Q4 2023 Ardelyx Inc Earnings Call

Operator: Good afternoon, and welcome to the Ardelyx fourth quarter and full year 2023 financial results conference call. All participants will be in a listen-only mode.

Good afternoon, and welcome to the our Delek fourth quarter and full year 2023 financial results Conference call. All participants will be in a listen only mode should you need assistance. Please signal a conference specialist by pressing the star key followed by zero.

Operator: Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note, this event is being recorded. I would now like to turn the conference over to Kaitlin Lowey, Vice President of Corporate Communications and Investor Relations at Ardelyx.

After today's presentation there'll be an opportunity to ask questions. Please note. This event is being recorded.

I would now like to turn the conference over to Caitlin Laue, Vice President of corporate Communications and Investor Relations at our Dallas. Please go ahead.

Kaitlin Lowey: Thank you. Good afternoon, and welcome to our fourth quarter and full year 2023 financial results call. During this call, we will refer to the price release issued earlier today, which is available on the investor section of the company's website at Ardelyx.com. During this call, we will be making forward-looking statements that are subject to risks and uncertainties. Our actual results may differ materially from those described.

Caitlin Laue: Thank you good afternoon, and welcome to our fourth quarter and full year 2023 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 our Dallas Dot Com.

Caitlin Laue: During this call, we'll be making forward looking statements that are subject to risks and uncertainties. Our actual results may differ materially from those described we encourage you to review the risk factors in our most recent annual report on Form 10-K that was filed today can be found on our website at our Dallas Dotcom.

Kaitlin Lowey: We encourage you to review the risk factors and our most recent annual report on Form 10-K, which can be found on our website at ardelyx.com. However, 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.

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.

Michael G. Raab: Our president and CEO, Mike Raab, will begin today's call with opening remarks and an overview of the company's progress during the fourth quarter of 2023 and the full year 2023. Next, Susan Rodriguez, Chief Commercial Officer, will provide an update on the performance of Xtrella and Xposa. Our Chief Medical Officer, Dr. Laura Williams, will then discuss an Xposa real-world evidence study announced today. Justin Renz, Chief Financial and Operations Officer, will conclude today's prepared remarks with a review of the company's financial performance during the fourth quarter and full year ended December 31, 2023, before we open the call to questions. With that said, let me pass the call over to Mike.

Caitlin Laue: President and CEO, Mike Raab will begin today's call with opening remarks, and an overview of the company's progress during the fourth quarter of 2023 and the full year 2023.

Speaker Change: Next Excusing Rodriguez Chief commercial officer will provide an update on the performance of its rollout in <unk>, Our Chief Medical Officer, Dr. Laura Williams will then discuss and expose that real world evidence study announced today, Justin Renz, Chief financial and operations Officer conclude todays prepared remarks with a review of the company's financial performance.

During the fourth quarter and full year ended December 31, 2023, before we open the call to questions with that let me pass the call over to them.

Michael G. Raab: Good afternoon, everyone, and thank you for joining us on the call. I feel like I've said this every quarter, but we are really excited to be here to discuss our progress and performance. The fourth quarter was significant, as was all of 2023, as we continue our evolution as an integrated biotech company, bringing two first-in-class products to patients. Ezrella and Exposa are demonstrating favorable market responses with high healthcare practitioner interest and continuously expanding adoption. In November of last year, we launched Xposa, and the market response, both in terms of treatment uptake and direct feedback we received from the field, has validated what has always been clear to us, that physicians and patients have been waiting for a novel mechanism option to help control serio- As you will hear from Susan, all the indicators we track early in launch point to a strong event. Additionally, as we announced today, as part of our commitment to Laura will review more details about the study during our call today.

Speaker Change: Good afternoon.

Speaker Change: Everyone and thank you for joining us on the call.

Speaker Change: Like I've said this every quarter, but we're really excited to be here to discuss our progress and performance.

Speaker Change: The fourth quarter was significant as was all of 2023 as we continue our evolution as an integrated biotech company, bringing two first in class products to patients its rollout and expose that are demonstrating favorable market response with high health care practitioner interest and continuously expanding adoption.

In November of last year, we'd want to expose that and the market response, both in terms of treatment uptake and direct feedback we've received from the field has validated what has always been clear to us that.

Speaker Change: That physicians and patients have been waiting for a novel mechanism option to help controlled serum phosphorus.

Speaker Change: As you will hear from Susan all the indicators, we track early in launch point to a strong uptake. Additionally, as we announced today as part of our commitment to continually build our understanding of the clinical utility of our products. We're conducting a real world evidence study designed to capture the impact there and expose the based regimen okay.

On the treatment of hypercholesterolemia.

Speaker Change: Laura will review more details about the study during our call today.

Michael G. Raab: Turning to Azrela, in January, we shared our enthusiasm for the commercial progress we were making, and our expectations for Azrela are high. We shared that we believe Azrela has the potential to become a billion dollar company. The patients are there, they need relief, and many of them continue to experience symptoms despite treatment with incumbent therapy, clearly reinforcing the need for novel treatment options like Azrela, as well as a mechanism of action, solid clinical data, and a growing user base of positive experiences that resonate, driving expanding consideration and adoption by more and more healthcare practitioners. In addition to patients' positive experiences with Adrela, ACPs are beginning to change how they engage with In addition, the path for access is established.

Speaker Change: Turning to Israel in January we shared our enthusiasm for our commercial progress, we are making and that our expectations for its rollout are high we shared that we believe it's rolla has the potential to become a billion dollar drug.

Speaker Change: The patients are there they need relief and many of them continued to experience symptoms. Despite treatment with incumbent therapies clearly reinforcing the need for novel treatment options like its rollout.

Speaker Change: Israel is the mechanism of action solid clinical data and a growing user base of positive experience is resonating.

Speaker Change: Riding expanding consideration and adoption by more and more health care practitioners.

Speaker Change: With patients positive experiences with its rollout acp's are beginning to change how they engage with and treat their ibs C patients as they are expanding their use of the therapy. In addition, the path for access is established these.

Michael G. Raab: These are the fundamentals of our commercial strategy, and they are working. As we noted in January, we will always look to expand the opportunity and to ensure our medicines get to those patients who need them. Thus, we are thoughtfully investing in expanding our commercial reach. We are also thinking about what the future of Ardelyx will look like, and we find ourselves in a unique and enviable position. We have options.

Speaker Change: These are the fundamentals of our commercial strategy and they are working.

Speaker Change: As we noted in January we will always look to expand the opportunity and to ensure our medicines get to those patients who need. It. Thus we are thoughtfully investing in expanding our commercial reach.

We are also thinking about what the future of our Dallas will look like and we find ourselves in a unique and enviable position we have options.

Michael G. Raab: With both Exposa and Adrela approved in the U.S. and doing well, we are engaging potential international partners to bring these products to patients in other global markets. In addition, with our established and proven commercial organization, we are emerging as a partner of choice for development stage assets in therapeutic areas where patients continue to have unmet needs. And with our successful track record of discovery, development, and regulatory approval, we also have the opportunity to develop earlier stage assets ourselves.

Speaker Change: With both exposed on its rolla approved in the U S and doing well we are engaging potential international partners to bring these products to patients in other global markets. In addition, with our established and proven commercial organization. We are emerging as a partner of choice for development stage assets in therapeutic areas, where patients continue to have unmet needs.

Speaker Change: And with our successful track record of discovery development and regulatory approvals. We also had the opportunity to develop earlier stage assets ourselves.

Michael G. Raab: These activities are ongoing, and we look forward to sharing more information when appropriate. In the meantime, our top priority is to focus on sustaining the commercial momentum of Adderall and Exposed. I will now hand the call to Susan to share an update on our commercial activities. Thank you, Mike. It is great to be here today to share a commercial update on both Ibsrela and Xposa. Let me start with Ibsrela.

These activities are ongoing and we look forward to sharing more information when appropriate.

Speaker Change: In the meantime, our top priority is to focus on sustaining the commercial momentum of its rollout and expose.

Speaker Change: I will now hand, the call to Susan to share an update on our commercial performance Susan.

Susan: Thank you Mike It is great to be here today to share our commercial update in both Israel and expose that well, let me start with Israel, Israel has established a unique position within the Ibs C treatment paradigm and it's changing the way the HCP community treats patients with Ibs C. H C pizza.

Susan Rodriguez: Ibsrela has established a unique position within the IBSC treatment paradigm, and it's changing the way the HCP community treats patients with IBSC. HCPs that we have reached with our messaging are responding favorably to the differentiated mechanism of action and clinical data profile, adopting Ibsrela, and continuously expanding their use based on the patient responses they are seeing. Significant opportunity exists to continue to expand awareness, knowledge, and uptake across our target market. Our research has demonstrated that when healthcare professionals become aware of Ibsdrela and its first-in-class mechanism, they begin prescribing. And the more they see, hear, and learn about Ibsdrela, the more they prescribe it and expand their thinking about patients who are candidates for Ibsdrela. The fundamentals driving Ibsdrela's growth momentum are strong. IBSC is a condition of multifactorial pathophysiology, and patients need multiple mechanism therapies to improve treatment outcomes and provide additional relief.

