Ardelyx - Q3 2024

Transcript

Operator (participant)

Good afternoon, ladies and gentlemen, and welcome to the Ardelyx Q3 2024 earnings call. Our host for today's call is Caitlin Lowie, Vice President of Corporate Communications and Investor Relations at Ardelyx. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. I would now like to turn the call over to your host, Caitlin. You may begin.

Caitlin Lowie (VP of Corporate Communications and Investor Relations)

Thank you. Good afternoon, and welcome to our Q3 2024 financial results call. During this call, we will refer to the press release issued earlier today, which is available on the Investor section of the company's website at ardelyx.com. During this call, we will be making forward-looking statements that are subject to risks and uncertainties. Our actual results may differ materially from those described. We encourage you to review the risk factors in our most recent quarterly report on Form 10-Q that was filed

today and can be found on our website at 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. Our President and CEO, Mike Raab, Chief Commercial Officer, Eric Foster, and Chief Financial and Operations Officer, Justin Renz, will share prepared remarks before we open the call to questions. I will now hand the call over to Mike.

Mike Raab (President and CEO)

Good afternoon, everyone, and thank you for spending part of your Halloween with us this year. It was a busy Q3, and Eric, Justin, and I will bring you up to speed on the latest developments and provide some insight into what you can expect in the months ahead. IBSRELA is making a difference. We continue to hear from treating healthcare providers and patients that IBSRELA is delivering meaningful and important

benefits to IBS-C patients who, despite treatment with established therapies, have continued to suffer from the symptoms of this debilitating condition. As you can see from the performance this quarter, demand for this effective first-in-class therapy continues to grow. We are excited about the future of Ibsrela. And with the latest expansion of our field force complete, our confidence that IBSRELA is a billion-dollar drug before patent expiry is as strong as ever.

Xphozah launch continues at a phenomenal pace, demonstrating the clear unmet medical need among dialysis patients. We have said it before, and it continues to be true. There is a dire need for innovative therapies like Xphozah for dialysis patients. For almost 50 years, binders have been the only prescription therapy available to lower phosphorus levels. In under a year since launch, Xphozah is demonstrating the critical role it has in helping patients manage their hyperphosphatemia. Physicians are prescribing

Xphozah because it works, and it is helping patients achieve serum phosphorus levels that have previously been unattainable. The positive results they see in their patients drive this adoption. We, along with you, recognize that there is uncertainty around coverage for Xphozah for Medicare patients. This is why we've deployed multiple strategies with a goal to provide uninterrupted access to Xphozah for all patients.

Please allow me a moment to discuss how we got here. With the establishment of the End-Stage Renal Disease Prospective Payment System, or bundle, CMS proposed to include in the bundle all drugs and biologics furnished during dialysis services. Their expectation was that the bundle payment would increase patient access to innovation and care while more efficiently managing the costs associated with dialysis. The sad reality is that is not how it has turned out. Rather, as you've heard me say many times during our calls, is that the unintended consequence of this policy is that patients end up with limited access to innovation, the complete opposite of what was the original intent.

Due to this erroneous way of thinking, access to much-needed innovative drugs is significantly restricted, if not prohibited, causing some of those innovative therapies to effectively be removed from the market and a dearth of new innovative medications being developed for dialysis patients. This policy has resulted in negative patient experiences and poorer health outcomes. Historically, since the establishment of the bundle, oral-only therapies have not been included in the bundle payment for

Medicare patients, but rather have been paid under Medicare Part D. However, CMS continues on the path to eliminating coverage for oral-only therapies under Part D on January 1st. Recall that we have been fighting for oral-only phosphate lowering therapies to retain Part D coverage for Medicare patients since the potential benefit Xphozah could have for patients became apparent more than half a decade ago.

Xphozah is clinically proven to be a safe and effective medicine that offers something fundamentally different for the hundreds of thousands of dialysis patients who cannot tolerate phosphate binders or for whom a binder alone does not work well enough to achieve and maintain target phosphorus levels. We continue to fight on every front possible. We are partnered with a broad coalition of patients,

physicians, trade, community organizations, and minority groups who are disproportionately impacted by kidney disease and dialysis, all of whom support the Kidney Patient Act, bipartisan and bicameral legislation that we hope will be passed before the end of the year. There is tremendous support behind this bill, with 38 co-sponsors in the House and two sponsors on the companion Senate bill.

