Q1 2025 Ardelyx Inc Earnings Call

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Unknown Executive: Good day everyone and welcome to the Ardelyx.

Speaker Change: Good day, everyone and welcome to the <unk> first quarter 2025 earnings all participants will be in a listen only mode now I'd like to turn the conference over to Kate Lowrey, Vice President of corporate Communications and Investor Relations Caitlin you may begin.

Caitlin Lowie: All participants will be in And now I'd like to turn the conference over to Caitlin Lowie, Vice President of Corporate Communications and Investor Relations. Caitlin, you may begin. Thank you.

Speaker Change: Thank you good afternoon, and welcome to our first quarter 2025 financial results call.

Caitlin Lowie: Good afternoon, and welcome to our first quarter 2025 financial results call. During this call, we will refer to the press release issued earlier today, which is available on the investor section of the company's website at Ardelyx.com. During this call, we will be making forward-looking statements that are subject to risks and uncertainties. Our actual results may differ significantly from those described. We encourage you to review the risk factors in our most recent quarterly report on Form 10-Q, though it's filed today and can be found on our website at ardelyx.com. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our views change.

Speaker Change: 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 our Dallas Dotcom.

Speaker Change: During this call, we'll be making forward looking statements that are subject to risks and uncertainties. Our actual results may differ significantly from those described.

Speaker Change: Courage 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 our Dallas Dotcom.

Speaker Change: 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.

Michael Raab: Our President and CEO Mike Raab will begin today's call with opening remarks and an overview of the company's performance during the first quarter of 2025.

Mike Raab: Our president and CEO, Mike Raab will begin today's call with opening remarks, and an overview of the company's performance. During the first quarter of 2025 next Chief Commercial officer, Eric Foster It will provide an update on the performance of its sharla and expose that Jeff.

Eric Foster: Next, Chief Commercial Officer Eric Foster will provide an update on the performance of Estrella and Xposa.

Justin Renz: Justin Renz, 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 March 31, 2025, before we open the call to questions.

Mike Raab: Justin Renz, Chief financial and operations Officer will conclude today's prepared remarks with a review of the Companys financial performance. During the first quarter ended March 31 2025.

Mike Raab: Where we open the call for questions with that I'll hand, the call over to Mike.

Michael Raab: With that, I'll hand the call over to Mike. Good afternoon and thank you for joining us today. We're pleased to share an outstanding start to the year at Ardelyx. 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 million. This is noteworthy. 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.

Speaker Change: Good afternoon, and thank you for joining US today, we're pleased to share the outstanding start to the year at our Gallics. We've made excellent progress across all of our priorities and continue to build significant momentum, while navigating a rapidly changing and dynamic marketplace.

Speaker Change: Compared to the same period last year, we generated revenue growth of 61% totaling $74 million. This noteworthy.

Speaker Change: Our teams are building clinical conviction for our therapies and serving more and more patients with these two important therapeutic options.

Speaker Change: We have successfully launched two products during the last three years and we're delivering on our mission.

Michael Raab: 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. Ibsrella's significant long-term potential is 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 Israel for sustained growth and deeper market penetration.

Speaker Change: Now starting with its rolla, it's relevant exciting growth trajectory continues we delivered one of the highest prescription demand quarters to date during the first quarter reinforcing our confidence in a trailer as a differentiated important and valuable treatment for patients.

Speaker Change: It's relative significant long term potential is supported by a large and growing market and continued unmet need among patients remain inadequately served by Secretagogue.

Speaker Change: Our commercial team is effectively driving prescriber adoption by building clinical conviction among high value targets, while our expanded feel access management team is enhancing patient access and pull through.

Speaker Change: Together. These efforts are positioning withdrawal for sustained growth and deeper market penetration.

Michael Raab: We are on track to meet our 2025 guidance of $240 to $250 million in net sales, and we have a clear path to achieving peak annual net sales revenue of over a billion dollars.

Speaker Change: We are on track to meet our 2025 guidance of $240 million to $250 million in net sales and we have a clear path to achieving peak annual net sales revenue of over $1 billion.

Michael Raab: Now turning to Xposa. During the first quarter, EXFOSA grew by 30% compared to last year, not including the one-time gross net adjustments for return reserve release. This performance reflects the clear unmet need that exists for patients, the growing role for Xposa is playing in helping patients achieve and maintain target phosphorus levels, and the remarkable momentum our team built in 2024.

Speaker Change: Now turning to expose them.

Speaker Change: During the first quarter exploring exposure grew by 30% compared to last year, not including the onetime gross to net adjustments for return reserve release.

Speaker Change: This performance reflects the clear unmet need that exists for patients the growing role for exposed is playing in helping patients achieve and maintain target phosphorus levels and the remarkable momentum our team built in 2024.

Michael Raab: 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 EXPOSE's clinical value.

Speaker Change: It is important to recognize that with a 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 nephrologist and patients.

Speaker Change: Our decisions around expose remains firmly grounded in our commitment to patient care.

Speaker Change: Amid this uncertainty we are 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 exposes clinical value.

Michael Raab: 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, Ardelyx continues to execute with resolve, discipline, and agility, and we're making progress in our strategic priority. driving strong commercial execution for Xtrella, navigating the access complexities and generating important commercial momentum with Xposa, building a pipeline to unlock long-term growth and continually delivering on a strong financial performance.

Speaker Change: 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.

Speaker Change: Across the board, our Dallas continues to execute with resolve discipline and agility and we're making progress on our strategic priorities driving strong commercial execution for <unk> rollout navigating.

Speaker Change: Navigating the access complexities and generating important commercial momentum with exposure.

<unk> a pipeline to unlock long term growth and continually delivering on our strong proof that financial performance.

Michael Raab: Our high-performing team, differentiated products, and commitment to patient-centric innovation position us to lead and grow in a rapidly evolving healthcare environment, and we remain steadfast as we build long-term value for our shareholders.

Speaker Change: 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.

Eric Foster: Thank you for your continued support and confidence in Ardelyx, and I will now hand it over to Eric to share his perspectives on our commercial performance during the first quarter. Eric. Thanks, Mike, and it's great to be with you all again. Q1 was another great quarter for both products. Ipsirela and Exposa delivered meaningful year-over-year growth. Consistent with prior Q1s, we saw the IBSC 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 Ipsirela 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.

