Ardelyx, Inc. Q1 FY2022 Earnings Call

Good afternoon and welcome to Ardelyx's First Quarter 2022 Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session after the prepared remarks. As a reminder, today's call is being recorded. I would now like to turn the call over to Justin Renz, Chief Financial Officer of Ardelyx. You may now begin.

Thank you and good afternoon, everyone and welcome to our first quarter financial results call. During this call, we will refer to the press release we issued earlier today, which is available in the Investors section of the company's website at ardelyx.com. On the call with me today with prepared remarks are Mike Raab, President and CEO; and Susan Rodriguez, Chief Commercial Officer; Dr. Laura Williams, Chief Medical Officer; Dr. David Rosenbaum, Chief Development Officer; and Rob Blanks, Chief Regulatory Affairs and Quality Assurance Officer, who will join us for the question-and-answer period. 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. We encourage you to review our risk factors in our quarterly report filed on Form 10-Q earlier today, which can also be found on our website at ardelyx.com. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so even if our views change. With that, let me pass the call over to Mike.

Thank you, Justin and good afternoon, everyone. We're thrilled to provide you an update on what has been a highly productive quarter filled with positive developments on multiple fronts. 2022 is off to a great start. IBSRELA launches underway and progressing well after just a few weeks on the market and for XPHOZAH we welcome the news from the FDA that an advisory committee will be convened to review and advise on the clinical meaningfulness of our data. These are important catalysts which have the potential to significantly build shareholder value in 2022. The most significant driver of value growth for Ardelyx is in our anticipated success and commercialization of IBSRELA. Indeed. This is a remarkable time for the company as we now are seeing the results of years of research for our internally discovered and developed drug candidate, transformed into a promising new therapeutic that is now in the hands of pharmacies and patients. It is with great confidence that the torch so to speak has passed to our highly capable and talented commercial team led by Susan Rodriguez. In the initial days of launch, I had the pleasure of going into the field and observing firsthand not only the skill and professionalism of our sales team, but also the physician receptivity and excitement as they gain awareness of IBSRELA. I've asked Susan to later on the call provide a robust update on the progress we've made since our official launch of IBSRELA on April 4th of this year. We can say that my observations thus far are consistent with the market research that Susan and her team have conducted regarding the need and attractiveness of a new therapy like IBSRELA. Turning out briefly to XPHOZAH. I'd like to review where we stand in regards to our formal dispute resolution efforts. At the end of April, Dr. Stein, the Director of the Office of New Drugs, Center for Drug Evaluation Research of the FDA, provided an interim response to a second level of appeal for the complete response letter for XPHOZAH, in which he indicated the need to convene the Cardiovascular and Renal Drug Advisory Committee augmented with expert clinicians to gain additional insights into the clinical meaningfulness of the phosphate-lowering effect observed in our Phase 3 clinical program for XPHOZAH. We welcome this advisory panel, as it will allow for Dr. Stein to receive input from treating clinicians in order to understand their perspective of the clinical meaningfulness and significance of the phosphate reduction we have demonstrated with XPHOZAH. We are confident in the nephrology community’s belief in the novel mechanism of action of XPHOZAH and the important role that it can play in addressing a critical unmet medical need in the management of hyperphosphatemia. We await direction from Dr. Stein on the timing of this meeting, and look forward to the discussion. Turning to RDX013. We completed our analysis of the safety and efficacy from our Phase 2 dose-ranging trial for RDX013 for the treatment of hyperkalemia in chronic kidney disease patients who are not on dialysis. While the results of the study demonstrated an acceptable safety and tolerability profile for RDX013, and supported an important proof-of-concept in its ability to lower serum potassium levels with statistically significant results compared to placebo. After eight days of treatment, the study did not meet its primary endpoint of significantly reducing serum potassium levels compared to placebo after four weeks of treatment. When appropriate, the next steps for the program will be to continue work on new formulations and to evaluate the efficacy of RDX013 in a future Phase 2 study. In April, we were pleased to announce that we had reached an agreement with our Japanese partner, KKC, to amend our license agreement, providing us the potential for important near-term non-dilutive capital. As we announced in April, in consideration for a reduction in the royalty rate due to Ardelyx upon net sales in Japan, KKC will pay us up to an additional $40 million payable in two tranches. The first following their filing of tenapanor for marketing approval in Japan and the second payment due following the approval to market tenapanor for hyperphosphatemia in Japan. KKC is finalizing the Phase 3 clinical program for tenapanor for hyperphosphatemia and has disclosed its current expectation to file for marketing approval within the second half of this year, and a current expectation that would receive the decision regarding this application in the second half of 2023. In summary, as we kicked off 2022 with the launch of IBSRELA and now is a revenue-generating company, with the opportunity to support clinical meaningfulness of our clinical data for XPHOZAH at an advisory committee, a pipeline of internally discovered drug candidates and a strengthening cash position. We see IBSRELA as a highly differentiated company in our industry, uniquely positioned for success with dedicated, talented teams across the company. Now, I'd like to pass the call to Susan to provide a commercial update on the launch of IBSRELA. Susan?