Separately, we, in partnership with the American Association of Kidney Patients and the National Minority Quality Forum, have filed a lawsuit claiming that CMS's actions to include oral-only therapies in the bundle are outside of its statutory and regulatory authority. We are in the early stages of that lawsuit and hope that before the end of the year, the Court will grant a preliminary injunction to enjoin CMS from proceeding with this plan. There's a third and essential element to our strategy, and that is the actions

that we have taken to help protect access for patients and our business, even if the legal or legislative options are unsuccessful. Importantly, we elected, after significant research and discussion and careful consideration, that the best way for Ardelyx to preserve the opportunity for broad access to Xphozah for all patients was to not apply for TDAPA.

We determined that by not applying for TDAPA, we would help preserve the shared decision-making process between patients and providers to ascertain the best course of therapy to manage hyperphosphatemia and to help ensure patients are not subject to a protocol that limits that critical relationship. Momentarily, Eric will share with you how the Xphozah team has begun to educate and

communicate this approach. A short two months from now, by the end of 2024, we will know much more than we do today. Know that there are important truths that have brought Ardelyx to where we are today and will continue to drive us in the future. First, there are many patients who continue to struggle to manage their phosphorus. Second, Xphozah is an important medicine that we know is helping patients achieve target phosphorus levels.

And third, Ardelyx is committed to ensuring that patients who are prescribed our medicines have access to treatment. We believe that the decision to pursue and support legal, legislative, and commercial strategies has positioned us to help ensure that Xphozah is available for all patients, regardless of the

scenario we find ourselves in on January 1st. We believe there is an important and substantive business for Xphozah in all scenarios. As we learn more over the ensuing months, we will be able to provide you with greater clarity. Critical to our success will be the work that Eric and his team are doing. I'm really excited to welcome Eric not only to this call, but to Ardelyx.

In a short time, Eric has brought a fresh perspective to our team and deep knowledge and insight to help lead us through the uncertainty we face with Medicare reimbursement for Xphozah and the opportunities to accelerate the growth of IBSRELA and Xphozah while positioning our commercial organization to take advantage of other products we may develop, in-license, or acquire as we continue to build an important patient-centric enterprise. Eric will review the Q3 performance and provide more detail on how we are advancing our commercial strategies for the future. Eric?

Eric Foster (Chief Commercial Officer)

Thanks, Mike, for that kind introduction. I am thrilled to join you all today and to be a part of Ardelyx and the remarkable growth story that I see ahead. Before I speak to the successes from the quarter, I'd like to share a patient story, like so many that we hear every day, that reinforces why we do what we do. Recently, a patient's caregiver contacted us because her mother, a longtime IBS-C sufferer, had been

given a sample of Ibsrela. This patient had suffered with the symptoms of IBS-C for a long time and had tried many treatment options. She spoke about how her mother wanted to live a full life, but her GI issues continued to take over. They were excited about Ibsrela because they heard it was a different option, and they were eager to get started on treatment.

It's stories like this one that attracted me to Ardelyx. Ibsrela is a unique and different option for patients suffering from IBS-C, and we are deeply committed to supporting patients to access therapy. For nearly 25 years, I have dedicated my career to bringing meaningful medicines to patients, and I have seen firsthand how innovative therapies can dramatically improve patients' lives, and it is evident that Ibsrela and Xphozah, medicines discovered and developed by Ardelyx, offer much-needed and truly

differentiated options for patients. After spending time recently in the field and engaging directly with providers, as well as working closely with the commercial leadership team, it is clear that we have a solid foundation in place. First, there are so many patients with IBS-C and hyperphosphatemia whose conditions are not well managed and now have different options with Ibsrela and Xphozah. Second, patients have a defined path to access.

They are receiving treatment, and they are having positive benefits, resulting in more physicians adopting Ibsrela and Xphozah, and third, we have a high-performing and committed team that is focused on removing barriers and bringing these medicines to patients as quickly as possible. As a result of our commercial approach, we delivered consistent growth for both medicines during the Q3.

