future, we will provide you some perspective as to what we think 2025 will turn out to be.

Aydin Huseynov
Equity Research Analyst at Ladenburg Thalmann & Co. Inc

Thank you. I appreciate that. And one follow on question. It's how much of the decision making by nephrologists may affect, the insurance coverage? And have you have you seen any pushback from payers so far for exposure given your sort of an ongoing negotiations with, CMS?

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Sure. Well, payer and CMS probably not correlated, two very separate things. The nephrologist and the HCPs are extremely important as it relates to getting prior authorizations through. Eric, other thoughts?

Eric Foster
Eric Foster
CCO at Ardelyx

Yeah. I would just say, you know, right now, we're really not seeing any pushback on the commercial side. And it's and it's good to see that the nephrologist still has the the ownership and and really is at the decision, the center of the decision making. And for those patients that need it, if they have commercial coverage, then certainly, the physician can write for it and we've got confidence that the the patient can get it on the commercial side. How's going?

Eric Foster
Eric Foster
CCO at Ardelyx

As well as others.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

And our Adult Assist program is extremely helpful in navigating that process.

Aydin Huseynov
Equity Research Analyst at Ladenburg Thalmann & Co. Inc

Alright. Thank you. Thanks so much.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Thank you.

Operator

Our next question comes from Allison Bratzel from Piper Sandler.

Analyst

Hi. Thanks for taking the question. This is Ashley on for Ali. Ali Bratzel. I had two questions.

Analyst

First one being related to Exposa. It seems like we haven't really heard much about the Kidney Patient Act. It seems like this is kinda shaping up to be what you would call a call option. Do you have any updated color on that front? Anything you've heard?

Analyst

And then my second question is related to potentially bringing in a GI or renal adjacent external asset. You guys previously signaled some interest in doing that. Is that still the plan? Do you have any color on when we might hear about this? Are you kind of focused more on the ongoing launches with your commercial products?

Analyst

Anything on that front would be really helpful. Thank you.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Sure. Thanks for the questions. In terms of bringing up assets as we've described, you know, we we've recently built out a team with Mike Kelleher to look at corporate development and licensing acquisition of of assets, certainly in direct, in our spaces in renal and GI and adjacent spaces as appropriate. And that work continues. We're excited about progress is being made and, when there is something to talk about both in terms of internal development of of some of the approaches we could have with programs that we have developed.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

We will announce that as anything that we bring in from the outside. So it's an incredibly important part of our efforts to build this enterprise, as we believe we can. As it relates to the QNE Patient Act, you hit the nail on the head. Think of it as a call, free call option. You know, what we at the end of last year, we communicated is that you should hold our feet to the fire around the $750,000,000, and that comes from forty percent of the dialysis patients, which is roughly 200 and 20,000 would be our total our TAM.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

So free call option is exactly the way to think about it.

Analyst

Great. Thank you

Analyst

so much.

Operator

Thank you. Our next question comes from Prakhar Agrawal from Cantor Fitzgerald.

Analyst

Hi. This is Dal on for Prakhar. I'm to get a better sense of the strategy around expanding exposure uptake in non Medicare channels. And when should we expect to see this from the uptake materialize within these all medical channels? Thank you.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

I'm sorry. I I I couldn't hear the the entire question. Expanding expose into Medicare, did you say?

Analyst

Non Medicare channels. What is the strategy around expanding expose that? I'll take a non Medicare channels.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Yeah. So with non Medicare, you know, that's that's gonna be Medicaid as I said, and commercial are the two main components of non Medicare. And that is forty percent of the patient population. They are seen by nephrologists, are the people that we call on. And one of the important aspects of the way that we do it is we don't tell the nephrologist to discern who's Medicare and not in Medicare.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

We have a closed distribution system that goes through our Deluxe Assist program so that we adjudicate those who are Medicare and those who aren't Medicare. And those who are Medicare, transition into our patient assistance program, and if they qualify, they get free drug. If they are at Medicare, then we work with them through the system if there's prior ops or not to get their prescriptions filled.

Operator

That concludes our question and answer session. Now I'll turn the call over to our host for any additional or closing remarks.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Thank you all for joining us this afternoon, and a special shout out goes to Timardelligs, who I know is listening. Your hard work is invaluable in bringing our essential medicine to our patients. Thanks also to our shareholders. We are building a great company and focused on doing what is right for patients and creating long term value. With that, we can conclude the call.

Mike Raab
Mike Raab
President and Chief Executive Officer at Ardelyx

Thank you, operator.

Operator

That concludes today's meeting. Thank you for joining, and have a pleasant day.

Operator

The host has ended this call. Goodbye.

Executives
    • Caitlin Lowie
      Caitlin Lowie
      Vice President, Corporate Communications and Investor Relations
    • Mike Raab
      Mike Raab
      President and Chief Executive Officer
    • Eric Foster
      Eric Foster
      CCO
    • Justin Renz
      Justin Renz
      Chief Financial & Operations Officer
Analysts
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Key Takeaways

  • Robust Q1 revenue growth: Total revenues rose 61% year-over-year to $74.1 million, driven by strong net product sales of IBSRELA and Exposa, with 2025 guidance for IBSRELA reaffirmed at $240–250 million.
  • IBSRELA momentum: Delivered one of its highest prescription demand quarters ever despite the typical Q1 market contraction, supported by expanded field teams and omnichannel marketing, on track for >$1 billion peak annual sales.
  • Exposa resilience: Achieved 30% revenue growth in Q1 (55% excluding a $3.8 million returns reserve release), maintaining patient access via Ardellix Assist amid Medicare Part D coverage changes and targeting $750 million peak sales from non-Medicare dialysis patients.
  • Financial strength: Reported a Q1 net loss of $41.1 million as R&D ($14.9 million) and SG&A ($83.2 million) investments support commercial execution, secured a $5 million China milestone payment, and ended March with $214 million in cash and investments.
AI Generated. May Contain Errors.
Earnings Conference Call
Ardelyx Q1 2025
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