Speaker Change: Thank you for your continued support and confidence in <unk> and I will now hand, it over to Eric to share his perspectives on our commercial performance during the first quarter Eric.

Eric: Thanks, Mike it's great to be with you. All again Q1 was another great quarter for both products. It is thrilling expose it delivered meaningful year over year growth consistent with prior Q1s. We saw the Ibs C market contract and as you know the Hypophosphatasia market was impacted by the elimination of Medicare part D coverage for phosphate.

Eric: <unk> therapies. Despite these headwinds we saw strong prescription demand Forbes trailer and demonstrated that both Medicare and non Medicare patients are able to access exposure as we continue to meet the unmet need in the market. The team is focused on execution and building on our Q1 momentum as we enter an important second quarter in a position of <unk>.

Eric Foster: The team is focused on execution and building on our Q1 momentum as we enter an important second quarter in a position of strength.

Eric Foster: Let me start with Ipsirela. Ipsirela 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 refilled prescriptions. As I mentioned before, the IBSC market historically contracts during the first quarter and we saw clear evidence of it in Q1, especially early on. Despite that contraction, Ipsrela 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 Ipsrela and the value this medicine can bring patients.

Eric: Great.

Eric: Let me start with Israel, Israel grew 57% over last year. This is incredible growth as we enter our third full year post approval.

Eric: Saw increases across key demand indicators, including new and total riders and new and refill prescriptions.

Eric: 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 thriller demonstrated strong prescription demand consistent with Q4 and exited the quarter with very strong momentum.

Eric: This is further evidence of the confidence that Hcp's have Ann Taylor and the value of 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 C.

Eric Foster: As we look ahead, we remain focused on making progress against our strategic imperatives to drive growth and help more patients with IBSC. which include raising awareness and favorable perception of ipsarella, expanding target HCP's view of potential ipsarella patients. positioning Ibzarrella as the first action for appropriate patients who are not getting adequate relief or are not satisfied on a Secretigoc, and encouraging HCPs to send prescriptions to one of our specialty pharmacy partners or Ardelyx's. 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: Which include raising awareness and favorable perception of withdrawal expanding target hcp's view of potential external of patients positioning Israel as the first action for appropriate patients who are not getting adequate relief or are not satisfied on a secretagogue.

Eric: An encouraging hcp's to send prescriptions to one of our specialty pharmacy partners or our Delek US assist these strategic imperatives are allowing us to create opportunities across all aspects of the physician and patient journey to improve the HCP perception drive consideration and support prescription pull through our expanded field based teams and our army.

Eric Foster: Our expanded field-based teams and our omni-channel marketing initiatives are focused on these areas, and we continue to see improvement. Ipseril is an important treatment option for patients with IBSC, and we remain confident in our path to greater than $1 billion peak-year net sales.

Eric: The channel marketing initiatives are focused on these areas and we continue to see improvement in Australia is an important treatment option for patients with Ibs C and we remain confident in our path to greater than $1 billion peak year net sales revenue.

Eric Foster: Now on to Xposa. Xposa had another very strong performance, delivering 30% revenue growth compared to last year when you exclude the returns reserve release. This demonstrates that Xposa continues to be an important medicine to help patients achieve and maintain target phosphorus levels, despite the turmoil and disruption in the market. It also gives us confidence that Xposa's strategy is working. Most importantly, the operational plan has allowed patient access to continue. We're driving a clear message to healthcare providers that is resonating. Prescribe as you always have, based on the patient need, and we will support access through our patient services program.

Eric: Now onto exposure.

Eric: Expose it had another very strong performance delivering 30% revenue growth compared to last year. When you exclude the returns reserve release. This demonstrates that exposure continues to be an important medicine to help patients achieve and maintain target phosphorus levels. Despite the turmoil and disruption in the market. It also gives us confidence that exposure.

Eric: Strategy is working and most importantly, the operational plan has allowed patient access to continue we are driving a clear message to health care providers that is resonating prescribed as you always have based on the patient need and we will support access through our patient services programs.

Eric Foster: As we look at X-POSE's performance during the quarter, there were several positive indicators that gives us confidence as we move forward. 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 exposed prescriptions, and that they continue to believe that at least 30% of the patients are candidates for exposure. To maintain the momentum that the team has established, we must remain focused on the factors that influence our ability to drive development.

Eric: As we look at exposes performance during the quarter. There were several positive indicators that gives us confidence as we move forward, we saw new riders prescribing during the quarter as well as both new and refill prescriptions continue.

Eric: In addition, our internal market research indicates that the vast majority of survey nephrologists recognize they are the decision makers for exposed to prescriptions and that they continue to believe that at least 30% of the patients are candidates for exposure.

Eric: To maintain the momentum that the team is established we must remain focused on the factors that influence our ability to drive demand.

Eric Foster: There is a high unmet need among dialysis patients for tools to achieve and maintain target phosphorus levels. Physician satisfaction with Xposa remains high. Access to Xposa has been protected. And lastly, we have a strong share of voice in the market. The commercial team and all of Team Ardelyx 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.

Eric: There is a high unmet need among dialysis patients for tools to achieve and maintain target phosphorus levels <unk>.

Eric: <unk> satisfaction with exposure remains high access to exposed to has been protected and lastly, we have a strong share of voice in the market the.

Speaker Change: The commercial team and all of team our Dallas 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.

Eric Foster: We are focused on executing our plan and maintaining the growth momentum for the remainder of the year.

Speaker Change: We are focused on executing our plan and maintaining the growth momentum for the remainder of the year I will now turn it over to Justin Justin Thank.

Justin Renz: I will now turn it over to Justin. Justin. Thank you, Eric.

Justin Renz: Thank you Eric.

Justin Renz: 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 cast position to continue building the business. We had total revenues of $74.1 million in the first quarter of 2025, an increase of 61% compared to the $46 million 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 2025 compared to the same period of 2024. During the first quarter of 2025, we recorded Ibsrela net sales revenue of $44.4 million, an increase of 57% over the same period of last year.