Let me first start with Ibsrela. Growth continued at a very strong pace, recording a 15% increase in net sales over the Q2. We continued to see significant demand for Ibsrela, reflected in continued growth across all of our key demand metrics, including new and refill prescriptions and new and repeat writers. We also began to see encouraging indicators of the impact of the sales team that we hired early in the expansion process.

Recently, I returned from the American College of Gastroenterology annual scientific meeting, and the response from the GI community to Ibsrela was incredible. Ibsrela is well established as a meaningful treatment for healthcare providers who now have a different option to treat this complex condition. We also used the conference as an opportunity to highlight key data we recently collected as part of the IBS

in America 2024 supplemental survey related to the impact that IBS-C has on the lives of patients. 90% of those patients surveyed indicated that their condition had a negative impact on their life, with a majority indicating they feel a negative impact on their mental and emotional health, intimacy, relationships, and sense of independence. More than one-third surveyed patients described their quality of life as poor or fair.

These results further reinforce our recognition that there are a significant number of patients who continue to experience the symptoms of their condition and could benefit from Ibsrela. Our team is focused on driving demand for Ibsrela, supported by the expansion of our field sales team, which I'm happy to tell you was completed towards the end of the Q3. Moving forward, our team is trained, ready,

and they are in the field. We expect to see increased effort and impact from this expansion. The team is focused on driving broad adoption and accelerating growth by helping our target HCPs expand their view to the appropriate Ibsrela patient. We remain uniquely positioned as the only non-serotonergic option in a different class, with clinically proven efficacy and safety for IBS-C patients. We continue to be encouraged by the success of Ibsrela and are confident in our path to $1 billion.

I look forward to sharing more details on our expectations and plans for Ibsrela in the future. Now, moving to Xphozah. Xphozah continues to deliver an exceptional launch, recording a 39% increase in net sales revenue growth quarter over quarter, anchored by key foundational elements. There's a large population of patients whose hyperphosphatemia is not well managed despite treatment with a

phosphate binder. Xphozah provides a non-binder option that is clinically proven to be safe and effective. This is an established market with a targeted call point for our sales team, and nephrologists are receptive to Xphozah's clinical profile and messaging, and finally, there is a defined path to access. The strong performance and response from the nephrology community reflects the need among patients for Xphozah to help lower and manage phosphate levels to target.

Since launch, patients are getting on treatment and seeing phosphorus levels come down and remain at target levels. We consistently hear stories of patients who are now seeing the benefits of Xphozah after struggling for years to control their phosphorus on binders alone. Their sentiment was clear at last week's annual Kidney Week held by the American Society of Nephrology. As Mike discussed earlier,

irrespective of the uncertainty related to Part D coverage for Medicare patients, we are not changing what we are doing today. Our field-based team continues to encourage nephrologists to prescribe just as they do today, based on a patient's clinical need. We are helping the nephrology community and care teams to understand that even in the event that Medicare Part D coverage is eliminated, their ability to prescribe Xphozah remains unchanged.

The Xphozah team remains steadfast on driving demand today and demonstrating the benefit that Xphozah brings to patients. Today, just three months in, I'm even more excited about Ardelyx's future and our ability to help the patients that we serve. We are just scratching the surface, and the potential for Ibsrela and Xphozah is significant, and it is up to us to capture that opportunity and to capture it as quickly as possible. I will now hand it over to Justin, who will walk you through the financials from the Q3. Justin?

Justin Renz (Chief Financial and Operations Officer)

Thank you, Eric, and it's great to have you on these calls and at Ardelyx. We recorded an exceptionally strong performance during the Q3, focusing on driving our top-line growth, managing our expenses, and adding to our cash position. We entered the Q4 with positive momentum and expectations of continued growth and a strong balance sheet to support future opportunities. Now, let's walk through

the financials, starting with revenue. We reported $98.2 million in total revenue during the Q3, compared to $56.4 million in total revenue during the same period in 2023, driven by significant growth in net product sales for both products. For the Q3 of 2024, net product sales revenue for Ibsrela was $40.6 million, nearly double our revenue from the same period of 2023, and 15% quarter-over-quarter growth compared to the Q2 of this year, driven by strong demand.