Susan: Have reached with our messaging are responding favorably to the differentiated mechanism of action and clinical data profile adopting Israeli and continuously expanding their use based on the patient responses. They are seeing.

Susan: Significant opportunity exists to continue to expand awareness knowledge and uptake across our target market. Our researchers demonstrated that when hcp's become aware of its rollout and its first in class mechanism. They begin prescribing and the more they see here and learned about Australia, they're more they prescribe and expand their thinking.

Susan: As patients who are candidates for Australia.

Susan: The fundamentals driving a journalist gross momentum our strong Ibs C is a condition of multifactorial pathophysiology and patients need multiple mechanism therapies to improve treatment outcomes and provide additional relief.

Susan Rodriguez: Prior to the launch of Ibsdrella, there was a single class of drugs available for patients with a large unmet need across patients whose symptoms persisted despite treatment with these therapies. IVSC prescriptions are concentrated across an accessible group of HCPs who have demonstrated to be very responsive to both our field-based sales team as well as our omni-channel digital engagement program. A favorable access profile is established, and interest is high.

Susan: Prior to the launch of its dollar there was a single class of drugs available for patients with a large unmet need across patients whose symptoms persisted. Despite treatment with these therapies I do see prescriptions are concentrated across an accessible group of Hcp's, who had demonstrated to be very responsive to both our field based sales.

Susan: Team as well as our omni channel digital engagement programs.

Susan: A favorable access profile is established.

Susan: Interest is high responds to a gel or profile is driving adoption.

Susan Rodriguez: Response to the Abdrella Profile is driving adoption, and favorable treatment experiences are driving expanded use, which, in turn, is driving a continuously expanding view of patients who are candidates for Xrela therapy. We continue to see consistent, persistent growth of Ibsrela across all key performance metrics. Additionally, new prescriptions are growing. Refill prescriptions are growing, new riders are growing, and use across the existing rider base is growing steadily. These foundational elements will be leveraged and built upon as we increase our investment in Ibsrela in 2024. You can expect to see continued steady growth throughout the year.

Susan: Favorable treatment experiences are driving expanded use which in turn is driving it continuously expanding view of patients who are candidates for therapy.

Susan: We continue to see consistent persistent growth of Israel up across all key performance metrics, new prescriptions are growing refill prescriptions are growing new writers are growing end use across the existing writer base is persistently growing these foundational elements will be leveraged and built upon.

Susan: As we increase our investment in Israel are in 'twenty 'twenty four.

Susan: You can expect to see continued steady growth throughout the year.

Susan Rodriguez: Turning to Xposa, at just three months since its launch in November, we are very pleased to see the market responding as we anticipated. The high level of awareness, interest, and intent to adopt has translated into strong initial product uptake. The $2.5 million in revenue we reported during the fourth quarter, but really from mid-November through the end of December, validates that there were patients and physicians who were waiting for first-in-class phosphate absorption inhibitor Exposa as a much-needed option for patients who were not able to achieve target serum phosphorus levels with phosphate binders alone or who were intolerant of phosphate binders. We are continually hearing from physicians Additionally, patients are responding favorably to the single-tablet, twice-daily dosing profile of Xposa, both when it is added to their binder regimen or when the HCP chooses to discontinue their binder therapy and initiate treatment with Xposa.

Susan: Turning to expose that at just three months since launched in November we are very pleased to see the market responding as we anticipated the high level of awareness interest and intent to adapt has translated into strong initial product uptake.

Susan: The $2.5 million in revenue, we reported during the fourth quarter, but really from mid November through the end of December validate that there are patients and physicians who were waiting for first in class phosphate absorption inhibitor expose that as a much needed option for patients who are not able to achieve target serum phosphorus level with phosphates.

Susan: Anders along or who are intolerant of phosphate binders.

Susan: We are continually hearing from physicians, who say that patients who are on an extensive base regimen are experiencing positive results.

Susan: Additionally, patients are responding favorably to the single tablet twice daily dosing profile of expose that both when its being added to their binder regimen or when the HCP chooses to discontinue their binder therapy and initiate treatment with exposure.

Susan Rodriguez: In addition to a positive therapeutic response and patient experience reported by physicians, we are rapidly establishing a favorable access landscape for EXPOSA. Payers are establishing coverage policies that provide access to EXPOSA via prior authorization for patients who are not adequately responding to binder therapy or are intolerant of binder therapy. Nephrologists report to us that a large subset of their patients meet these criteria, and nephrologists are demonstrating a willingness to engage in the administrative PA process to secure access to therapy for these patients as they believe they are in need of a novel mechanism approach. At this point, we are seeing patients access EXPOSA across all commercial and government payers. In addition, we are seeing patients take advantage of the resources available through our patient services programs, including our copay pay-down program and patient assistance program for qualifying patients.

Susan: In addition to our positive therapeutic response and patient experience reported by physicians, we are rapidly establishing a favorable access landscape or expose that.

Susan: Payers are establishing coverage policies, which provide access to expose that by a prior authorization for patients who are not adequately responding to binder therapy or are intolerant to find her therapy.

Susan: Nephrologist report to us that a large subset of their patients meet these criteria and nephrologists are demonstrating a willingness to engage in the administrative P. A process to secure access to therapy for these patients as they believe they are in need of a novel mechanism approach.

Susan: At this point, we are seeing patients access expose that across all commercial and government payers. In addition, we are seeing patients take advantage of the resources available through our patient services programs, including our co pay pay down program and patient assistance programs for qualifying patients.

Susan Rodriguez: Finally, we are also seeing strong market interest and responsiveness to our in-market messaging centered on the novel phosphate blocking mechanism and clinical profile of exposome. Our EXPOSA-dedicated sales force of 60 is finding nephrology offices across the country welcoming and eager to learn more. Our digital and in-person educational sessions are highly attended, and our various omni-channel digital communications are seeing high levels of engagement.

Susan: Finally, we are also seeing strong market interest and responsiveness to our in market messaging centered on the novel phosphate blocking mechanism and clinical profile of expose them.

Susan: Alright expose a dedicated sales force of 60 are finding nephrology offices across the country welcoming and eager to learn more or digital and in person educational sessions are highly attended and our various omnichannel digital communications are seeing high levels of engagement.

Susan Rodriguez: These are all positive launch indicators that we believe will result in continued, consistent, and persistent uptake. The foundational elements of the Ardelyx commercial approach are all working together, and we are incredibly pleased with the performance thus far. What we see is consistent and persistent growth driven by market need, favorable market access, and key demand creation fundamentals that are delivering on the mission of Ardelyx, to bring a novel mechanism therapy to patients who, despite treatment with available therapies, are in great need of a new option. It is an exciting time for our team and for Ardelyx.

Susan: These are all positive launch indicators that we believe will result in continued consistent and persistent uptake.

Susan: The foundational elements of the our Dallas commercial approach are all working together and we are incredibly pleased with the performance. Thus far what we see is consistent and persistent growth driven by the market need favorable market access and key demand creation fundamentals that are delivering on the mission of our Delhi.

Susan: To bring a novel mechanism therapy to patients who despite treatment with available therapies are in great need of a new option.

It is an exciting time for our team and BARDA, Alex the growth momentum, we are seeing for both Israel and expose that is exciting and the team is laser focused on sustaining this momentum with the strategic intent to reach all patients in need of our first in class therapies I look forward to continuing to share updates with you.

Susan Rodriguez: The growth momentum we are seeing for both Ibserella and Exposa is exciting. The team is laser-focused on sustaining this momentum with the strategic intent to reach all patients in need of our first-in-class therapies. I look forward to continuing to share updates with you in the future. With that, I will hand it to Laura. Thank you, Susan. I'm really pleased to join you today.

Susan: In the future with that I will hand, it to Lora.

Lora: Thank you Susan I'm really pleased to join you today.

Dr. Laura Williams: In addition to all the great work that Susan shared with you in support of Ipsrella and Xposa, we also continue to expand our medical and clinical understanding of our products. Medical Education for Patients and HCPs, as well as data dissemination via abstracts, presentations, and publications, continue to provide valuable insights and enhance the science around our products and, more generally, within these therapeutic areas. Which brings me to one of the data gathering programs that I'm extremely excited about. Today we announce that we will be initiating a real-world evidence study of exposures. As we know in clinical development, gaining a real-world understanding of our therapies can vastly increase our knowledge of how these drugs are impacting patients outside of the more controlled clinical setting, complementing our overall understanding of the treatment paradigms for our patients. Real-world evidence studies can shine additional light on the safety, tolerability, and effectiveness of a therapy and provide greater insight into epidemiology, disease burden, treatment patterns, treatment adherence, impact on quality of life, and importantly, how a new drug, like Xposa, integrates into a patient's lived experience.

Lora: In addition to all the great work that Susan shared with you in support of Israel and expose them. We also continued to expand our medical and clinical understanding of our products.

Lora: Medical education for patients in Hcp's as well as data dissemination via abstract presentations and publications continue to provide valuable insights and enhance the science around our products and more Julie within these therapeutic areas.

Lora: Which brings me to one of the data gathering programs that I am extremely excited about.

Lora: Today, we announced that we will be initiating a real world evidence study of exposure.