Justin Renz: 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 our strong cash position to continue building the business.

Justin Renz: We had total revenues of $74 1 million.

Justin Renz: In the first quarter of 2025, an increase of 61% compared to the $46 million, we reported last year.

Justin Renz: 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 2025 compared to the same period of 2024.

Justin Renz: During the first quarter of 2025, we recorded <unk> net sales revenue of $44 4 million.

Justin Renz: An increase of 57% over the same period of last year.

Justin Renz: Our growth was driven by strong patient demand and the continued focus on commercial execution from clinical consideration to prescription pull through. 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 net deduction for ABSRELA for the quarter was 34.8 percent, and as we've experienced, we expect this to improve throughout the course of the year. We expect continued growth for ABSARELLA, and we reaffirm our 2025 guidance of $240 to $250 million in net product sales revenue.

Justin Renz: Our growth was driven by strong patient demand and the continued focus on commercial execution from clinical consideration to prescription pull through.

Justin Renz: As we have consistently shared with you in the past our net sales were impacted during the quarter due to normal Q1 market dynamics.

Justin Renz: In line with our expectations the gross net deduction for <unk> for the quarter was 34, 8% and as we've experienced we expect this to improve throughout the course of the year.

Justin Renz: We expect continued growth for <unk>, we reaffirm our 2025 guidance of $240 million to $250 million and net product sales revenue.

Justin Renz: We also recorded $23.4 million in net product sales revenue of Exposa in the first quarter of 2025, an increase of approximately 55% compared to $15.2 million in the first quarter of last year. As you saw in our press release, Exposed Net Sales Revenue includes a one-time $3.8 million release of our Returns Reserve. Excluding this returns reserve release, our year-over-year growth for EXFOSA 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.

Justin Renz: We also recorded $23 $4 million.

Justin Renz: Net product sales revenue of exposure in the first quarter of 2025, an increase of approximately 55% compared to $15 2 million in the first quarter of last year.

Justin Renz: As you saw in our press release expose the net sales revenue includes a one time $3 $8 million release of our returns reserve.

Justin Renz: Excluding this returns reserve release, our year over year growth for <unk> was 30%.

Justin Renz: Our returns reserve considers our returns policy and the passage of time since launch when coupled with zero product returns to date and our open return window and the very low number of bottles and our downstream distribution channel. It was clear that our returns reserve is unnecessary.

Justin Renz: As a result, our gross net deduction for explosive during the first quarter was approximately 18 percent. Excluding the impact of this release, it was approximately 32%.

Justin Renz: As a result, our gross net deduction for exposure during the first quarter was approximately 18%.

Justin Renz: Excluding the impact of this release it was approximately 32%.

Justin Renz: In addition to product revenue, we earned a $5 million milestone from our partner in China, following the approval of Cannabinoid for hyperphosphatemia. We received payment from Fosun Pharma in a We also recorded $1 million in non-cash royalty revenue during the first quarter of 2025, compared to $370,000 in the same period last year.

Justin Renz: In addition to product revenue, we earned a $5 million milestone from our partner in China. Following the approval of cannabinoid for Hypophosphatasia.

Justin Renz: We receive payment from Fosun pharma in April.

Justin Renz: We also recorded $1 million and noncash royalty revenue during the first quarter of 2025 compared to 370000 in the same period last year.

Justin Renz: Research and development expenses were $14.9 million for the first quarter of 2025, compared to $10.6 million for the same quarter of the prior year. The increase in R&D expenses reflects increased engagement with the scientific and medical community.

Justin Renz: Research and development expenses were $14 9 million for.

Justin Renz: For the first quarter of 2025 compared to $10 6 million for the same quarter of the prior year.

Justin Renz: The increase in R&D expenses reflects increased engagement with the scientific and medical communities.

Justin Renz: selling general and administrative expenses for the quarter were in line with our expectations at 83.2 million dollars compared to 53 million that were reported for the same period in the prior year. The increase was related to commercial activities for Absarella and Xposa, including the Absarella Salesforce expansion, as well as growth of the overall corporate infrastructure to support our strategy. In the first quarter of 2025, we also had $12.1 million in non-cash stock compensation expense and $2.1 million in non-cash interest We had a net loss of approximately $41.1 million, or $0.17 per share in the first quarter, compared to a net loss of $26.5 million, or $0.11 per share, in the same period of last year.

Justin Renz: Selling general and administrative expenses for the quarter were in line with our expectations at $83 2 million.

Justin Renz: Compared to $53 million that we reported for the same period the prior year.

Justin Renz: The increase was related to commercial activities for <unk>, including the <unk> sales force expansion as well as growth of the overall corporate infrastructure to support our strategy.

Justin Renz: In the first quarter 2025, we also had $12 1 million in noncash stock compensation expense and $2 1 million in noncash interest expense.

We had a net loss of approximately $41 1 million or <unk> 17 per share in the first quarter compared to a net loss of $26 5 million or <unk> 11 per share the same period of last year.

Justin Renz: As of March 31st, 2025, our total cash equivalents and short-term investments was $214 million.

Justin Renz: As of March 31, 2025, our total cash cash equivalents and short term investments was $214 million.

Justin Renz: The first quarter demonstrated strong demand for Umbrella and clear evidence the exposure strategy is working. We remain confident that there's a significant opportunity for both of our medicines that we're on track to achieving our peak sales expectations. more than $1 billion for ABSRELA and $750 million for EXPOSA. We are building a great company and focused on delivering shareholder value.

Justin Renz: The first quarter demonstrated strong demand from thriller and clear evidence to expose the strategy is working.

Justin Renz: We remain confident that there is a significant opportunity for both of our medicines that we are on track to achieving our peak sales expectations.

Justin Renz: More than $1 billion, Forbes, rella and $750 million per exposure.

Justin Renz: We are building a great company and focused on delivering shareholder value.

Michael Raab: With that, I'll hand it back to Mike. Thanks, Justin. It's 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.

Mike Raab: With that I'll hand, it back to Mike.

Mike Raab: Thanks, Justin.

Speaker Change: 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.

Michael Raab: I will now open the call to questions.