Our Q3 gross-to-net deduction for Ibsrela was 30.0%, consistent with our prior quarter. As a result of the strong performance in the Q3, as well as the expected impact of the expanded sales force, we are narrowing our guidance and expect full year 2024 Ibsrela U.S. net product sales revenue to be between $145 and $150 million. Now, turning to Xphozah. Xphozah continued its exceptional launch, reporting

$51.5 million in Q3 net product sales revenue, up from $37.1 million we reported in the Q2 of 2024. This was driven by strong demand from healthcare providers who clearly need a new and different option for dialysis patients to help them achieve target phosphorus levels. In addition to strong demand for Xphozah, our gross-to-net deduction improved from 21.4% in the Q2 to 19.3% for the Q3.

We are pleased with our top-line results and expect continued growth in the Q4. Our commercial approach is working, and our teams are executing at the highest level to build and maintain the momentum we have established for both Ibsrela and Xphozah. In addition to product revenue, we also had $5.3 million in partner product supply revenue, as well as just over $800,000 in non-cash royalty

revenue during the Q3 of 2024, and now for the expense and cash side. Research and development expenses were $15.3 million in the Q3 of 2024, compared to $8.6 million during the same period of last year, reflecting increased medical engagement with scientific communities and pediatric clinical trial activities. Selling, general and administrative expenses were $65.0 million for the Q3, compared to $32.7 million for the same period of 2023.

The increase was related to commercial activities for Ibsrela and Xphozah, as well as the expansion of the Ibsrela sales team. Substantial top-line growth, combined with thoughtful expense management, resulted in a net loss of approximately $800,000, or less than a penny per share. In addition, our Q3 of 2024 results included $11.1 million in combined non-cash expenses from share-based compensation

and non-cash interest expense related to the sale of future royalties. We finished the Q3 in a strong cash position. As of September 30, 2024, we had total cash, cash equivalents, and short-term investments of $190.4 million, as compared to $184.3 million at the end of 2023 and $186 million at the end of the Q2. As we continue to thoughtfully strengthen our balance sheet, we announced today that we drew $50 million and amended our debt agreement with SLR Capital.

This amendment allows us to draw an additional $50 million, sets the interest rate for the tranche we drew today and the additional $50 million of committed capital at SOFR plus 4.02%, and following extended the interest-only period to July 1, 2028, for all borrowings. The strong cash position we finished the Q3 with, combined with the additional $50 million, gives us a pro forma cash balance of

over $240 million, providing optionality as we pursue our goal of building a patient-centric enterprise that Mike mentioned earlier. To recap, we have once again delivered a remarkable performance. We drove substantial top-line growth across our product lines, and we expect continued growth in the Q4. We managed our operating expenses, maintained a strong balance sheet, and, as always, focused on maximizing shareholder value. With that, I'll hand it back to Mike.

Mike Raab (President and CEO)

Thank you, Justin and Eric. The Q3 was another exceptional one. We focused on executing our key priorities, including maintaining our commercial momentum, supporting efforts to preserve patient access to Xphozah, strengthen our cash position, and envision the next phase of growth for the company. The result is another quarter of excellent progress, consistent growth, and, most importantly,

doing what is right for the patients we serve. Because we believe that if we serve patients, we will serve shareholders. Before I open the call to questions, I want to thank our shareholders who have followed and supported us on this journey. We will learn much in the weeks and months ahead together. You have

our commitment that we will continue to make decisions that are in the best interest of patients, employees, and you, our shareholders. And, as always, I want to express a special thanks to Team Ardelyx and the patients and physicians we serve. You are the driving force behind what we do. I will now open the call to questions. Operator?

Operator (participant)

If you would like to ask a question, please press star one on your telephone keypad now. You'll be placed into the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you have a question, please press star one on your phone now. And our first question comes from Louise Chen from Cantor Fitzgerald.

Louise Chen (Managing Director)

Hi, congratulations on the quarter end. Thanks for taking my questions here. So I had a few for you. Wanted to ask you, what % of Xphozah sales are not part of the Medicare bundle? And then how do you think about expanding your product portfolio? You talked about that a few times today. And last question I had for you was the peak sales for IBSRELA being $1 billion plus. How long do you think it will take to achieve that? Thank you.