Lora: As we know in clinical development, gaining a real world understanding hard therapies can vastly increase our knowledge of how these drugs are impacting patients outside of the more controlled clinical setting complementing our overall understanding of the treatment paradigms for our patients.

Lora: All the evidence studies can sign additional light on the safety Tolerability and effectiveness of a therapy and provide greater insight into the epidemiology disease burden treatment patterns three minute here and impact on quality of life and importantly, our new drug like exposure integrates into a patient.

Lora: <unk> lived experience.

Dr. Laura Williams: We anticipate that these types of data will provide Ardelyx with additional insights to help us support the patient and physician communities as they integrate EXPOSA into their treatment practices. It will also help us develop educational materials for patients to maximize their understanding of the drug and potentially enhance their experience, while continuing to highlight the favorable benefit-risk profile of exposants, and it will also support ongoing discussions with payers. This will be a real-world, long-term, prospective, observational cohort study designed to capture the impact of exposure-based regimens in patients with hyperphosphatemia on maintenance dialysis who were either not controlled on or intolerant of binder therapy.

Lora: We anticipate that these types of data, we will provide our delek with additional insights to help us support the patient and physician community as they integrate expose them into their treatment practices and will also help us develop educational materials for patients to maximize their understanding.

Lora: Of the drug and potentially enhance their experience, while continuing to highlight the favorable benefit risk profile of expose.

Lora: And then we will also support ongoing discussions with payers.

Lora: This will be a real world long term prospective observational cohort study designed to capture the impact of exposure based regimens in patients with hyper phosphatase on maintenance dialysis, who were either not controlled on or intolerant of Binded therapy.

Dr. Laura Williams: To that end, patients on the Xposa-based regimen will include those who are using Xposa in combination with phosphate binders, as well as those who are taking Xposa as monotherapy. We will follow these patients for a period of up to three years to understand the persistence of treatment effectiveness in achieving and maintaining serum phosphorus within the guideline recommended range. This extended analysis period will also allow us to examine changes in treatment patterns, discontinuation rates across treatment regimens, and the impact of an exposure-based regimen on patient satisfaction. I am very excited about what Xposa may be able to do for our patients. And capturing data in a real-world setting will not only supplement the insights we've gained in our clinical trials but, more importantly, will further expand our understanding and enhance our ability to support the patients and the physician communities who are constantly striving to manage serum phosphorus in the setting of end-stage kidney disease. I look forward to sharing more detail and results from this trial in the future. I will now pass it on to Justin.

Lora: To that end patients on the exposed to base regimen will include those who are using expose it in combination with phosphate binders as well as those who were taking expose it as monotherapy.

Lora: We will follow these patients over a period of up to three years to understand the persistence of treatment effectiveness and achieving and maintaining serum phosphorus within the guideline recommended range.

Lora: This extended analysis period will allow us to also examine changes in treatment patterns discontinuation rates across treatment regimens and the impact of an extra load debase regimen on patient satisfaction.

Lora: I am very excited about what exposure may be able to do for our patients and capturing data in a real world setting will not only supplement the insights we've gained in our clinical trials, but more importantly will further expand our understanding and enhance our ability to support the patients and the <unk>.

Lora: Asian communities, who are constantly striving to manage serum phosphorus in the setting of end stage kidney disease I look forward to sharing more detail and results from this trial in the future I will now pass it to justice.

Justin A. Renz: Thank you, Laura. Earlier in January, we pre-announced our product revenue, so I'll use this as an opportunity to review that material and highlight additional key financials from the fourth quarter and full year 2023. What I believe you will hear from the information we have provided today is that we find ourselves in a strong financial position.

Justice: Thank you Laura.

Justice: Earlier in January we pre announced our product revenue.

Justice: So I'll use this as an opportunity to review them materials and highlight additional key financials from the fourth quarter and full year 2023.

Justice: What is leave you with the information we provided today, we find ourselves in a strong financial position.

Justin A. Renz: We are well-resourced, we have multiple revenue streams, and we are thoughtfully investing in continued growth. We had total revenues of $34.4 million in the fourth quarter of 2023, driven by growth in net product sales revenue. On a full year basis, we reported total revenues of $124.5 million in 2023, compared to $52.2 million in 2022. Our significant year-over-year growth was driven primarily by the strong performance of Indrella.

Justice: Well resource we have multiple revenue streams, we are thoughtfully investing in continued growth.

Justice: We had total revenues of $34 $4 million in the fourth quarter of 2023, driven by growth in net product sales revenue.

Justice: On a full year basis, we reported total revenues of $124 $5 billion in 2023 compared to $52 $2 million in 2022.

Justice: Our significant year over year growth was driven primarily by the strong performance of its wrong.

Justin A. Renz: I will now take a moment to walk through the relative contributions of our revenue components during the fourth quarter and full year. First, we had U.S. net product sales revenue from Israel in the quarter ended December 31, 2023 of $28.1 million, a 26% quarter-over-quarter increase from the $22.3 million we reported in the third quarter. On an annual basis, we recorded $80.1 million in IMSRELA U.S. net product sales revenue in 2023 compared to $15.6 million in 2022 as a result of consistent and persistent growth in all key VETs. We also recorded $2.5 million in U.S. net product sales revenue for Xposa in the fourth quarter following the launch in November. Second, we reported $3 million in licensing revenue in the fourth quarter, bringing our full-year licensing revenue total to $35.8 million, which is comparable to the $35 million in licensing revenue that we will recognize in 2022.

Speaker Change: I'll now take a moment to walk through the relative contributions of our revenue components during the fourth quarter and full year.

Justice: Sure.

U S net product sales revenue of its role in the quarter ended December 31 2023.

$28 $1 million, a 26% quarter over quarter increase from the $22 $3 million, we reported in the third quarter.

Justice: On an annual basis, we recorded $81 million of its rella U S. Net product sales revenue in 2023 compared to $15 $6 million in 2022, as a result of consistent and persistent growth in all key metrics.

Justice: We also recorded $2 $5 million in U S. Net product sales revenue exposure in the fourth quarter. Following the launch in November.

Justice: Second we reported $3 million in licensing revenue in the fourth quarter, bringing our full year licensing revenue total to $35 $8 million, which is comparable to the $35 million in licensing revenue we recognized in 2022.

Justin A. Renz: Finally, we reported product supply revenue of approximately $800,000 in the fourth quarter and $6.1 million for the full year of 2023 compared to $1.5 million during the full year of 2022. Research and development expenses were $9.5 million in the fourth quarter of 2023, compared to $9.1 million for the same quarter of 2022. In 2023 and 2022, R&D expenses were $35.5 million and $35.2 million, respectively. Selling, general, and administrative expenses were $47.7 million in the fourth quarter of 2023, an increase of $28 million from the $19.7 million we reported for the same period of 2022. The increase was due to the costs associated with the continued commercialization and growth of Ipsarella, as well as the launch activities for Xposa. On a full-year basis, total SG&A expenses were $134.4 million compared to $76.6 million in 2022.

Justice: Finally, we reported product supply revenue of approximately $800000 in the fourth quarter and $6 $1 million for the full year of 2023 compared to $1 5 million during the full year of 2022.

Justice: Research and development expenses were $9 5 million of fourth quarter of 2023 compared to $9 1 million for the same quarter of 2022.

Justice: 2023, and 2022, R&D expenses were $35 5 million and $35 2 million respectively.

Justice: Selling general and administrative expenses were $47 7 million for the fourth quarter of 2023, an increase of $28 million from the $19 7 million, we reported for the same period of 2022.

Justice: The increase was due to the costs associated with the continued commercialization and growth of its rollout as well as the launch activities for exposure.

Justice: On a full year basis total SG&A expenses were $134 $4 million compared to $76 6 million in 2022.

Justin A. Renz: We had a net loss of approximately $28.8 million, or $0.12 per share, in the fourth quarter of 2023, compared to net income of $10.7 million, or $0.06 per fully diluted share, in the same period of 2022. The net loss for the fourth quarter of 2023 includes $5 million in combined non-cash expenses from share-based compensation and non-cash interest expense related to the sale of future royalties. Our net loss for the full year 2023 was $66.1 million, or $0.30 per share, which included $17.9 million of non-cash expenses from share-based compensation, non-cash interest expense related to the sale of future royalties, and impairment of a right-of-lease use asset.

Justice: We had a net loss of approximately $28 $8 million or <unk> 12 per share in the fourth quarter of 2023 compared to net income of $10 7 million or six cents per fully diluted share in the same period of 2022.

Justice: The net loss for the fourth quarter of 2023 includes $5 million in combined noncash expenses from share based compensation and noncash interest expense related to the sale of future royalties.

Justice: Our net loss for the full year 2023 was $66 1 million or <unk> 30 per share, which included $17 9 million of noncash expenses share based compensation noncash interest expense related to the sale of future royalties and impairment of our right of way.

Use asset.

Justin A. Renz: In 2022, we reported a net loss of $67.2 million, or 42 cents per share for the full year. As of December 31, 2023, we had total cash, cash equivalents, and short-term investments of $184.3 million as compared to $123.9 million at the end of 2022. This includes $22.4 million in net proceeds that we drew in mid-October from our term loan agreement with SLR Capital, which we announced following the approval of the transactions. In addition to our cash as of December 31, 2023, in January, we received a $3 million milestone payment from Fosun Pharma following the U.S. approval of its Fosun, We also intend to draw the next $50 million tranche from our Term 1 agreement with SLR prior to the expiry of this option on March 15, 2024.