Unknown Executive: Operator. If you'd like to ask a question, please press star 1 on your phone now, and you'll be placed into the queue in the order. Please be prepared to ask your questions. Once again, press star 1.

Speaker Change: If you'd like to ask a question. Please press star one on your phone now you'll be placed into the queue of the order received.

Speaker Change: Please be prepared to ask you question what prompted once again press star one for a question.

Louise Chen: Our first question comes from Louise Chen of Scotia. Congratulations on all the progress this quarter. I wanted to ask you two questions here.

Speaker Change: And our first question comes from Louise Chen of Scotiabank.

Speaker Change: Congratulations on all the progress this quarter I wanted to ask you two questions here first for the Ibs D market do you expect this to improve as you go through second quarter and beyond.

Louise Chen: First, for the IVSD 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?

Speaker Change: Versus the contraction that you've historically seen 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 looks like going forward. Thank you.

Justin Renz: And then secondly, could you explain in more detail the return reserve and how that impacts the sales and what that could look like?

Justin Renz: Sure, let me ask Justin to start with the second question first. Thanks, Louise. Yes, so as part of our gross net, we have a returns reserve, and our returns reserve, you know, again, as 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, there was no longer appropriate to carry this reserve on our balance sheet.

Speaker Change: Sure Let me ask just to start with the second question first thanks.

Speaker Change: Thanks, Louise yes, so as part of our gross to net we haven't returns reserve in our returns reserve.

Speaker Change: Ken 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 that are downstream distribution. There was no longer appropriate to carry this reserve on our balance sheet. So we will no longer be doing this prospectively and this of course would have modest improvement to our gross to net.

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

Speaker Change: Respectively.

Eric Foster: Thank you. Yeah, thanks, Louise, for the question. With regard to the IBSC market improving as we go through the year, the short answer to that is yes. You know, the IBSC market in the first quarter, we know, traditionally contracts, and that's exactly what we saw early on in Q1. But we continue to remain very optimistic, given that we had our highest prescription demand quarter in Q1. We were able to, I'm sorry, in Q4, and we were able to see that consistent in Q1. 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.

Speaker Change: Sure.

Speaker Change: Yes, 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.

Speaker Change: <unk> market in the first quarter, we know traditionally contracts and Thats exactly what we saw early on in Q1, but we continue to remain very optimistic given that we had our highest prescription demand quarter. In Q1, we were able to I'm sorry in Q4, and we were able to see that that consistent.

Speaker Change: Q1, and certainly were 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 will continue to see that improve.

Eric Foster: Thank you. Thanks, Louise.

Speaker Change: Thank you.

Louise Chen: Thanks Louise.

Ryan Deschner: Our next question comes from Ryan Deschner of Raymond. I think to the question, I just wanted to ask a little bit more about the One-Q contraction. What are you attributing to the level of overall contraction in One-Q? Is it looking different from prior One-Q situations?

Speaker Change: Our next question comes from Ryan <unk> of Raymond James.

Ryan: Hi, Thanks for the question.

Speaker Change: Just wanted to ask a little bit more about the <unk> contraction what are you attributing some of that level of overall contraction in <unk>.

Speaker Change: Looking different from prior <unk> situations, and then I have a follow up thank you.

Justin Renz: Sure, thanks for the question, Ryan. I think just for some context is, the market is consistently contracted, I think in their first two years on the market, given 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. I think if you compare us to others within that market basket, I'm pleased with the performance that we saw out of Adrela.

Speaker Change: Sure. Thanks for the question Ryan I think just for some context as the market has consistently contracted I think in their first two years on the market given 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 I think if you compare.

Speaker Change: Fair us to others within that market basket I'm pleased with the performance that we saw out of the draw Eric 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.

Eric Foster: Eric? Yeah, I would just add, as we've continued 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. Got it.

Minute ago, we expect that to continue to grow in 2025 for the rest of the year.

Speaker Change: Got it and then.

Ryan Deschner: And then what What are you targeting for your long-term growth to net, if you're disclosing a level for Xposa at SteadyState?

Speaker Change: What's.

Speaker Change: What are you targeting for your long term gross to net if you're if you're disclosing a level for exposure at steady state and also.

Justin Renz: And also, do you have any color or a status update on the launch in China now that it's? Yeah, 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.

Speaker Change: Do you have any color or a status update on.

Speaker Change: The launching of in China now that it's approved.

Speaker Change: Yes, so China first.

Speaker Change: Once we get more perspective from our partner we can share that.

Speaker Change: So probably not much to talk about there and just if you could address the gross net.

Justin Renz: And Justin, if you could address the gross net. 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 would say, you know, we had 32%, irrespective of the gross to net change we made for the returns reserve in Q1.

Speaker Change: Sure. It's still early because we are in the new treatment paradigm. If you will to coverage mix where is changing in 2025 compared to 2024.

Speaker Change: So we're not really fully there yet I would say.

Speaker Change: We had 32% irrespective of the gross to net change we made for the returns reserve in Q1.

Ryan Deschner: I think it's fair to say, Ryan, and Justin, correct me if I'm wrong, is that generally our guidance for both the 30% plus or minus five is likely to hold true continually going forward. That's a great place to start modeling. It's very helpful. Thank you very much. Thanks, Ryan.

Speaker Change: I think it's fair to say Ryan and it doesn't correct me if I'm wrong is that generally our guidance for both the 30% plus or minus five is likely to hold true continually going forward.

Speaker Change: Great place to start modeling.

Speaker Change: That's very helpful. Thank you very much.

Ryan: Thanks Ryan.

Speaker Change: Yeah.

Dennis Dang: Our next question comes from Dennis Dang of Jeff. Hi, thanks for taking our questions. Two for me. On Ipsarela, I mean, how do you guys reconcile what's being reported through IMS and the 44 million? Based on scripts and I think through some reasonable assumptions, I think people would expect 44. quite a surprise to us.

Speaker Change: Our next question comes from Dennis Yang of Jefferies.

Dennis Yang: Hi, Thanks for taking my questions two for me.

Speaker Change: <unk> Sirona.

Speaker Change: How do you guys reconcile what's being reported through IMS and the $44 million in revenue figures reported because based on scripts and I think through some reasonable assumptions I think people were expecting around $52 million of the $44 million was quite a surprise to us and then.