Mike Raab (President and CEO)

Hi, Louise. Great questions. So first, in terms of percentages, I think what we've shared in the past is the general numbers of 60% Medicare, 40% non-Medicare. And that moves around a little bit, but that's a good general way to think about it. In terms of your second question of how we expand beyond now,

that's the reason that we brought on Mike Kelleher, and those efforts are beginning now and ongoing. We now have the luxury of the strong balance sheet that we've been able to build and continue to look into doing that going forward. So more news I expect coming from those efforts in the future. And I'm sorry, the third question?

Louise Chen (Managing Director)

The third question was just on your peak sales for IBSRELA or IBSRELA?

Mike Raab (President and CEO)

Yeah. Yeah, I mean, I think at this stage it's probably a little bit too early to give a specific number on that. We just finished the expansion. And as Eric mentioned in his comments, they're trained in the field. ACG was a phenomenal turnout for that team. And let's hold off on that until we see the performance with the addition.

Louise Chen (Managing Director)

Thank you.

Mike Raab (President and CEO)

Thanks, Louise.

Operator (participant)

Our next question comes from Dennis Ding of Jefferies.

Dennis Ding (Vice President and Equity Research Analyst)

Hi, good afternoon. Thanks for taking our questions. A few from me. So for Xphozah in 2025, given it's been a few months since we announced you guys won't apply for TDAPA, what are the different options on the table in terms of commercial strategy? And if you could be a little bit more granular. And then, excuse me, on Ibsrela, just talk about the pushes and pulls on the guidance. It seems a little bit conservative. Was there anything one-timer or anything that you're seeing on the ground? Thanks.

Mike Raab (President and CEO)

Yeah, so let me address the second one first. As you've heard me say probably too many times, I don't want to get over my skis. And we just finished the expansion with the additional adds to the Ibsrela team. So I'm very encouraged by what we see. And I think narrowing the guidance gives you some sense in terms of our confidence. So there's not a there there that's negative. I see only positives in terms of the

expansion of what we saw in ACG. In terms of what it looks like going forward, I think really pay attention to what Eric said. The objective here is for physicians not to change what they're doing today. This is a coverage issue as the way to simply think about it. Our objective is clearly, with everything that we do and have done, is to ensure the opportunity for access for all patients, which we believe we're doing with the three approaches I described.

Dennis Ding (Vice President and Equity Research Analyst)

Thank you.

Operator (participant)

Our next question comes from Roanna Ruiz of Leerink Partners.

Roanna Ruiz (Senior Research Analyst)

Good afternoon, everyone. So a couple from me. I was curious if you could elaborate a bit more on your plans around possible education and outreach to prescribers of Xphozah ahead of January 1st. I know there's a lot of moving pieces, but I was also curious if what are you thinking about in terms of engaging with different payers, particularly the non-Medicare side as well?

Mike Raab (President and CEO)

Yeah, so I'll ask Eric to comment a little bit on that. But it's really kind of a simple message. Don't change what you're doing, right? And going into next year, if we aren't successful with that third leg of the stool and the strategy, is that they continue doing what they're doing. And I think as the message is beginning to resonate, I'll ask Eric to comment on his experiences at ASN, which just happened as well, as this message began to percolate.

Eric Foster (Chief Commercial Officer)

Yeah, thanks, Mike. So what we know, physicians are very interested in Xphozah and this treatment to address the unmet need that's out there. Just like we're thinking for 2025, physicians don't differentiate between the Medicare population and the non-Medicare population. So we're going to continue to message the clinical benefits today, as well as access to therapy, and continue that in 2025, keeping the

nephrologist at the center of the decision-making. I can tell you, just coming off of ASN, there continues to be a tremendous amount of excitement on Xphozah and the opportunity ahead. Like I said, the physicians aren't really differentiating between Medicare and non-Medicare. So we need to continue to be steadfast in our execution and delivering those clinical messages so that physicians can make the best choice for their patient based on clinical needs.

Mike Raab (President and CEO)

And to your latter part of your question is, there's nothing unique in any communication that we have with payers, right? It is status quo in the way that we're operating through ArdelyxAssist to have those patients go through the prior authorization process. So we don't end that. I mean, it sounds funny, but it's keep doing what you've been doing, which the decisions we've made allows that to occur.

Roanna Ruiz (Senior Research Analyst)

Got it. Thanks.

Mike Raab (President and CEO)

Thanks.

Operator (participant)

Our next question comes from Yigal from Citigroup.