Thanks Mike. I echo Mike's sentiments about our strong start to 2022. We've launched IBSRELA, our first-in-class novel mechanism therapy for the treatment of Irritable Bowel Syndrome with constipation (IBS-C) in adults, with initial stocking and the Salesforce mobilized across the country. Commercial efforts are focused on the 9,000 HCPs who account for approximately 50% of the prescriptions written for IBS-C indicated products, with broad-based product distribution, a targeted specialty Salesforce and omnichannel tactics. Marketing messages center on the multifactorial pathophysiology of IBS-C and the role the novel triple action mechanism of IBSRELA can play to address important medical unmet needs. Revenue reported in Q1 reflects some of the initial stocking of IBSRELA in advance of our April 4th commercial launch. Early market response has been favorable. Interest across our gastroenterology targets is high, with our Salesforce team given quality time to review the novel product profile and robust clinical data for IBSRELA. HCPs express the need for expanded options to treat IBS-C, respond favorably to the information presented on IBSRELA and share that there are many patients that they believe can benefit from a novel mechanism approach. A foundation of use for IBSRELA is being built. The market environment we are launching into is favorable. The market-building investments linked to the introduction of GCC agonists over the past decade have transformed the management of IBS-C converting what was once an OTC market to an established prescription therapy market consolidated largely around two branded therapies with a concentration of high writing HCPs. Within the context of this established prescription market, these HCPs persistently report that approximately a third of patients under their care continue to have symptoms and are considered to be inadequately managed. This relatively uncluttered market with conditions that enable a targeted approach with a stated need for expanded therapeutic options is an ideal opportunity for IBSRELA with its differentiated first-in-class mechanism and compelling clinical profile. Our research indicates that 56% of high prescribers consider IBS-C a difficult condition to treat, and 83% reported that there was a significant unmet need in the treatment of IBS-C. 75% of these high prescribers reported a favorable response to the IBSRELA profile, rating its novel mechanism and efficacy data as the most compelling attributes and projected use of IBSRELA in a meaningful subset of their patients. While we're still in the early weeks of launch, HCP response on the ground aligns with these research findings. We are positioning IBSRELA as a first-in-class NHE3 inhibitor with a triple action in treating IBS-C. We are emphasizing the novel mechanism of IBSRELA as differentiated from existing therapies. With clinical data that demonstrates significant improvement in abdominal pain, bloating and constipation, with a quick onset of action, sustained efficacy and an acceptable safety and tolerability profile. Our physician education is also centered around clinical results, demonstrating improved patient quality of life versus placebo and patient-reported treatment satisfaction. Our objective is to establish IBSRELA with its new mechanistic approach and triple acting effect as a meaningful new treatment option for HCPs who treat patients with IBS-C. Our Salesforce efforts targeted at the highest writers will be further amplified by omnichannel tactics, leveraging the rapidly advancing dynamics in the marketplace on how and where HCPs receive their information. Our distribution network is another key element to our commercial strategy, which includes both retail and specialty channels to accommodate office and patient preferences and align to their existing processes for handling specialty products. As the launch progresses, I'd like to reiterate what to expect. Patient access is key to market traction. As a novel product, our access strategy is centered on the value proposition of addressing the existing clinical unmet needs among actively treated patients. We will not rebate to match existing agents, but instead we'll work with payers to minimize the step-through requirements. From a payer landscape perspective, prior authorization and step therapy protocols for novel entrants are standard for this market today. HCPs have to attest to the fact that patients have been on lower agents, yet their condition persists and are considered to be inadequately managed. We consider these access challenges to be addressable on the basis of four key considerations. One, the patient need for IBSRELA for a condition with limited treatment options; two, HCP demand for IBSRELA and willingness to support the prior authorization requirements; three, the HCP familiarity and experience in addressing these requirements implicit in the space; and four, the comprehensive customer service support we will have in place to support physician offices. In parallel, we will work with payers to secure access and minimize step therapy requirements. Market penetration with IBSRELA will be enabled by the existing pool of IBS-C patients that are in need of a novel mechanism therapy and considered good candidates for treatment with IBSRELA, counterbalanced by access ramp-up challenges and the need for HCPs to work through the expected payer hurdles as I noted earlier. With a targeted specialty Salesforce, full company engagement and innovative omnichannel peer-to-peer and digital initiatives, we will bring IBSRELA to the patients being actively managed today, who are in need of additional treatment options. IBSRELA will have a strong commercial and clinical presence at the largest annual GI conference, Digestive Disease Week, taking place May 21st to the 24th in San Diego. We plan to leverage this conference as a major launch initiative. Our commercial initiatives and market receptivity are proceeding as anticipated. Gastroenterologists are responding favorably to the IBSRELA mechanism and clinical profile. They are enthusiastic to have a new addition to their treatment armamentarium and have patients in mind that can benefit from IBSRELA. They anticipate prior authorization requirements and are motivated to utilize the structures and processes they have in place in their offices to work through access hurdles, in many cases, in partnership with specialty pharmacies or through our Ardelyx assist patient services program. Prescriptions are being written and filled. We are thrilled to bring this much-needed, highly differentiated therapy to market, and most importantly, to make a difference in the lives of patients who are suffering from IBS-C. I will now turn the call over to Justin to review our Q1, 2022 financials. Justin?