Dennis Dang: And then question number two is on the CMS litigation on EXPOSA. When do you expect the decision on the appeal?

Speaker Change: Question number two is on the CMS litigation on exposure.

Speaker Change: When do you expect the decision on the appeal and I guess hypothetically if there were a positive decision in exposure was.

Michael Raab: And I guess hypothetically, if there were a positive if post-FOMA explosive was given back Part D, how quickly can things be restored back to 2024 levels in terms of the underlying structural logistics at the DOC? Thank you.

Speaker Change: Given back part D.

Speaker Change: How quickly can things be restored back to 2024 levels in terms of the underlying.

Speaker Change: <unk> logistics at the Ddos. Thank you.

Michael Raab: Well, I'll address the last question first. 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.

Speaker Change: Well I'll address the last question first.

Speaker Change: Probably not healthy to get into hypotheticals.

Speaker Change: Just given everything that we're seeing going on in Washington.

Speaker Change: All of the briefs that need to be filed or filed and were just waiting for the courts to set a date.

Speaker Change: And we will navigate through that and as we learn more we will certainly.

Speaker Change: Bring it to your attention I'll ask.

Michael Raab: 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 in 240 to 250. And the perturbations in the first quarter are part of the reason that we encourage you to look at it as such.

Speaker Change: 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 as you need to hold us to account for the guidance that we gave you and as you heard all to say we are confident in the $2 40 to $2 50.

Speaker Change: And the perturbations in the first quarter are part of the reason that we encourage you to look at it as such.

Eric Foster: Eric, any thoughts? Yeah, thanks, Dennis. Good question. You know, we think about demand, we were very pleased with what we saw in Q1. As I noted, consistent with what we saw in Q4, which was our highest demand quarter to date. Certainly, when you look at net sales, it can be impacted by market dynamics. When we think about Q1, we typically see things like the IVSC 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.

Dennis Yang: Eric any thoughts yes, thanks Dennis.

Dennis Yang: Good question as we think about demand we were very pleased with what we saw in Q1 as I noted consistent with what we saw in Q4, which was our highest demand quarter to date certainly when you look at net sales it can be impacted by market dynamics. When we think about Q1, we typically typically see things like the Ibs C market contract, we've got prior authorization renewals insurance coverage.

Dennis Yang: Resets wholesaler buying patterns and higher patient co pays and all of 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 Q2, and then Dennis I think what's important about that strong momentum Q1 was our second.

Michael Raab: We also see that normalizes. And we feel like we really ended the quarter with strong momentum and certainly feel very confident as we go into Q2. And Dennis, I think what's important about that strong momentum, Q1 was our second highest generation of demand to date, right? So what Eric just described certainly 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 IVSC market basket.

Dennis Yang: Highest generation of demand to date.

Dennis Yang: So what Eric just described certainly as I am sure from the perspective that youre, 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 of the way other <unk>.

Dennis Yang: Products were in the Ibs C market basket.

Unknown Executive: Got it. Thanks.

Dennis Yang: Got it thanks.

Unknown Executive: Thanks, Senator.

Dennis Yang: Thanks Dennis.

Laura Chico: Our next question comes from Laura Chico from Web Bush. I thank you very much for taking our question.

Speaker Change: Our next question comes from Laura Chico from Wedbush Securities.

Speaker Change: Thank you very much for taking our question. This is Dylan on for Laura Chico.

Unknown Executive: This is Dylan on for Laura Chico. I was wondering what metrics are you monitoring to assess the impact of the newly expanded Israel upscaled forest? And what gives you confidence that you're on a trajectory to meet the peak revenue? Sure. 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.

Speaker Change: Wondering what metrics are you monitoring to assess the impact of the newly expanded Israel Our field force.

Speaker Change: And what gives you confidence that you're on a trajectory to meet that.

Speaker Change: Revenue expectation.

Speaker Change: Sure.

Speaker Change: First of all as 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.

Speaker Change: It gives us that confidence.

Dolan: Just said Dolan.

Dolan: This was our second largest quarter of demand generation that we've seen since launch that is part of the confidence I get it.

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

Dolan: In the midst of that market contraction as I said, we contracted less than the others that gives me confidence.

Dolan: Accretable unmet need that's out there.

Dolan: And the better access that we have with a larger sales organization.

Eric: I think all comes together Eric other thoughts.

Eric Foster: Eric, other thoughts? Yeah, you know, for me, I mean, what I think about is really three things. Are we seeing an increase in activity? Are we seeing an increase in riders, whether it be total riders or new riders? And then are we seeing that lead to new and refilled prescriptions? 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, Q1 is the second highest demand prescription demand quarter to date.

Eric: For me I mean, what I think about it is really three things are we seeing an increase in activity are we seeing an increase in riders whether we total riders are new riders and then are we seeing that lead to new and refill prescriptions 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.

Speaker Change: See an increase in the new in the refill prescriptions as Mike mentioned Q1 was 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.

Eric Foster: 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 our highest demand quarter in Q4. So those are some of the basic metrics that we look at to make sure that we're getting the activity that we need. It'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 need this treatment for their IBSC.

Speaker Change: Looked really good coming off of what Mike said was our highest demand quarter. In Q4. So those are some of the basic metrics that we look at to make sure that we're getting the activity that we need is 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 need this treatment for their Ibs C.

Speaker Change: Yeah.

Unknown Executive: Thank you.

Speaker Change: Thank you.

Speaker Change: Excellent.

Speaker Change: Yeah.

Joseph Tomei: Our next question comes from Joseph Tomei of TD Cal. Hi there, good afternoon. Thank you for taking our questions.

Speaker Change: Our next question comes from Joseph <unk> of TD Cowen.

Speaker Change: Hi, there good afternoon, and thank you for taking my questions.

Joseph Tomei: Maybe the first one, can you comment a little bit on the demand specifically in the commercial channel, and how that changed from Q4 to Q1 for Xposa, just to kind of get an idea of growth in that segment?

Speaker Change: The first one can you comment a little bit on the demand specifically in the commercial channel.

Speaker Change: And how that changed from Q4 to Q1 for exposed that just to kind of get an idea of growth.