Justice: 2022, we reported a net loss of $67 2 million or 42 per share for the full year.

Justice: As of December 31, 2023, we had total cash cash equivalents and short term investments of $184 $3 million as compared to $123 9 million at the end of 2022.

Justice: This includes $22 $4 million in net proceeds that we drew in mid October from our term loan agreement with <unk> capital, which we announced following the approval of exposure.

Justice: In addition to our cash as of December 31, 2023 in January we received a $3 million milestone payment from <unk> pharma following the U S improving disposal.

Justice: We also intend to draw the next $50 million tranche from our term loan agreement with SLR prior to the expiry of this option on March 15 2024.

Justin A. Renz: Now, let me take a few minutes to give you some insights into what we currently expect for 2024, first as it relates to Umbrella. Our strong performance in 2023 was driven by consistent uptake for OBSERVA across each of our key measures, including new riders, repeat riders, as well as new and refill prescriptions. Zrella's performance to date and, as Susan shared earlier, the continued insight from our in-field experience has strengthened our confidence in the potential for this product. As a result, in January, we announced we currently expect Zrella's U.S. net product sales revenue for the full year 2024 to be between $140 and $150 million.

Speaker Change: Now let me take a few minutes to give you some insight as to what we currently expect for 2024.

Speaker Change: First as it relates to Tims ROA.

Speaker Change: Our strong performance in 2023 was driven by consistent uptake Forbes ROA across each of our key measures, including new writers repeat writers as well as new and refill prescriptions as.

Speaker Change: As Ralph performance to date and as Susan shared earlier, the huge insight from our infield experience has strengthened our confidence in the potential for this product as a result in January we announced we currently expect to draw on U S. Net product sales revenue for the full year 2024 to be between 140 and 150.

Speaker Change: Yeah.

Justin A. Renz: As a reminder, our guidance does not include any anticipated EXPOSA, partner milestone payments, or product supply revenues. As we've continually done since the launch of Absarella, we have thoughtfully increased our investment as our internal expectations evolve. We began additional planned investments in our sales and marketing in January, including the expansion of our field presence from 64 to 124 dedicated to Xtrella, as well as increasing our spending on marketing initiatives, including additional engagement, product sampling, and our patient support services. As a result, by the third quarter of 2024, we anticipate incurring incremental operating expenses averaging approximately $20 million more per quarter when compared to the fourth quarter of 2023.

As a reminder, our guidance does not include any anticipated expose the partner milestone payments or product supply revenues.

As we've continually done since the launch of its rollout we have thoughts we increased our investment as our internal expectations evolve. We began additional planned investments into our sales and marketing in January including the expansion of our field presence from 64 to 124 getting into a trailer as well as increasing.

Speaker Change: Our spending and marketing initiatives, including digital engagement product sampling and our patient support services.

Speaker Change: As a result by the third quarter of 2024.

Speaker Change: Anticipate incurring incremental operating expenses, averaging approximately $20 million more per quarter, when compared to our fourth quarter of 2023.

Justin A. Renz: We feel confident that our current cash position will support our expected spend, including these investments. We are excited about Israel's performance, the early days of Exposa, and the strength of our cash position. We will continue to be thoughtful with how we deploy capital while focusing on maximizing shareholder value. With that, I'll hand it back to Mike. Thanks, Justin.

Speaker Change: We feel confident that our current cash position will support our expected spend including these investments.

Speaker Change: We are excited about it drove the performance the early days of exposure and the strength of our cash position. We will continue to be thoughtful with how we deploy capital while focusing on maximizing shareholder value with that I'll hand, it back to Mike.

Michael G. Raab: Thanks, Justin we accomplished a lot in 2023, and we're not yet done and we're not looking back 2024 is going to be yet another important and exciting year for our <unk>. We are looking ahead and our team is more aligned than ever on the company's path forward.

Michael G. Raab: We accomplished a lot in 2023, and we're not yet done, and we're not looking back. 2024 is going to be yet another important and exciting year for Ardelyx. We are looking ahead, and our team is more aligned than ever on the company's path forward. I will now open the call to questions. Daniel. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the key.

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

Daniel: We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.

Daniel: If youre using a speakerphone please pick up your handset before pressing the keys.

Operator: To withdraw your question, please press star then 2. Our first question comes from Dennis Ding from Jeffries. Please go ahead. Hi, thanks for taking our questions and congratulations on all the progress. So, a few questions for me. For EXPOSA's growth plan, can you remind us your guidance on that and the various pushes and polls that could take place in Q1, given you guys have made some comments on things like co-pays? Patient Assistance Programs. And then question number two is also on EXPOSA, but around HR 5074. I appreciate this is sort of out of your control, but could you elaborate on some of the different scenarios that could come out of this and that you're confident in your ability to manage them? Thank you.

Daniel: To withdraw your question. Please press Star then two.

Daniel: The first question comes from Dennis Deng from Jefferies. Please go ahead.

Dennis Deng: Hi, Thanks for taking our questions and congratulations on all the progress. So two questions for me for expose those gross to net can you remind us.

Dennis Deng: Your guidance on that in the various pushes and pulls that could take place in Q1. Given you guys have made some comments on things like co pay assistance and patient assistance programs and then question number two is also on expose it but around HR 50, Sony for.

Dennis Deng: I. Appreciate this is sort of out of your control, but can you elaborate on some of the different scenarios that could come out of this thing that you're confident in your ability to manage the business in each of these scenarios. Thank you.

Michael G. Raab: Sure, Dennis, let me address the second question first, and then I'll pass it off to Justin for some discussion on gross net. You hit the nail on the head. We can't predict what's going to happen in Washington.

Dennis Deng: Sure Dennis Let me address the second question first and then I'll pass it off to Justin for some discussion on gross to net.

Justin A. Renz: You hit the nail on the head, we can't predict what's going to happen in Washington.

Michael G. Raab: We're very confident with the approach that we're taking in the business with Xposa and, you know, obviously, continue to monitor and participate as much as is practicable in what's trying to be accomplished in DC. Obviously, the broader questions there in terms of continued resolution of government functioning are what the priority is there in DC, and we will continue to update you and everyone else when anything changes with the work that's being done. Hi Mike. Hi Dennis.

Speaker Change: We're very confident with your approach that we're taking in the business with exposure and obviously continue to monitor and participate as much as is practicable.

Justin A. Renz: And we're trying to be accomplished in D. C. Obviously, the broader questions. There in terms of the continuing resolution. The government functioning is what the priority is there and do you see them and we will continue to update you and everyone else says.

Justin A. Renz: When anything changes with the work that's being done there.

Justin A. Renz: Justin.

Justin A. Renz: Thanks, Mike Hi, Dennis so for.

Justin A. Renz: So, for the fourth quarter, our gross net deduction was in line with our expectations at, you know, approximately 21%. General speaking, at this stage, it's too early to tell what we can expect with, you know, any high level of specificity or detail. What we can say is, generally speaking, we expect that, you know, we may see a higher percentage of exposure patients on Medicare compared to Ipsarella. So, you know, due to the government segment rebate dynamics, we expect that the gross net deduction may be slightly unfavorable for exposure compared to Ipsarella, but it's somewhat early, and of course, we don't, haven't really experienced seasonality Thank you. The next question comes from Chris Raymond of Piper Sandler. Please go ahead.

Justin A. Renz: For the fourth quarter, our gross to net deduction was in line with our expectations at approximately 21%.

Speaker Change: Generally speaking at this stage, it's too early to tell when we can expect with any high level specificity or detail.

Speaker Change: What we can say is generally speaking we expect that we may see a higher percentage of explode the patients on Medicare compared to as Rolla.

Speaker Change: Due to the government segment rebate dynamics, we expect that the gross to net deduction, maybe slightly unfavorable for disposal compared to its role, but it's somewhat early and of course, we don't haven't really experienced the seasonality yet because it's obviously the first time.

Speaker Change: Watching certain selling expenses in the first quarter of calendar year.

Speaker Change: Got it thank you.

Speaker Change: The next question comes from Chris Raymond of Piper Sandler. Please go ahead.

Operator: Hey, thanks, and congratulations from us, too, on the progress. Maybe two questions, and they're both on Xposa. So, just in this three-year observational study, you know, at least in terms of the SPIRIX data that we get, and I know you guys get that too, intent to prescribe is really robust, awareness is almost universal, and there's just a ton of evidence that doctors are, at least initially, very satisfied with the drug. And it seems like the pinch point really is access, as you might expect right now.

Christopher Joseph Raymond: Hey, thanks.

Christopher Joseph Raymond: And congrats from us to them on the progress maybe two questions and they're both on exposure.

Christopher Joseph Raymond: So and just on the three year observational study yeah at least in terms of the spirits data that we get and I know you guys get that too intent to prescribe you know is really robust awareness almost universal and.

Christopher Joseph Raymond: And there's just a ton of evidence of doctors at least initially here very satisfied with the drug and.