Thank you, Susan. At the end of the first quarter 2022, we had total cash, cash equivalents and short-term investments of $89.7 million as compared to total cash, cash equivalents and investments of $116.7 million as of December 31st, 2021. As we just discussed, we recognized our first commercial product sales from initial IBSRELA stocking in March of approximately $0.5 million. Research and development expenses were $8.9 million for the quarter ended March 31st, 2022, a decrease of $11.6 million or 57% compared to $20.5 million for the same quarter last year. The decrease in our R&D expenses is primarily the result of lower clinical study costs from the optimized study, lowered abnormal manufacturing expenses, as we've begun to capitalize costs associated with the IBSRELA inventory, and lower expenses following the elimination of our research function in the fourth quarter of 2021. Selling, general and administrative expenses were $19.3 million for the quarter ended March 31st, 2022, an increase of $2.2 million or 13% compared to $17.1 million for the same quarter last year. The increase in SG&A expenses was primarily due to an increase in costs associated with preparation for the commercial launch of IBSRELA. Our net loss for the quarter ended March 31st, 2022 was $28.1 million or $0.21 per share compared to $33.2 million or $0.34 per share for the same quarter last year. It is important for us to bolster our cash position, and we will continue to pursue and evaluate a number of opportunities, including non-dilutive measures, such as commercial sales of IBSRELA, milestone payments from our partners, as well as judicious cash management. Along those lines, during Q1, we prudently took advantage of our ATM raising $6 million of proceeds from equity sales under the program. As Mike mentioned earlier, in April we announced we'd amended our licensed agreement with KKC. In consideration for a reduction in future royalties upon net sales in Japan, KKC agreed to pay our debt consideration of up to an additional $40 million. KKC reported their Q1, 2022 results earlier this week. And they noted that they remain on track to file their NDA for tenapanor for hyperphosphatemia in Japan in the second half of this year, which in addition to the proceeds we would receive under our recent amendment would also trigger a significant regulatory milestone payment to Ardelyx under our original license agreement. We will continue to actively pursue other non-equity solutions to extend our cash runway further into 2023. We have confidence in our ability to continue to fund our operation. I will now turn the call back to Mike for some concluding comments before we take some questions. Mike?