Justin Renz: And then a question on the financials. When we look at the R&D and SG&A spend for this quarter, should we use this as sort of the new base going forward? And maybe relatedly, how much wiggle room do you have in the spend for Xposa to make sure, you know, that business stays profitable going forward, depending on what you're looking at?

Speaker Change: In that segment and then a question on the financials. When we look at the R&D and SG&A spend for this quarter should we use this as sort of a new base.

Joe: Going forward and maybe Relatedly, how much wiggle room do you have in the spend for expose us to make sure you know that business stays profitable going forward, depending on what we see this year. Thank you sure. Let me ask just him to address the second part of your question first right. So thanks Joe.

Justin Renz: Sure, let me ask Justin to address the second part of your question first. Great. So thanks, Joe. Yes, we had modest increase in our SG&A in Q1 compared to Q4. So, we might have seen an increase from 76 to 83, and we expect that will rise over the course of 2025 to around 90 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.

Joe: Yes, we had modest increase in our SG&A in Q1 compared to Q4. So you might have seen increased from 76 to 83, and we expect that.

Joe: That will rise over the course of 2025 to around $90 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 expose that in all of the patient access and everything else is available through our either our patient assistance program, our field managers and everything in between so we.

Eric Foster: So, we feel like that is in good shape and some modest increase over the next few quarters. From an R&D perspective, we were approximately 15, 1.5 million 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 million, and we're in good shape for a financial position. And Joe, just to clarify, your question is more than just commercial. It's the non-Medicare segment, right? Correct.

Joe: We feel like that is in good shape and some modest increase over the next few quarters from an R&D perspective, we were approximately 15, one 5 million 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 million and we're in good shape for our financial position.

Joe: And Joe just to clarify your question is more than just commercial it's the non Medicare segment right.

Joe: Correct, yes, Okay, yes, Eric if you could address that yes. Thanks, Joe what we saw in Q1 was we saw that Medicare had about a weighted average of around 13% of the total payer mix. We think about that we saw that it was primarily in the first few weeks. Unfortunately these patients had the benefit of a one time transitional fill through CMS and we saw it.

Eric Foster: Okay, yeah, Eric, if you could address that. Yeah, thanks, Joe. You know, what we saw in Q1 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. 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 rest of the mix was really predominantly through the commercial and the Medicaid side, which, as you know, is the non-Medicare mix.

Joe: That take place.

Joe: And like I said it was primarily in the first few weeks, but what we saw as the quarter continued to move was the rest of the mix was really predominantly through the commercial and the Medicaid side, which as you know that 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 Q1, and that's giving US continued confidence as we move forward.

Eric Foster: So we were able to see good momentum there as the quarter continued and feel really good about where things ended at the end of Q1.

Eric Foster: And that's given us continued confidence as we move forward and really focusing on being able to allow all patients, regardless of whether it's Medicare or non-Medicare, be able to have access moving forward.

Joe: It really focusing on being able to to allow all patients regardless of whether it's Medicare and non Medicare be able to have access moving forward.

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

Joe: I guess just wanted to follow up to the financial question is not that we're necessarily looking for wiggle room, I think we have incredible confidence in the trajectory that we're on with exposure and the way that we've approached the market. So it's not that we're looking for wiggle room I think we're on track with what we anticipated which is why we reaffirmed the 750 million peak.

Joe: And 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.

Unknown Executive: Great.

Unknown Executive: Thank you very much. Very helpful.

Speaker Change: Great. Thank you very much very helpful. Thanks.

Speaker Change: Thanks, Joe.

Roanna Ruiz: Our next question comes from Roanna Ruiz of Leran Hey, afternoon, everyone. Follow up about Exposa. I was curious, do you have any updates on the how the patient assistance program is operating right now and some of your plans to keep going forward into 2Q and 3Q?

Speaker Change: Our next question comes from Brian <unk> of Leerink partners.

Brian: Hey afternoon, everyone.

Brian: Follow up about expose Oh I was curious.

Brian: Do you have any updates on the how the patient assistance program is operating right now in some of your plans to keep going forward into <unk> and <unk> and the second part of it is I was also curious off the last question thinking about commercial in non Medicare.

Eric Foster: And the second part of it is, I was also curious, 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?

Brian: Are those trends, possibly tracking into exiting <unk> and thinking about two Q3 Q.

Eric Foster: Sure, let me ask Eric to address this for you. Yeah, so thank you. So with regards to PAP, or the Patient Assistance Program, we're very pleased with how the Ardelyx 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 and Q4, they were able to continue accessing EXPOSA in Q1 through our Patient Assistance Program. 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 first quarter.

Brian: Sure, Let me ask Eric to address those for you.

Eric: Yes. So thank you so with regards to path, where the patient assistance program, we're very pleased with how the.

Speaker Change: <unk> assists us being able to help patients in need, particularly those Medicare patients we saw patients that were on.

Speaker Change: Exposure for Medicare part D. In Q4, they were able to continue accessing accessing gets exposed to end Q1 through our patient assistance program. 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 first quarter.

Eric Foster: 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 Q2, Q3, Q4 decision for us. We're continuing to move forward so that all patients, regardless of Medicare and non-Medicare have coverage for EXPOSA.

Speaker Change: We're 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 Q2 Q3 Q4 decision for US we're continuing to move forward, so that all patients regardless of Medicare and non Medicare have coverage.

Speaker Change: Four four exposure with regards to the commercial business again very pleased with what we're seeing there on the non Medicare segments as I noted we saw.

Eric Foster: 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 vast majority of the Medicare transitional bills 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 the VA business that we saw really increase in that latter half of Q1. And that's what's given us confidence as we move into the remainder of the year.

Speaker Change: Really the vast majority of the Medicare transitional sales within the first few weeks, but really that dissipated and we really aren't factoring that into.

Speaker Change: 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 the VA business that we saw really increase in that latter half of Q1, and thats whats given us confidence as we move into the remainder of the year.

Michael Raab: 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 going to 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.

Speaker Change: Just a couple of comments on that Ryan is if you the confidence that we have coming from January where everything everyone was wondering how this was going to work.

Speaker Change: And then as it.