Reina Harris (VP)

Hi, this is Reina on for Yigal. Thanks for taking my question. I was just wondering if you've made any progress with regard to the injunction to temporarily halt implementation of including orals in the dialysis bundle in 2025. Any additional color there would be much appreciated.

Mike Raab (President and CEO)

Yeah, I think as you heard in my opening comments, we hope that there would be some action on that before the end of the year. Otherwise, there's not really any additional insight that we can provide.

Reina Harris (VP)

Great. Thanks for taking my question.

Mike Raab (President and CEO)

Thanks.

Operator (participant)

Our next question comes from Laura Chico from Wedbush Securities.

Laura Chico (Managing Director and Equity Research)

Hi, good afternoon. Thanks for taking the question. Just one, Justin, I think I missed what you said on the gross to net improvement in the quarter for Xphozah. And then with respect to Ibsrela, what would be appropriate timing for 2025 guidance? Thanks very much.

Mike Raab (President and CEO)

Yeah, so Laura, the latter part first, as we look at the performance of the addition of the sales force, the new ADDs, let's let that settle in a bit before we give guidance. But it'll be in the early part of the next year. We won't leave you hanging too long. Justin.

Justin Renz (Chief Financial and Operations Officer)

Thank you, Laura. In the third quarter, our gross-to-net deduction improved from 21.4% to 19.3% in the third quarter. So this improvement was primarily dependent on our patient payer mix, the utilization of our commercial copay, and mild changes there. As you might imagine, we're pleased with the results to date. And as we learn more about the patient mix and the copay claims and the amounts of the claims, we'll give you more guidance going forward like we do for Ibsrela, where we mentioned 30% plus or minus 5% is the general rule.

Laura Chico (Managing Director and Equity Research)

Thanks very much, guys.

Mike Raab (President and CEO)

Thanks, Laura.

Operator (participant)

Our next question comes from Joseph Thome from TD Cowen.

Joseph Thome (Managing Director and Senior Research Analyst)

Hi there. Good afternoon. Congrats on the progress, and thank you for taking my questions. Maybe just going into the fourth quarter, do you expect any differing dynamics in terms of stocking of Xphozah or any pull forward of prescriptions or anything that might be possible, I guess, for either the patients or the physicians to almost prepare for a potential bundle scenario? Or do you think there'll be anything to

point out there? And then second, just on the Xphozah court case, obviously, the legislation side is a little bit more maybe straightforward if that's able to go through. But if the injunction is granted by the end of the year, what's the next step then? Kind of how much visibility would you have after that standpoint on next steps? Thank you.

Mike Raab (President and CEO)

Hey, Joe, thanks. I think if that were to occur, we'll provide more perspective what that then means if we get that. It's premature at this point to give any more information than that. As it relates to pulling things forward, what I would say is what the team has put in place is a continuity of care program, which I think is very important to not have stuff like that occur, where if you are prescribing for a Medicare patient, you can come into a continuity of care program until things resolve. So I wouldn't anticipate that. I don't know, Eric, any comments that you would like to share on that?

Eric Foster (Chief Commercial Officer)

No, I agree. I think we've got a great program with continuity of care, and we've got really good relationships with wholesalers and distributors, and there really hasn't been any conversations about that.

Joseph Thome (Managing Director and Senior Research Analyst)

Great. Thank you. And then maybe just one more question from me. I guess, does it seem like the dialysis centers are even preparing, I guess, for this change January 1st? It seems like this would be a big change for just like a light switch on and off, I guess. Are you seeing anything at the dialysis centers themselves that would indicate that they're preparing or not preparing one way or the other?

Mike Raab (President and CEO)

No, I think, Joe, one of the biggest challenges for all dialysis providers, and certainly the independents, the rural, and the small and nonprofits, is the infrastructure that must be put in place to manage pills, and everything that's going to come from this is going to be debilitating for many, and that is one of the fundamental risks, honestly, of what this policy is ultimately going to do: further make dialysis a difficult

thing for patients to get access to. We certainly know of rural communities where people three times a week are having to drive hours to be dialyzed. They need that to live, so yes, there are efforts they have to underway, which is the basis of an awful lot of those providers supporting the Kidney Patient Act. It's a catastrophe. It's bad policy, and it's bad for patients, which is why we're working so diligently both on the Patient Act and the legal front.