Christopher Joseph Raymond: And it seems like the pinch point really is access as you might expect right now. So I guess the question is what maybe what commercial itch does this trial scratch you know with that kind of reception you've got already had.

Michael G. Raab: So I guess the question is, maybe what commercial itch does this trial scratch, you know, with that kind of reception you've already had, or is there a regulatory commitment that this fulfills? And then I've got a follow-up. Yeah, and let me just quickly address that, and then I'll pass on to Laura for any other comments.

Christopher Joseph Raymond: Or is there a regulatory commitment that this fulfills.

Speaker Change: And then I've got a follow up.

Yeah, and let me just quickly address that and then I'll pass on to Laura for any other comments no regulatory commitment for this this is as Laura said in her comments, our continued commitment to understanding the clinical utility and where and how.

Michael G. Raab: This is, as Laura said in her comments, our continued commitment to understanding the clinical utility and where and how a product like Xposa can be used. And, you know, it's certainly curiosity, but it's also, you know, understanding that as this continues to grow, there will be questions and thoughts from payers and others that we want to be prepared to answer. And the only time to start is before you get those questions.

Speaker Change: Product like as far as it can be used and it certainly curiosity, but it's also you know understanding that as this continues to grow there's going to be questions and thoughts from payers and others that we want to be prepared to answer and the.

Laura Williams: The only time to start is before you get to those questions. So it's better to have these data than not.

Michael G. Raab: So it's better to have this data than not, and it has as much to do with our belief in the clinical utility of capturing the data. Laura, anything to add?

Laura Williams: And it has as much to do with our belief in the clinical utility and capturing the data demonstrating that Laura anything to add.

Dr. Laura Williams: Yeah, Mike, I think the only other piece to add is, you know, again, this, as you said, no regulatory commitment. This really reflects our desire to better understand the impact that a drug like Expoza could have on patients. We think that impact will be positive, and I think the other piece of it is, we also want to get a sense of patient satisfaction. When you launch these drugs, you obviously have an objective to address unmet needs, and I think the ability to capture data on, you know, how patients are experiencing these drugs in their day-to-day, you know, sort of quality of life settings is really, really important. Okay, great. Thanks.

Laura Williams: Yeah, Mike I think the only other piece that as you know.

Laura Williams: Again. This is you said no regulatory commitment this really reflects.

Laura Williams: Our desire to better understand the impact that a drug like exposure.

Laura Williams: Can have on patients, we think that impact will be positive and I think the other piece of it is we also want to get a sense of patient satisfaction.

Laura Williams: <unk> launch. These drugs you you obviously have an objective to address unmet needs and I think the ability to capture data on how patients are experiencing these drugs in their lives.

Laura Williams: Day to day sort of quality of life.

Laura Williams: Settings is really really important.

Okay, great, Thanks, and maybe a follow up.

Susan Rodriguez: And maybe a follow-up. Yes, Susan, in your comments, you mentioned, you know, out-of-the-gate working through prior rejections, expecting that out-of-the-gate. But again, back to the SPHERICS data, that it looks like about 20% or so of patients do not involve prior off. Can you give a little bit of color, I guess, on maybe the dynamic going forward? Is it the goal to reduce the number of patients requiring prior authorization? reduce the sort of lead time or the turnaround time for those or both or any sort of comment on that dynamic? What your, you know, focus items are as you try to streamline the process for action? Yeah, thanks, Chris.

Laura Williams: Susan in your comments you mentioned.

Laura Williams: Out of the gate working through prior off expecting that out of the gate, but again back to the spirits data that.

Laura Williams: It looks like about 20% or so of patients do.

Do not involve prior off can you give a little bit of color I guess on maybe the dynamic going forward is it is it the goal to reduce the number of patients requiring prior offs.

Laura Williams: Reduce the sort of lead time or the turnaround time for those or both or cause any sort of comment on that dynamic and what you're you know.

Laura Williams: Focus items are as you try to streamline the process for axis.

Laura Williams: Yeah. Thanks, Chris Yeah are we have been engaged with payers really months in advance of the approval post approval now with the final label and they are they are defining their coverage policies really exactly as we anticipated very consistent with our label.

Susan Rodriguez: Yeah, we have been engaged with payers really months in advance of the approval, post-approval, now with the final label, and they're defining their coverage policies really exactly as we anticipated, very consistent with our labels, providing a path to access via prior authorization, requiring the patient to have been treated with binders previously, inadequately responding, or intolerant of binders. So that is really our go-to-market strategy because we, at this time, do not intend to engage in contracting with payers. You know, Xposa is the only non-binder software available.

Laura Williams: Providing a path to access via our prior authorization requiring the patient to have been treated on binders previously inadequate responding or intolerant of binders. So that we that is really our go to market strategy because we at this time do not intend to engage in contracting with the pairs you know expose.

Laura Williams: That is the only non binder available. It is a first in class phosphate absorption inhibitor C. Only option now for patients that have been treated on binders and has been found to be inadequate. So so we really are not going to be contracting and there is no path forward for our formulary position that is gonna be first you know before.

Susan Rodriguez: It is the first-in-class phosphate absorption inhibitor. It's the only option now for patients that have been treated with binders and have been found to be inadequate. So we really are not going to be contracting.

Susan Rodriguez: There is no path forward for a formulary position that is going to be first, you know, before treatment with binders. So the prior-off path is the direction that we're on. So what's critical for our commercial success is the comprehensive patient services support in the office to enable that prior authorization process and get the physicians in the office comfortable with that process. And what we're finding, exactly like Ibserella, once they run through the process a few times, they get more and more comfortable with it and realize that when they go through that administrative process, the patient ends up having access to Xposa because of all of our patient assistance programs So both from an access and affordability standpoint, our patient services really enable the physician to successfully navigate that reimbursement process.

Laura Williams: Yeah treatment with find her so the prior off path is the direction that we're on so what is critical for our commercial success is the comprehensive patient services support in the office to enable that prior off process and getting the acquisition and the office comfortable with that process and what we're finding exactly is withdraw all at once.

Laura Williams: They run through the process, a few times and they get more and more comfortable with it and realize that when they go through that administrative process. The patient ends up having access to expose them because of all of our patient assistance programs and our ability to buy down there commercial copay. So both from an access and affordability standpoint, or a patient services.

Susan Rodriguez: So for us, the success in the access path is really continuing to support that nephrology interest in wanting to go through the process because they believe the patient's in need of Xposa and supporting them through that process. What we're finding so far is that when they do so, we get those prior approvals, and patients are gaining access to Xposa. Great. Thanks so much.

Operator: The next question comes from Laura Chico from Wedbush. Please go ahead. Hey, good afternoon. Thanks very much for taking the questions. One on Exposa and then one on Azrela.

Michael G. Raab: For Exposa, could you just talk a little bit more about at what point you would move to secure Tadapa for Exposa? And how should we think about the base case in terms of the duration for which it would be active? I'm not sure if the calcium and medic experience would be a relevant proxy here. Yeah, so Laura, you know, I think we're still trying to determine that as well, obviously, if we go into depth, but we've got to go through getting the proper codes and doing that. So I think as we get closer to that and get more clarity, we'll provide that comment. Okay, and then back to Ibsirella, I think Susan made the comment that you have kind of a changing view on who might be a good patient for this drug as you get more experience and exposure. Could you just expand on that a little bit further?

Laura Williams: So I think as we get closer to that and get more clarity will provide that commentary.

Speaker Change: Okay, and then back to if the roller I think Susan made the comment that you had kind of a changing view on who might be a good patient for this drug is.

Speaker Change: Getting more experience and exposure could you just expand on that a little bit further and I guess it was specifically I'm trying to understand a little bit more about how you're thinking about utilization earlier in the disease process or are you seeing signs of earlier utilization with a thriller.

Michael G. Raab: And I guess specifically, I'm trying to understand a little bit more about how you're thinking about utilization earlier in the disease process. Are you seeing signs of earlier utilization with Ibsirella? Yeah. Actually, it's really an expanding view.

Speaker Change: Yeah, actually it's really and expanding do Ya. So what we're finding is that now that the H D. PS you treat Ivy S. C have a novel mechanism option. They are increasingly identifying and aware of the patients that they had treated with GCC agonist, but they're having <unk>.

Susan Rodriguez: So what we're finding is that now that the HCPs who treat IBSC have a novel mechanism option, they're increasingly identifying and aware of the patients that they have treated with GCC agonists but are having persistent symptoms and really could benefit from a novel approach. So it's really the patients they treat every day, particularly these high-riding HCPs that we're focused on. Every patient that they see has likely been tried on a GCC agonist or is on a GCC agonist.

Speaker Change: Symptoms and really could benefit from a novel approach. So their act, it's really the patients. They treat every day, particularly these high writing a C. P. As it were focused on every patient that they see has likely been tried on the G. C. C agonists or is on a GCC agonists and what we're finding Saddam.

Susan Rodriguez: And what we're finding is that physicians are increasingly identifying these patients, engaging them in dialogue, and saying, hey, there is a new therapy option available now that I really think you could benefit from. So they're expanding their view on patients now that actually could benefit from a novel approach since they've seen good results for IBSRELA in the patients they initially tried it on. Thank you. The next question comes from Luis Chen from Canterford, Searles. Please go ahead.