Speaker Change: Progress through to March 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 does some of the binders that they've been on for a long time arent available.

Speaker Change: Ultimately us having to work in choosing to work with an approach so that the center of their decision making.

Speaker Change: As they were before in the midst of all this turmoil I am very pleased the way that the team is actually help them navigate through it and the strength of our dogs assist team and the program. There in particular is paying dividends.

Unknown Executive: And the strength of the R-Delix assist team and the program there in particular is paying dividends. Got it. Thanks for the help. Thank you.

Speaker Change: Got it thanks for the help.

Speaker Change: Thank you.

Julian Harrison: Our next question comes from Julian Harrison from BTI. Hi, thank you for taking my questions. When you look at high-volume IVF-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, 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. Yeah, just one quick comment.

Speaker Change: Our next question comes from Julian Harrison from BTG.

Julian Harrison: Hi, Thank you for taking my questions.

Julian Harrison: When you look at high volume Ibs C. Prescribers are you're left with the impression that they generally know who the best candidates are for his perella.

Julian Harrison: And I ask this because I 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 I'm also just wondering how you expect maybe the gap to narrow there going forward.

Speaker Change: Yeah, just one quick comment I'll ask Eric to address it a disconnect between prescriber and patient is probably a pretty traditional phenomena across many therapeutic areas.

Michael Raab: 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. 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 want to 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, kind of 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 patient's thing.

Speaker Change: And to me at least with what I see the significant untapped potential that's out there is remarkable don't forget that all of our clinical work with first line therapy.

Speaker Change: And the fact that a new mechanism like this given payer dynamics as it forces you into making the decision we did because we didnt want to negotiate with payers that we would be second line is what gets us to where we are at the dissatisfaction when you talk to patients with what they have with GC C agonist kind of hard when a physician doesn't yet understand this new mechanism and what it does it.

Speaker Change: We can provide that they may see a disconnect between those patients, but that's the work and why we expanded the field and the yields that we're seeing from that effort.

Eric Foster: But that's the work and why we expanded the field and the yields that we're seeing from that effort.

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

Speaker Change: Yes, I would just add there certainly is plenty of opportunity out there.

Speaker Change: You mentioned the disconnect and we're very much aware of that and really take it very seriously and our responsibility to help.

Speaker Change: Connect the physician and the patient.

Speaker Change: Patients physicians they do recognize who these patients are it's actually when we talk to physicians. It's patients that are diagnosed with Ibs C. Theyre currently honest accretive on therapy and yet they're not satisfied they are not getting that relief for us. It's really trying to get the physician to act with urgency and then they've been writing secreted guys now for a decade.

Eric Foster: You know, they've been writing secretive guides 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 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. And 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 that we're seeing in Torella being used really second line for those.

Speaker Change: So we need to continue to try to break these habits.

Speaker Change: Getting into recognize the appropriate patient I think 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.

Speaker Change: Is not satisfied or theyre, not getting adequate relief and we know thats quite a few patients because we know about a third of those patients out there.

Speaker Change: Our satisfied so that leaves quite a few patients out there that are currently diagnosed on a treatment not satisfied and getting adequate relief.

Speaker Change: We're seeing intra Libyan use really second line for those patients.

Speaker Change: Yeah.

Aidan Huzinov: Our next question comes from Aidan Huzinov from Latin America.

Speaker Change: Our next question comes from agents using off from Lindbergh.

Aidan Huzinov: Hi, good afternoon, everyone. Congratulations with this quarter. I've got a couple of questions. So, appreciate Exposure's long-term guidance confirmation $750 million.

Speaker Change: Hi, good afternoon, everyone. Congratulations for this quarter.

Speaker Change: I've got a couple of questions. So efficient explore this a long term guide is confirmation of several hundred system and then so could you provide some dynamic of sort of how you plan to get there are sort of ramp up curve and if possible any 2025 sort of so so.

Michael Raab: So, could you provide some dynamic of sort of how you plan to get there, sort of ramp up curve, and if possible, any 2025 sort of soft guidance kind of hints? And does the long-term guidance not include Medicare? And in case you'll be able to sort of include Medicare, further on, how would that actually affect the upside for Exposure sales? 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 60% of the dialysis population is Medicare. Non-Medicare is primarily Medicaid and commercial.

Speaker Change: Guidance kind of Haynes.

Speaker Change: And does the long term guidance not include Medicare and in case, you will be able to sort of include Medicare.

Speaker Change: Are they on wood, how will that actually affect the upside for explore the sales peak sales.

Speaker Change: 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 60% of.

Speaker Change: The dialysis population is Medicare non Medicare is primarily Medicaid and commercial and the comments from both with 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 confidently.

Michael Raab: And the comments from 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 incompetently get to $750 million.

Speaker Change: Get to $750 million as we've said last year as we were entering this year and reaffirmed in my opening comments, it's too early for us to be giving you guidance as to what 2025 is going to look like we are once we have confidence and I believe it will happen.

Michael Raab: As we said last year, as we were entering this year and reaffirmed in my opening comments, it's too early for us to be giving you guidance as to what 2025 is going to 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. Thank you. I appreciate that.

Speaker Change: In the not too distant future, we will provide you some perspective as to what we think 2025.

Speaker Change: Turned out to be.

Speaker Change: Thank you I appreciate that and one follow on question.

Michael Raab: One follow-on question. How much of the decision-making by nephrologists may affect the insurance coverage? And have you seen any pushback from payers so far for Exfolio, given your sort of ongoing negotiations with... Sure, well. Paired 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? Yeah, I would just say, you know, right now we're really not seeing any pushback on the commercial side. And it's good to see that the nephrologist still has the ownership and really is at the decision, the center of the decision making.

Speaker Change: It's.

Speaker Change: How much of the decision, making by Nephrologist may affect the insurance coverage and have you have you seen any pushback from payers so far for <unk>, given your sort of ongoing negotiations with CMS.

Speaker Change: Sure.

Speaker Change: Parents, CMS, probably not correlated two very separate things.

Speaker Change: The Nephrologist and <unk> are extremely important as it relates to getting prior authorizations through.

Eric: Eric other thoughts.

Speaker Change: Yeah, I would just say right now, we're really not seeing any pushback on the commercial side.