Joseph Thome (Managing Director and Senior Research Analyst)

Perfect. Thank you. Very helpful. Sending good luck.

Mike Raab (President and CEO)

Thanks, Joe.

Operator (participant)

Our next question comes from Ryan Deschner of Raymond James.

Ryan Deschner (Vice President and Senior Equity Research Analyst)

Hi there. Congrats on another strong quarter for both Ibsrela and Xphozah. My question is, how much of the uptick we are seeing in Ibsrela scripts over the past few months are you directly attributing to getting the expanded sales team online versus other factors? Is every member of this team now up, fully trained and deployed? And then also follow-up question.

Mike Raab (President and CEO)

Sure. Let me just briefly address the first question, and I'll ask Eric to comment on it too. In Eric's comments, you heard him say that we're beginning to see some impact from those who came on early in the expansion, but likely not the majority that came on and are now in the field and trained. So, Eric, any color you want to add to that?

Eric Foster (Chief Commercial Officer)

No, I think that's right. We started the expansion a little bit earlier in the year, and we certainly have seen impact from those individuals that have come on, and that's what gives me confidence as we move forward now, having a full team in place, completely trained and in the field, so plenty of opportunity that's out there. I'm looking forward to having a full team in place for fourth quarter.

Ryan Deschner (Vice President and Senior Equity Research Analyst)

Fantastic. And just a quick follow-up. Do you have any updates on partnerships in Europe or rest of the world for Xphozah or a timeline, more resolution on the approval in the Chinese market? Thank you.

Mike Raab (President and CEO)

Yeah, so for the Chinese approval, we still anticipate that would be before the end of the year and no updates or news on other partnering.

Ryan Deschner (Vice President and Senior Equity Research Analyst)

Got it. Thank you.

Mike Raab (President and CEO)

Thanks, Joe.

Operator (participant)

Our next question comes from Ed Arce of H.C. Wainwright.

Thomas Hoffmann (Managing Director)

Hi, everyone. Good afternoon. This is Thomas asking a couple of questions for Ed. Thank you so much for the general questions. Perhaps first question is for Justin. Can you discuss the latest gross-to-net for Ibsrela and then also how much improvement can we expect from current level and what would it take?

Caitlin Lowie (VP of Corporate Communications and Investor Relations)

So for Ibsrela, as we've said before, our gross-to-net deduction is around 30% plus or minus 5%. And so our third quarter was in line with that precisely. And then again, going forward, we'll give updates, obviously, in the early part of the year. As a general premise, in the first quarter of 2025, our gross-to-net is higher when plans reset, insurance policies reset, some folks get new coverages, and there may be new Medicare rebates taking effect in January of 2025 as well.

Thomas Hoffmann (Managing Director)

Got it. And then I guess for Xphozah, you mentioned earlier Ibsrela sales guidance, kind of expected in early next year. Can we also expect Xphozah sales guide for next year around the same timeframe?

Mike Raab (President and CEO)

With all the moving parts with Xphozah, I think it's a bit premature for me to say when we would give guidance. It would be nice to have steady state predictable things. If we're able to, we'll do it as soon as we can. I think expecting it at the beginning of next year may be a little bit premature.

Thomas Hoffmann (Managing Director)

Got it. And then one final question, perhaps this one for Eric. You mentioned earlier in the call, you're really seeing early impacts, especially from the sales rep that are early on in the expansion process. What metrics can we focus on in the near and long term? And what would you consider to be a successful expansion?

Eric Foster (Chief Commercial Officer)

Yeah, so for me, what I look at is with the increased individuals in the field, are they continuing to have an increase in their call activity? We certainly are seeing that simply with just having more representatives out there in the field. And I'm very proud of the team this year to be able to show an increase in new and total prescribers, as well as new and total refill prescriptions. So for me, those are the indicators that we're focused on. And we've shown good growth this quarter versus last quarter. So continuing to have that solid quarter-over-quarter growth.

Thomas Hoffmann (Managing Director)

Got it. Thank you again for picking up our questions. And looking forward to the progress for Xphozah and Ibsrela.

Mike Raab (President and CEO)

Thank you very much.