Speaker Change: Patients implicitly me the prior authorization criteria and what we're finding is that physicians are increasingly identifying them engaging them in dialogue and saying Hey, there's a new therapy option available now that I really think you could benefit from so they're just they're expanding their view on patients now that actually could benefit from a novel approach.

They've seen the good results Berg Zarella in there and then the patients. They initially tried it on.

Thank you.

Speaker Change: The next question comes from Louise Chen from Cats are Fitzgerald. Please go ahead.

Operator: Hi, congratulations on all the progress and thanks for taking my questions. So, including the drawdown that you expect in March, what do you estimate your cash runway to be? And then also on Tanaponur, I saw that you have a potential regulatory action coming in China, so just curious how big that opportunity could potentially be for you. And then same question for Japan with the launch.

Louise Chen: Hi, Congratulations and all the progress and thanks for taking my questions. So I wanted to ask you, including the draw down that you expected March what do you estimate your cash runway to be and then also on can happen or I I saw that you have a potential regulatory act.

Louise Chen: <unk> coming in China, So just curious.

Louise Chen: How big that opportunity could potentially be for you and then the same question for Japan with the launch how should we think about revenues in Japan in first quarter 24 and beyond thank you.

Michael G. Raab: How should we think about revenues in Japan in, you know, first quarter 24 and beyond? Sure, let me address a couple of those things, and then I'll pass it off to Justin. Recall that what we did with our relationship with KKC in Japan is we monetized those royalties.

Speaker Change: Sure. Let me just a couple of those things and then I'll basketball congestion recall, what we goodwill or relationship would take issue in Japan monetize those royalties right. So you shouldn't expect anything more coming from our apartment in Japan, and you know talk to <unk>.

Michael G. Raab: So you shouldn't expect anything more coming from our partnership in Japan, and it's up to KKC to speak to what kind of revenues they would expect out of their market. With our relationship in China, there are certainly some regulatory actions that can happen there. We've not really spoken a whole lot about what the opportunity is, and I think we'll hold off on that as well. In terms of the drawdown in March, we're probably not going to give you any specific numbers in terms of runway and what that provides, but if you can address that. Sure. Thank you, Luis, and thank you, Mike.

Speaker Change: For you to speak to what kind of revenues they would expect out of their market with our relationship in China.

Speaker Change: I was trying to do some regulatory options that can help in there we've not really spoken a whole lot about what the opportunity is an electrical hold off on that as well in terms of the drawdown in March we're probably not going to give you any specific numbers in terms of runway and what that provides credit if you can address that Justin.

Justin A. Renz: Mmm. Thank you <unk>. Thank you Mike.

Justin A. Renz: You know, we are overall starting to move towards what we'll call steady state spending. So this drawdown, of course, we're very mindful of how we bring in additional capital. We try to be thoughtful and measured in how we approach our spending and our planning. And so, on top of the $184.3 million we had at the end of the year, then this really does put us in good shape.

Speaker Change:

Speaker Change: Overall stirring the move towards.

Justin A. Renz: Did he state spending so distraught and of course, we're very mindful of how we.

Justin A. Renz: Bring in additional capital and we try to be thoughtful and measured how we approach our spending planning and so on top of the 184.3 million. We added the end of the year and it's really does.

Justin A. Renz: And, you know, we are obviously always trying to balance the need to fund our operations with other considerations. So, you know, for us, we're taking it, you know, thoughtfully and measured. And, you know, we mentioned the increased activities we look to add to the commercial team this year. And once we get into steady state, as I mentioned, we'll be able to give you a more precise number. We're not really positioned to give you an exact date now, other than that we're in really good shape.

Justin A. Renz: What is in good shape and you know we are obviously always trying to balance need are funnier operations with other considerations.

Justin A. Renz: So.

Justin A. Renz: For US you know, we're we're taking it you know.

Justin A. Renz: Sweet and measured we mentioned the increased activity so we want to.

Justin A. Renz: Two.

Justin A. Renz: Add to the.

Justin A. Renz: Team this year.

Justin A. Renz: Did you get the city state as I mentioned.

Justin A. Renz: You'll be able to give you more precise number or not.

Justin A. Renz: 19 now.

Justin A. Renz: Really good shape.

Operator: Okay, thank you. The next question comes from Yigal Nochomovitz from Citi; please go ahead. Hi, Mike and team.

Speaker Change: Okay. Thank you.

Speaker Change: The next question comes from from your golf not Gonna move it from city. Please go ahead.

Speaker Change: Hi, I can see them. Thank you on the on the observational trial that you've talked about can you just talk a little bit more is that is there a fixed number of patients that can enroll or is it more open ended will the patience that go into that trial be getting free drug are they still considered commercial patience.

Dr. Laura Williams: Thank you. On the observational trial that you talked about, can you just talk a little bit more? Is there a fixed number of patients that can be enrolled, or is it more open-ended? Will the patients that go into that trial be getting free drugs, or are they still considered commercial patients? And also, you obviously had approval back in October. Just curious as to why the study is starting now versus right after when the drug was approved. Laura

Speaker Change: And also just no you obviously had approval back in October just curious as to why the study starting now versus you know right. After when the when the drug was approved.

Speaker Change: Laura.

Dr. Laura Williams: Yeah, sure. I mean, thanks, Yigal. I mean, the first question in terms of the number of patients is more open. I mean, obviously, it's a real world study where, again, we're looking at patients who are being prescribed the drug in a real world clinical setting. And so it's not a free drug.

Speaker Change: Yeah sure I mean.

Laura Williams: Thanks, you go I mean, the first question in terms of the number of patients. It is neither open I mean, obviously, it's it's a real world you know study where again, we're looking at patients Oh, who are being prescribed the drug in a real world clinical setting and so it's not free.

Dr. Laura Williams: It's basically patients who are, again, either intolerant to phosphate binders or, you know, have not gotten to their treatment goal on binders alone. And so it's more of an open sort of enrollment piece. But again, the investigators that, you know, are looking to enroll patients will, you know, make that decision based on, you know, the normal shared decision making between, you know, patients and physicians. And Yigal, to address your question about whether commencement is, you know, it takes time to get these things going and figure out which investigators we'll work with. So, nothing about that time frame that might be relevant. Okay, and then I was doing some math on the guidance, so 140 to 150 works out to 9% to 12% quarter-on-quarter growth, so just curious about how you arrived at that. And then, actually, if you carry that out into the future, and then you look at what happened with LINZES. LINZES was launched in December 2012, it got to a billion in 2021, it took nine years. If you take the low end of your guidance quarterly, quarter-on-quarter, you will get to a billion in, I guess, somewhere around 2029 or 2030.

Laura Williams: Drug it's basically patient too alright, again are you know either intolerant to phosphate binder.

Laura Williams: You know have not gotten to their treatment goals on binders alone. So it's more of an open open sort of enrollment piece, but again the the investigators that you know are looking to enroll patients Bill you know make that decision based on.

Laura Williams:

Laura Williams: Shared decision, making between patients and physicians.

Laura Williams: I'll take the rest of your question about.

Laura Williams: <unk> is it takes a lot to get these things growing and figuring out which investigators will work with so nothing.

Laura Williams: That time frame that right relevant.

Speaker Change: Okay, and then I was doing some math on the guidance. So 140 to 150 works out to 9% to 12% quarter on quarter growth. So just curious about how you arrived at that and then F. Actually if you carry that out into the future and then you look at what happened with Linzess Linzess.

Speaker Change: It launched December 2012, I got to 1 billion in 2021. It took nine years. If you take the low end of your guidance quarterly quarter on quarter, you will get to a billion and I guess 20th somewhere around 2029 2030.

Michael G. Raab: So, just curious what you think about that timetable. Well, I think your math is very good, but, you know, what we've said is that we see this as a billion-dollar opportunity. We haven't given a time frame within which we will accomplish that.

Speaker Change: So just curious what what do you think about that that time time that timetable.

Speaker Change: Well I think your math is very good [laughter], but you know what.

Speaker Change: What we said is that we see this as a billion dollar opportunity we haven't given the time frame with a <unk> with a <unk>.

Speaker Change: Within which we will accomplish that.

Michael G. Raab: You know, I think, I hope, what you've learned about us, we're very measured in the way that we do this, and certainly, if we see opportunity to give you more specificity around the time frame of hitting those numbers, we will. But we're very confident with what we've guided for this year, between 140 and 150. Certainly gets us on the kind of trajectory you just described. Okay, great, thank you.

Speaker Change: I think I hope with what you've learned about us, we're very measured and the way that we do this and certainly if we see opportunity to give you more specificity around the time frame of hitting those numbers, we will but we're very confident with what we've got it for this year between 140 150, certainly get this on the.

Speaker Change: Kind of project that you just described.

Speaker Change: Okay, great. Thank you.

Operator: The next question comes from Ryan Deschner of Raymond James. Please go ahead. Hi there.

Speaker Change: The next question comes from Ryan Desk Deschner have Raymond James. Please go ahead.

Ryan Deschner: Hi, there.