Speaker Change: And it's good to see that the Nephrologist still has the ownership and really is that the decision on the center of the decision, making and for those patients that need it on that they have commercial coverage and certainly the physician to write for it and we've got confidence that the patient can get it on the commercial side.

Eric Foster: 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 patient can get it on the commercial side. And our adult assist program is extremely helpful in navigating that process. All right, thank you.

Speaker Change: Plenty of others and our Doctor assist program is extremely helpful in navigating that process.

Speaker Change: Okay.

Unknown Executive: Thanks so much.

Speaker Change: Alright, thanks, so much.

Unknown Executive: Thank you.

Speaker Change: Thank you.

Speaker Change: Okay.

Ashley: Our next question comes from Allison Bratzel from. Hi, thanks for taking the question. This is Ashley, on for Allie. Allie Bradfield.

Speaker Change: Our next question comes from Allison <unk> from Piper Sandler.

Ashley: Hi, Thanks for taking the question. This is Ashley on for Alley.

Speaker Change: Like Russell I had two questions first one being related to expose that it seems like we haven't really heard much about the kidney patient act. It seems like this is kind of shaping up to be.

Unknown Executive: I had two questions. 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 kind of shaping up to be. what you would call a call option. Do you have any updated color on that fund? Anything you've heard?

Speaker Change: What you would call a call option do you have any updated color on that fund anything you've heard and then my second question is related to potentially bring in a G. I R adjacent externalize it.

Michael Raab: 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? Anything on that front would be really helpful.

Speaker Change: You guys previously signaled some interest in doing that.

Speaker Change: Is that still the plan do you have any color on when we might hear about this are you kind of focus more on the ongoing launches of new commercial products anything on that front would be really helpful. Thank you.

Michael Raab: Thank you. Sure, thanks for the questions. In terms of bringing up assets, as we've described, you know, we've recently built out a team with Mike Kelleher to look at corporate development in licensing acquisition 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's something to talk about both in terms of internal development of some of the approaches we could have with programs that we have developed, we will announce that as anything that we bring in from the outside.

Speaker Change: Sure Thanks for the questions.

Speaker Change: In terms of bringing assets as we've described we've recently built out a team with my color her to look at corporate development in licensing acquisition of assets certainly indirect and.

Speaker Change: In our spaces in renal and Gi and adjacent spaces as appropriate.

Speaker Change: And that work continues we are excited about progress is being made in.

Speaker Change: When there is something to talk about both in terms of internal development of some of the approaches we could have with programs that we have developed we will announce that as anything that we bring in from the outside so it is an incredibly important part of our efforts to build this enterprise.

Michael Raab: So it's an incredibly important part of our efforts to build this enterprise as we believe we can. As it relates to the CUNY Patient Act, you hit the nail on the head. Think of it as a 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 million. And that comes from 40% of the dialysis patients, which is roughly 220,000, would be our TAM. So free call option is exactly the way to think about it.

Speaker Change: As we believe we can.

Speaker Change: As it relates to the kidney patient Act you hit the nail on the head think of it as a call it free call option.

Speaker Change: What we at the end of last year. We communicated is that you should hold our feet to the fire around the $750 million and that comes from 40% of the dialysis patients, which is roughly 220000 would be our two of our Tam. So free call option is exact the way to think about it.

Unknown Executive: Great. Thank you so much. Thank you.

Speaker Change: Great. Thank you so much.

Speaker Change: <unk>.

Prakara Agrawal: Our next question comes from Prakara Agrawal from Cancer.

Speaker Change: And our next question comes from <unk> <unk> from Cantor Fitzgerald.

Unknown Executive: Hi, this is Dalbom from PCAR. I'm trying to get a better sense of the strategy around expanding Exposa uptake in our Medicare channels. Once you expect to see this from the uptake materialized within these healthcare channels, I'm sorry, I couldn't hear the entire question. Expanding exposure to Medicare, did you say? Non-medicare travels. What is the strategy around expanding exposure of non-medicare travel? Yeah, so with non-Medicare, you know, that's, that's going to be Medicaid, as I said, and commercial are the two main components of non-Medicare, and that is 40% of the patient population. They are seen by nephrologists, which are the people that we call on.

Speaker Change: Five of the album Art.

Speaker Change: It's only got about a phone company strategy around expanding into some of the uptick in non Medicare channels on once you. If I can sneak just one last thing materialize wouldn't be held clinical tunnel.

Speaker Change: I'm, sorry, I couldn't hear the entire question.

Spanning expose into Medicare did you say.

Speaker Change: <unk> was one of the strategy around the timing of close that I'll take a moment ago trauma.

Speaker Change: Yes, so with non Medicare that's gonna be Medicaid as I said and commercial are the two main components of non Medicare and that is 40% of the patient population. They are seen by Nephrologist, which 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. We have a closed distribution system that goes through our Ardelyx 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 aren't Medicare, then we work with them through the system, if there's prior ops or not, to get their prescriptions filled.

Speaker Change: And one of the important aspects of the way that we do it is we don't tell the nephrologist to discern, whose Medicare and non Medicare we have a closed distribution system that goes through our <unk> assist program. So that we adjudicate those who are Medicare and those who arent Medicare and those who are Medicare Tran.

Speaker Change: <unk> transitioned into our patient assistance program and if they qualify they get free drug.

Speaker Change: If they arent Medicare then we work with them through the system, if theres prior ops or not to get their prescriptions filled.

Speaker Change: Yeah.

That concludes our question and answer session. Now I'll turn the call over to our host for any additional or closing Thank you all for joining us this afternoon. And a special shout out goes to Team Ardelyx, 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.

Speaker Change: And that concludes our question and answer session now I'll turn the call over to our host for any additional or closing remarks.

Speaker Change: And thank you all for joining us this afternoon and a special shout out goes to TMR dogs, who I know is listening your hard work is invaluable and bringing our central medicines 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. Thank you all.

With that, we can conclude the call. Thank you, operator.

Speaker Change: Later.

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

Speaker Change: That concludes today's meeting thank you for joining and have a pleasant day.

The host has ended this call. Goodbye.

Speaker Change: The host has ended this call goodbye.