Thanks Justin. And before I open the call, I want to emphasize a couple of points. We look forward to making a case for XPHOZAH to the FDA's advisory committee in the coming months, as we believe it will be an essential treatment for patients on dialysis with hyperphosphatemia. And although we are just over a month into the launch, we like the positive response we hear from the field for IBSRELA and the role that it can play in treating patients with IBS-C. Susan has built a spectacular commercial team and they're laser-focused on successful execution, working to gain meaningful market share. The opportunity for us with IBSRELA is significant, as it provides a clear line of sight to financial breakeven. Finally, this is an exciting and truly transformational time for Ardelyx, and we are becoming an impressive growth story with lots of opportunities ahead. It's really important to note our internally discovered pipeline has fueled diversification and critical optionality and has positioned us well for near-term and long-term future growth. We look forward to keeping you apprised of our progress. And with that, I will now open the call to questions. Debbie?

We will now begin the question-and-answer session. The first question is from Chris Howerton with Jeffrey. Please go ahead.

Excellent. Thank you so much. Excellent news on the advisory committee update and thanks for taking the questions team. So, I guess, maybe, what I'll start off by with respect to the advisory committee for XPHOZAH. I think, Mike, you had mentioned that you're expecting within the coming months, be curious to hear, if you could articulate, just give us a little color on your thinking on the timing of that. Also as it relates to the advisory committee, do you anticipate providing any additional information to the FDA prior to that outside of just the standard briefing documents? And if I may, as a third part of that question would be, what is the significance of patient advocacy groups in your argumentation in discussing the clinical meaningfulness of XPHOZAH? Thank you.

Thank you, Chris, for your questions. We haven't received a response from Dr. Stein's office yet, but once we do, we will share that important update. We expect to hear back soon and believe we will have more than three months to prepare. We are already working full-time on multiple tasks to ensure we are ready for the Advisory Committee meeting. Regarding your second question, no new data will be submitted. We will present our briefing book and can only use the data submitted as part of our NDA, which includes all our clinical work and the entire Phase 3 program. We have substantial data to work with that we have discussed since receiving the Complete Response Letter over a year ago, and we feel confident in the strength of this data as we prepare for the meeting. Patient and Key Opinion Leader advocacy is crucial for us. We have been in contact with patients and physicians who have expressed their eagerness to share their thoughts on the importance of XPHOZAH and its ability to block phosphorus compared to existing medications. This collaboration with the patient and KOL community will be a vital element of our approach.

That's excellent that you've been given that opportunity. I'm really looking forward to that. If I could sneak in one more question, Susan, regarding the launch of IBSRELA, what is your position on using sampling or other methodologies to increase demand?

Thanks for the question, Chris. We have found that gastroenterologists we work with typically sample patients, especially when starting a new therapy, to evaluate their response early on. Based on that response, they proceed with prescriptions and managing prior authorization requirements for a specialty drug like IBSRELA. Sampling is definitely a part of our strategy, but we are practical about ensuring samples reach high prescribers to help them begin treatment with new patients without disrupting the product's ramp-up. The demand for prescriptions is crucial to our growth as it helps demonstrate demand from top gastroenterologists to the payers while we work to secure access for IBSRELA.

Okay. Well, that's very clear. Thank you very much. And I appreciate you taking the questions.

Thanks Chris.

Thanks Chris.

The next question is from Yigal Nochomovitz with Citi. Please go ahead.

Hi. This is Carly on for Yigal. Thanks so much for taking our questions. Just a follow-up on some of your prior comments, can you talk in a little bit more detail about what you're doing to prepare for the XPHOZAH AdCom. I guess, are there any additional analyses you're putting together or can put together to help strengthen the argument around the clinical meaningfulness of the data?

Sure. Thanks, Carly. Much of this preparation is akin to organizing a Broadway show to ensure that every key point is communicated effectively within the limited time available. You will need to examine the science, clinical data, and patient needs, which will vary across different presentations, similar to what you have observed in other Advisory Committee meetings. There will be no new data submitted, as I mentioned earlier; we have provided all necessary data since filing the NDA. Our focus will be on what we believe represents clinical meaningfulness. It’s important to note that this program underwent thorough review, including every clinical protocol, statistical analysis plan, and endpoint, all meticulously assessed with the agency. Even in their Complete Response Letter, they acknowledged the importance of the decrease we achieved with XPHOZAH. We successfully met all primary and key secondary endpoints with highly statistically significant results. We will clearly highlight this as well as the patient need for a new solution, as taking multiple pills daily is often not feasible for them. Physicians should have the opportunity to base their decisions on the data we've generated regarding which patients are suitable candidates for XPHOZAH.