Michael G. Raab: My question is, you know, from our recent discussions with nephrologists over the last few weeks, we're hearing a heavy interest in the perceived compliance benefit associated with EXPOSA for patient subpopulations, actually both with and without adequately controlled serum phosphorus. So my questions are, how big of a market segment is represented by patients who are failing phosphate binders largely due to poor compliance? And how are you thinking about potentially addressing the market segment represented by patients with controlled serum phosphorus who have a strong desire to reduce pill burden in the future? Yeah, I mean, I'll let Susan address some of this too, but that second population, you know, that falls potentially within a definition of intolerant, right?

Ryan Deschner: My question is.

Speaker Change: You know from a recent discussions with Nephrologist over the last few weeks, we're hearing a heavy interest actually in the perceived compliant benefit associated with exposure.

Speaker Change: For patient populations.

Speaker Change: Actually both with and without adequately controlled seem phosphorous. So so my questions are how.

Speaker Change: How big of a market segment is represented by patients who are failing phosphate binders largely due to poor compliant.

Speaker Change: And how are you thinking about potentially addressing the market segment represented by patients with controls here in phosphorous, who have strong desire.

Speaker Change: To reduce pill burden you know in the in the future.

Speaker Change: Yeah, I mean, I I <unk>, Susan to address some of this too but.

Speaker Change: That's second population that false attempt to you within a definition of intolerance alright. If you think about how these patients have had to take these handfuls of pills.

Michael G. Raab: If you think about how these patients have had to take these handfuls of pills every day, multiple meals, every meal and snack, that's a tolerance issue, not necessarily an efficacy issue. So, we think that the indication that we were ultimately able to get from the FDA allows a physician to attest to either one, and anything else to add. Yeah, I would just add that consistently, we see approximately 70% of patients, despite treatment with binders, are unable to achieve or maintain the global guideline target levels within a six-month period. And what we're finding now on the market in front of nephrologists is that they believe that the majority of their patients are unable to achieve or maintain target levels with binder therapy.

Speaker Change: Every day multiple meals every meal and snack that's a tolerance issue not necessarily an advocacy issue. So we think that the indication that we were ultimately able to get from the F. D. A allows a physician to a test to either one of those too.

Susan: Susan anything to add.

Susan: Yeah, I would just add that it's really important to note that consistent really see approximately 70% of patients. Despite treatment with binders are unable to achieve or maintain the global guideline target levels within a six month period, so and what we're finding now.

Susan: On the market in front of Nephrologist is that they believe that the majority of their patients are unable to achieve or maintain target levels with finger therapy. So that the population that you know of lines of their indication is really quite large and I think you know, it's and that's why we're seeing the enthusiasm on the part of the nephrology community and.

Michael G. Raab: The population that aligns with our indication is really quite large, and that's why we're seeing the enthusiasm on the part of the nephrology community to now finally have another option for those patients. And with the novel mechanism of EXPOSE as a first-in-class phosphate absorption inhibitor, there's broad application for those patients that are inadequately managed despite binder therapy.

Susan: Now finally have another option for those stations and with the novel mechanism of exposure as the first in class Birthdate absorption inhibitor. You know there's broad application to be used for those patients that are you know <unk> inadequate Lee managed despite binder therapy on top of that the intolerance consideration you know it was another opportunity for you to the <unk>.

Susan Rodriguez: On top of that, the intolerance consideration is another opportunity for the use of EXPOSE. Clearly, the compliance benefit is something that people speak of. I mean, one small pill twice a day, especially if it's being added to a therapy regimen, patients are responding really favorably, like, "Wow, I could take this." Or if the physician decides to discontinue the binders, now they're on one pill twice a day.

Susan: Those are so.

Susan: Clearly the compliance benefit is something that people speak to mean, one small pill twice a day you know, especially if it's being added to a therapy resident you know the patients are responding really favorably like Wow I can take this or if the physician decides to just continue to find you. Another round one pill twice a day, yeah, that's really resonating with <unk> with.

Susan Rodriguez: Yeah, that's really resonating with physicians and with patients, and it's really part of the momentum driving the use of Exposa, and ultimately, compliance is so intermingled with why patients have been unable to reach target levels. So we're quite confident that there's a really strong opportunity within the labeled claim, and we're seeing that in the enthusiasm in the marketplace. Thanks so much.

Susan: Physicians and with patience and it's really part of the momentum driving the use of <unk> and ultimately the complaint is so intermingled with why patients had been unable to reach target level. So uhm. So we're quite confident that there is a really strong opportunity within the label claim.

Susan: And we're seeing that any enthusiasm in the marketplace.

Speaker Change: Thanks, so much appreciate it.

Operator: I appreciate it. The next question comes from Joseph Tomee from TD Cowan. Please go ahead. Hi there, good afternoon.

Speaker Change: The next question comes quite Joseph Tomey from T. D. Cowan. Please go ahead.

Joseph Tomey: Hi, there good afternoon, congrats on the progress and thank you for taking my questions I have one on expose them they'll have a follow up on it was wrong. It if possible, but maybe first son expose or are you able to provide any sort of information on the number of prescribers that of maybe written since lunch or I guess, if you can going forward what sort of metrics do you anticipate provide.

Michael G. Raab: Congratulations on the progress, and thank you for taking my questions. I have one on Xposa, and I'll have a follow-up on Ivazuela if possible. But maybe first on Xposa, are you able to provide any sort of information on the number of prescribers that have maybe written since launch? Or, if you can, going forward, what sort of metrics do you anticipate providing to kind of gauge how the launch is progressing? And then I'll have a follow-up. Hey, Joe, thanks for the question. You know, obviously, an understandable question given some of the data that you're accustomed to isn't available. But, you know, we're not going to be in a position to count physicians and do that.

Joseph Tomey: <unk> to kind of gauge our lunches progressing uhm and they don't have a whole lot.

Speaker Change: Hey, Joe Thanks for the question you know obviously.

Joe: Understandable question, given some of the data that you're accustomed to isn't available, but you know we're not going to be in a position to help physicians and do that I think the as we begin as you did withdrawal getting the comfort of a number of quarters underneath our belt ultimately the revenue guidance that we are going to <unk>.

Michael G. Raab: I think that as we begin, as we did with Adrela, getting the comfort of, you know, a number of quarters underneath our belts, ultimately, the revenue guidance that we are going to give is going to be the most important thing for all of you to follow. And, you know, presumably, there will be some resolution as to how you can access script data, whether it's through outlets like you have in the past or acquiring that data as well. And what's your question about Adrela? And then at Ibrazuela, I had a question about our ally study, phase three in pediatric patients with IBSC. I guess how important the data from this study is? How is this progressing? And when you think about that expanded $1 billion market opportunity, does that include patients, or a meaningful number of patients at all under age 18? Or would this be an expansion of that number if you're able to kind of get that on a label?

Joe: That's gonna be the most important thing for all of you to follow and.

Joe: And presumably there will be some resolution as to how you can access script data, whether it's through Oh. It looks like you have in the past recording this data as well and what's your question on Ms. Rowling.

Joe: And then it was <unk> I had a question on the R. L. I study the the phase three in pediatric patients with Ivy S. C. I guess, how important our data from from this study kind of how is this progressing and when you think about that extended 1 billion dollar market opportunity does that include patients or meaningful number of patients at all.

Joe: All under age 18 or would this be an expansion to that number if you're if you're able to kind of get that on the label. Thanks Yeah.

Dr. Laura Williams: Yeah, I think very basically it'd be an expansion, but Laura, if you want to address the question about the trial, yeah, in terms of the pediatric study, I mean, again, we've got an ongoing study in patients who are aged 12 to 18, and that study is progressing nicely. And we have another study that is planned in pediatric patients age 6 to 11. So, in terms of those studies, we see them progressing as planned. In terms of, you know, Mike, maybe you want to address the other part of the question in relationship to how that, you know, pertains to additional revenue. Yeah, you know, there's obviously a population there that we would that would benefit from a product like Adrela. You know, quantifying that it's gonna is not something that we've done, but it's potentially something that we would think is an expansion. Great, thank you very much.

Speaker Change: I think very basically it'd be an expansion, but uhm Laura if you wanted to address the question about the cough.

Laura Williams: Yeah in terms of the the Paediatric study I mean again, we've got an ongoing study in patients who are aged 12 to 18 in that study is progressing nicely.

Laura Williams: And we have another study that is planned in in pediatric patients 862, 11, uhm. So in terms of those those studies.

Laura Williams: We we we see them progressing is.

Laura Williams: <unk> in terms of.

Laura Williams: You know might maybe you wanted to address the other part of the question in relationship to how bad.

Laura Williams: You know pertains to additional revenue.

Speaker Change: Yeah, you know cause obviously, a population there that we would that would benefit from a product like a thriller.

Speaker Change: Quantifying that it's gonna, it's not something that we've done but is potentially.

Speaker Change: Something that we would think of as an expansion.

Speaker Change: Great. Thank you very much.

Speaker Change: The next question comes from Ed R. C from H C. Wainwright. Please go ahead.

Operator: The next question comes from Ed Arce from A.C. Wainwright. Please go ahead. Hi, good afternoon.