Okay. Great. That's really helpful. And then, we just had one question for Justin. Can you comment on how far the additional $40 million expected from KKC might extend the cash runway?

Sure, Carly. So, we are hopeful, as we mentioned for KKC to file in the second half of this year, and then seek approval from the agency in the second half of 2023 in Japan. We haven't disclosed the breakdown of the $40 million. It's going to be in two tranches between this fall and next fall, but $40 million would clearly impact our runway upon receipt, certainly, targeting second half of this year and next year. So, our burn will be going down as we grow our sales for IBSRELA. So, I can't give you specifics on how long the $40 million add, but it's clearly a material impact in extending our runway into 2023.

Okay. Got it. Thanks so much for taking our questions.

Thanks Carly.

The next question is from Joseph Thome with Cowen and Company. Please go ahead.

Hello. Good afternoon. Congrats on the progress and thank you for taking our questions. Maybe the first one just on the advisory committee, are you able to sort of suggest a label? So, maybe if they don't feel comfortable giving a broad label for serum phosphorus production in patients, can you say, only use it on top of binders or, patients that can't tolerate binders? Or are you able to kind of suggest anything that might make it a little bit easier and palatable for the FDA to approve there?

Yeah. Remember the audience for the AdCom are the members of the advisory panel, not the FDA as much, right? So the AdCom, we're going to be speaking to the established AdCom that's there as well as these additional participants that Dr. Stein referenced in his letter to us. And what we will say to them is, the treatment of hyperphosphatemia is something that's considered at a minimum monthly, as it relates to the serum phosphorus levels that are taken of every single dialysis patient at least once a month and often weekly or three times a week when they're in a dialysis session, and a dietician social worker, the staff there continue to remind them to watch their phosphorus, which is standard there. So the FDA will hear the panel. Importantly, we'll hear that understanding which patients are going to respond to which drug is something that's a very straightforward thing that they're accustomed to doing today. And that the data that we have generated represent powerful information for those physicians and caregivers that are part of the dialysis process to identify those patients that are going to respond and those who aren't or those who tolerate. And those that don't just as is the case today with binders. And right now, the only thing that they can do is switch to another binder or add a binder, which is nonsensical because they're not different from each other meaningfully in terms of the efficacy that they produce. So that's really the way that we'll approach it. I don't think we would go in and say, this is a proposed label. That's not really the purpose of the presentation to the AdCom.

Got it. And then, for IBSRELA, I mean, you mentioned some stocking, I guess, how should we think about revenues on a quarterly basis? Are they going to be reflective of kind of true patient demand, or is there going to be any pattern to stock the channel or anything like that? Any help…

We're five weeks into this, so all we have at this point is anecdotal evidence. It's an exciting time and a wonderful experience to be part of AdCom, especially after the decade of work we've put into bringing IBSRELA to market. However, we're not in a position to project or provide guidance on revenue expectations just yet. We ask for your patience as we gather more information, and we will share insights as we examine the reliability of prescriptions from IQVIA or Symphony. As Susan pointed out, there's a significant amount of specialty pharmacy involved that we need to understand better, along with how to report the data effectively. This is a time filled with positive anecdotal evidence, but it's too early to offer any specific guidance.

Okay. And maybe one more quick one, if I can just for Justin. R&D came down a lot, which is great to see from an expense standpoint. Is this now kind of the new steady state, or is there still room to come down in the rest of the quarters? Thanks.

Sure. That's fair. For Q1 and the rest of this year, I think that's a fair number. One thing we did call out in the press release is the stock compensation expense, the non-cash charge that is obviously highly variable, so that could have an impact, but again, that won't affect our runway. But the overall size of the research and development expenditure for the remainder of this year should be pretty consistent or slightly lower for the rest of this year.

Great. Thank you so much.

Thanks John.

The next question is from Laura Chico with Wedbush. Please go ahead.

Good afternoon. This is Sam on for Laura Chico. Thanks for taking our question. So, we have one on the tenapanor advisory committee meeting. Just wondering if you could frame for us the range of outcomes, that might come out of this meeting. Thank you very much.