Speaker Change: Hi, Good afternoon. This is Thomas Yeah, it's asking a couple questions. Thank you for taking my questions Uhm. So first it's Lola.

Operator: This is Thomas Yip asking questions. Thank you for the kind words. So first on Israel, can you provide some details on a plan that was previously announced to expand US Salesforce, both in terms of scale and timing of the increase? Should we expect an incremental increase throughout the year? Or is it contingent on certain criteria for expansion?

Thomas: Can you put by some details on.

Thomas: <unk> <unk> to expand yourself spores, both of them chocolate and cancel scale and sign me up the increase should expect an incremental increase throughout the year or is it contingent on seven criteria for extension.

Michael G. Raab: Yeah, I think, as you heard in our opening comments, we're taking the Israel dedicated team from 64 to 125. And as Justin said in his commentary, steady state spend on that we expect would be in, evidenced by the third quarter. Right. Got it.

Speaker Change: Yeah, I think as you heard in our opening comments were taking the it's relic dedicated team from 64, Uhm 224, and as Justin said in his commentary steady state spend on that we expect would be and.

Speaker Change: Evidenced by the third quarter of this year.

Speaker Change: Okay got it. Thank you and then perhaps one more question on exposure.

Michael G. Raab: And then perhaps one more question on exposure. When should we expect the first time to go buy revenue guidance?

Speaker Change: Should we <unk>, we expect first time to provide revenue guidance should we expect something along the line <unk>.

Michael G. Raab: Should we expect something along the line, probably two hours, you know, in other words, about 12 months of sales before we see guidance? Yeah, I mean, I think that's prudent when we see, you know, in some of the questions on this call, what the impact is of seasonality, the first quarter, all those things. You know, with Azrela, it was, you know, four, four and a half, five quarters under our belt before we came out with any guidance. All right, sounds good. Thank you again for your questions. First,

Speaker Change: You know in other words about 12 months of sales before we see a guidance.

Speaker Change: Yeah, I mean, I I think that's prudent let me see some of the questions on this call what the impact is of seasonality of the first quarter. All those things you have withdrawal. It was four four and a half five quarters underneath our belt before.

Speaker Change: We came out with any guidance.

Speaker Change: Alright sounds good. Thank you can put your questions.

Operator: The next question comes from Matt Kaplan from Lautenberg Thalmann. Please go ahead. Hey, guys. Thanks for taking the questions. I just wanted to stick with Ebsrella for a minute.

Speaker Change: Of course, thank you.

Speaker Change: The next question comes from Matt Caplan, Some Latin embarks Tillman. Please go ahead.

Matt Caplan: Hey, guys. Thanks for taking my questions.

Matt Caplan: Just wanted to stick on <unk> for a minute what are you seeing I guess for a trailer with respect to to use in terms of duration on therapy.

Susan Rodriguez: What are you seeing, I guess, for Ebsrella with respect to its use in terms of duration on therapy? And are our patients using it in a cyclical fashion? Kind of come on and come off the drug. Yes, Susan, you want to address that? Sure, yes, Matt.

Matt Caplan: Our patients using it in a in a cyclical fashion kind of come on come off the drug.

S: S. As in you want address that.

Speaker Change: Sure, Yes, Matt So what were you know the feedback that we're getting from the.

Susan Rodriguez: So what we're, you know, the feedback that we're getting from physicians treating patients with Ibserella is really highly favorable in terms of patient response to therapy and satisfaction with therapy. Overall, we're finding that, as you have noted, IBSC patients overall, when they're feeling better, tend to want to maybe stop taking the drug, knowing that if the symptoms come back, they would reinitiate therapy. So, at this point, we're finding that overall behavior is probably consistent, regardless of the treatments that are prescribed. But the good news from the marketplace is that physicians are keeping them on the drug and really believe that the drug is working. And then with respect to Exposa, what are you seeing in terms of the current mixture of patients on Exposa in terms of using it in a combo setting versus monotherapy, and I guess how do you think that will evolve over time? I'm not sure we have an exact answer.

Matt Caplan: Physicians treating patients with it it's really it's really highly favorable in terms of the patient responds to therapy, uhm and satisfaction with therapy. Overall, we're finding that as you have noted Ivy S. C patients overall, when they're feeling better tend to want to maybe stop taking the drive knowing.

Susan: That if the symptoms come back they would reinitiate therapy. So at this point, we're finding that that overall behavior is probably consistent regardless of the treatments that are prescribed them, but the good you know the good news from the market places that position you know are keeping them on the drug and really believe that the drug is working.

Speaker Change: Okay. That's helpful.

Speaker Change: And then with respect to.

Speaker Change: <unk> what are you seeing in terms of the current mixture of patients monarch Sosa in terms of using it in combo setting versus a mono therapy.

Susan Rodriguez: I guess, how would you how do you think that Ah falls over time.

Speaker Change: Yeah, I'm not sure we have exact visit.

Susan Rodriguez: Visibility into other prescriptions. Right, so we have a closed system with our adults assist program that helps with the prior authorization process. Susan, do we have an opinion on that? Yeah, actually it's a great question, Matt.

Ryan Deschner: Visibility into other prescriptions right. So this is a we have a closed system with our our dealt with this program that helps.

Speaker Change: Prior authorization process, Susan do we have perspective on that.

Susan Rodriguez: Yeah actually it's a great question, Max I think that there isn't a quantitative answer but what we can say is based on our experience now in the opposite that we're seeing physician, adding exposure to the current regimen and seeing a nice response in phosphorus reduction we're seeing patients.

Susan Rodriguez: So I think that there isn't a quantitative answer, but what we could say is, based on our experience now in the offices, that we're seeing physicians adding Exposa to the current regimen and seeing a nice response in phosphorus reduction. We're seeing patients reducing the binder dose and adding Exposa and also having a favorable experience, and we're seeing physicians just eliminate the binders and initiate the use of Exposa and seeing a response, and then potentially adding back the binder if they need it. So early in the launch, what we're finding is that because of the novel phosphate blocking mechanism and one small pill twice a day, it really gives the physician a lot of flexibility in terms of how to use the product, and then overall, they're telling us that the patients are responding favorably and are satisfied, and they're seeing reductions in phosphorus levels. So it's all very encouraging. Over time, we'll do our own, you know, as we contract this out in market research, but it would have to be custom work. It's not really something available through the script data,

Speaker Change: Do you think the binder, Dallas, and adding exposure and also having a favorable experience and we're seeing physicians.

Speaker Change: Eliminate the binders and initiate you said expose that and seeing a restaurant Dorothy and then potentially adding back the binder if they need it. So so I think early in the lines. What we're finding is that because of the novel you know phosphate blocking mechanism and one small pill twice a day it really gets the physician a lot of flexibility and.

Susan Rodriguez: <unk> and how to use the product and then overall, they're telling us that the patients are responding favorably and satisfied and they're seeing reductions in phosphorus level. So so it's all very encouraging over time, we'll do our own you know as we can track. This in market research. It would have to be custom work, it's not really something available through the script.

Michael G. Raab: You know, we'll have a better understanding of how that cuts, but overall, it really just leads to a broad base of use and seeing Exposa as applicable to a broad range of patients and that they can customize. And Matt, I think that's why we're referring to this as an EXPOSA-based regimen, because it allows the flexibility for clinicians to do exactly what Susan just described. Well, congratulations on the progress and thanks for taking the question. This concludes our question and answer session. I would like to turn the conference back over to Ardelyx President and CEO, Mike Raab, for closing remarks. Thank you, everyone, for joining us this evening, and especially to those many shareholders who've been on this wild ride with us, whether for the past few years, the past few months, or even the past few weeks.

Susan Rodriguez: Data you know, we'll have a better understanding on how that Cox, but overall it really just leads to a broad based <unk> and seeing expose is applicable to a broad range of patience and that they can customize.

Michael G. Raab: Okay Yep <unk>, that's why we refer while we're referring to this isn't it expose it based regimen is it allows the flexibility for connections to do exactly what Susan just described.

Michael G. Raab: Mmm.

Michael G. Raab: Well congrats on the progress and thanks for taking my questions.

Matt: Thanks Man.

Michael G. Raab: This concludes that question and answer session I would like to turn the conference back over to our <unk>, President and CEO micro Rob for closing remarks.

Michael G. Raab: Thank you everyone for joining us this evening and especially to those many shareholders who've been on this wild drive with us whether for the past few years the <unk>.

Michael G. Raab: Past few months or even the past few weeks I hope that what you've seen and heard from US today is that we were thoughtful and measured and how we build our business that we focused on executing on our priorities and then we have the right team in place and to that team <unk> I would like to extend a special and heartfelt. Thanks to all of you for what you do everyday to further our efforts to.

Michael G. Raab: I hope that what you've seen and heard from us today is that we are thoughtful and measured in how we build our business, that we focus on executing on our priorities, and that we have the right team. And to that team, Team Ardelyx, I would like to extend a special and heartfelt thanks to all of you for what you do every day to further our efforts to deliver on our mission, and, most importantly, to support. With that, we can close the call. Thank you, Danielle. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Michael G. Raab: Deliver on our mission and most importantly to support patients with that we can close the call. Thank you Daniel.

Michael G. Raab: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.