So, it can be a unanimous vote. Yes. A unanimous vote, no. And everything in between. And all of us have observed the peculiarities of what have happened at AdCom over the last year plus. So, this is a fight that we're continuing to fight. We believe strongly in our data. We believe the voice of the KOLs have been part of this and those who have read about it since most all of our clinical programs have now been published. So, it's well known and well recognized out in the field as to what it is that XPHOZAH can provide their patients. So, getting to those physicians and patients who understand that and communicating that effectively to the AdCom. We believe will help us be on the right side of that boat versus on the negative side. And as we all know, the agency is not required to take the advice of their own committees. So that continues to be something that we will all watch mostly and feel that the strength of argument will be one that carries the day.

The next question is from Matt Kaplan with Ladenburg Thalmann. Please go ahead.

Hey, guys. Thanks for taking the questions and congrats on the AdCom. Just a follow-up to the last question in terms of, assuming you have a positive result from the AdCom, what's the timing after that for potential FDA action?

Sure. Yeah. So, since we don't have an active NDA in place, let me actually ask Rob Blanks, our Chief Regulatory Affairs and Quality Assurance Officer, to address the outcomes of what type of NDA we could potentially submit.

Thank you, Mike. This AdCom is a response to our appeal to OND. We know that 30 days after the AdCom takes place, we will receive a response from OND regarding the outcome of our appeal. If we are successful, we would likely obtain a complete response and undergo a two-month review of our NDA, which would primarily involve label negotiations at that stage. Alternatively, we could face a six-month review.

Got it. Okay. That's very helpful. Thank you. And then, shifting to the IBSRELA launch. Can you give us a sense in terms of the rollout of payer coverage and patient access corresponding to that in terms of commercial plans and Medicare, Medicaid plans, Part D? How we should think about that kind of in the coming year?

Sure. Susan?

Thank you, Matt, for your question. It's important to highlight that during this early launch phase, physicians can access IBSRELA by going through an exception process. In these initial stages, due to the unique mechanism of the drug and our focus on using it for patients in need of an alternative treatment approach, we are seeing physicians motivated to navigate this exception process successfully. Additionally, many high-writing gastroenterology groups are connected to specialty pharmacies that assist them in overcoming these hurdles. Gastroenterologists often prescribe various specialty products, including costly therapies for ulcerative colitis, Crohn's disease, and HCV, which means they already have systems in place. This early phase of our launch is centered on creating demand and harnessing the motivation of gastroenterology groups to manage exceptions and secure prescriptions. As we proceed, we are also engaging with payers to help alleviate some of these challenges, making it easier for physicians to obtain IBSRELA for patients who truly need it. Overall, we expect that access on the commercial side will be established first as we begin to secure our position. We plan to continue focusing on this throughout the launch period in 2022, while Medicare and Medicaid will typically present more challenges in terms of timelines as we work to address these barriers.

Okay. Okay. Thank you. And then, in terms of pricing and gross to net, any comments on that?

Yeah. Susan?

Overall, we have announced the price for IBSRELA at $1,500 a month. This pricing is based on the clinical value proposition. IBSRELA addresses a gap in the market for patients who are not adequately managed, with no other options available. The pricing for IBS treatments generally ranges from about $500 to a high of $1,800 or $2,000 for IBS diarrhea products, so our price point fits within that landscape. It is linked to the value proposition and our targeted approach, with the goal of achieving a high single-digit market share. Regarding costs, we will not be offering rebates to match the positions of Linzess and Trulance, as that market is already established. Different plans may prefer Linzess or Trulance, but we are focusing on patients who need an alternative approach, and physicians are willing to make exceptions for these cases. Therefore, from a gross to net perspective, we are not planning to heavily rebate the product, but we will collaborate with payers to reduce barriers. Additionally, we need to consider our distribution network and the affordability aspect of access. For commercial patients, we will implement a copay program to help offset their out-of-pocket expenses for IBSRELA. These are the main points to consider.

Great. Thank you, Susan, for the added detail. Thanks. Thanks for the questions.

Thanks Matt.

This concludes our question-and-answer session. I would now like to turn the conference back over to Mike Raab for any closing remarks.

Thanks for the transformational progress as we launch IBSRELA for patients with IBS-C and continue to navigate the regulatory process with XPHOZAH. We look forward to keeping you apprised of our progress in the coming months. Debbie, you may now end the call.

Okay. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.