Operator (participant)

Our next question comes from Matt Kaplan of Ladenburg Thalmann.

Matthew Kaplan (Managing Director)

Hey, guys. Thanks for taking the questions and congrats on the really strong quarter. Just to dig in a little bit more to what you're seeing or what you're hearing in terms of the progress and moving forward with the Kidney Patient Act? Any detail you can share on what you're hearing on the legislative front?

Mike Raab (President and CEO)

Yeah, I mean, if you do what I do and watch congress.gov, you can see all the co-sponsors that are signing up in the House, right? As I said in my opening statement, we now have 38, two in the companion bill in the Senate. So it is progress and exciting progress at that, plus all the coalition has been built around the Patient Act. So we're punching above our weight class. I don't know what other kind of analogies that you can use or metaphors, but we have a lot of attention. Now our system needs to work to get the bill approved and passed.

Matthew Kaplan (Managing Director)

That's good. And then with respect to the TDAPA lawsuit and CMS, are there any specific timelines that the court has to get back to you with respect to issuing a potential preliminary injunction?

Mike Raab (President and CEO)

Yeah, I mean, so that needs to occur before the end of the year. So that's why we're hopeful that we will all know something more before that.

Matthew Kaplan (Managing Director)

Okay, so the court must decide by the end of the year.

Mike Raab (President and CEO)

Yeah.

Matthew Kaplan (Managing Director)

Okay. All right. And then I guess lastly on Xphozah, I guess you guys recently, I guess, got back from the ASN meeting. Any feedback that you're hearing from doctors out there with respect to how they're utilizing Xphozah right now to treat their patients?

Eric Foster (Chief Commercial Officer)

Yeah, thanks for that. Listen, I was incredibly impressed with the team this year at ASN. And in talking with physicians, they're using it on label in addition to the binders. And they're really seeing significant results with these patients out there that aren't well managed on their phosphate binders. So it continues to give me confidence in the direction that we're headed and, most importantly, the opportunity in front of us.

Matthew Kaplan (Managing Director)

Thanks, Eric. Thanks, guys.

Eric Foster (Chief Commercial Officer)

Thanks, Matt.

Operator (participant)

Next question comes from Chris Raymond of Piper Sandler.

Christopher Raymond (Senior Research Analyst)

Hey, thanks, guys. I know this question's been asked a couple of ways already, and I know you're not guiding on Xphozah. And Mike, I heard what you said about your messaging to nephrologists to just keep doing what you're doing. But I have to ask, if 60% of your patient base is likely to not be covered come January 1st, again, without any legislative or legal progress on your part, how do docs not start to

pull back use? And in particular, I think there could be an argument for this. We did a KOL call earlier this month where the KOL was kind of resisting the notion that there'd be a bifurcated treatment, that he'd find a way to keep patients on therapy. And I'm kind of flummoxed as to how that could be. Any sort of thinking there that you can help maybe align this on?

Mike Raab (President and CEO)

Very simply, this is about access, not reimbursement. So what does that mean? If you, as a nephrologist, continue doing what you're doing and you send prescriptions into our ArdelyxAssist, it will be adjudicated whether or not it is a prescription that has reimbursement. And if it doesn't, as it is today, your patient will be able to potentially meet the benefit requirements of our patient assistance program.

So the objective, as I said in my opening statement, was that our objective is to make sure our patients have access to the drugs that we've created. And that's why the message to nephrologists is, keep doing what you're doing. We don't anticipate or expect them to determine and bifurcate. That's absolutely what we're trying to avoid. That's not their job. Let us do it on the back end with our Ardelyx Assist and identify those that still have reimbursement. For those that qualify, they could have access to the patient assistance program.

Christopher Raymond (Senior Research Analyst)

Okay. So then the way it would show up then, I guess, on the P&L would be, again, barring any sort of progress on all the efforts that you guys have, would just be this large free drug expense. Is that a fair statement?

Mike Raab (President and CEO)

There would be a free drug expense in marketing as there is now.

Christopher Raymond (Senior Research Analyst)

Yeah. Okay. Thank you.

Mike Raab (President and CEO)

Thanks, Chris.

Operator (participant)

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

Mike Raab (President and CEO)

Thank you, everyone, for joining us this evening. As always, we remain focused on our priorities and will provide information updates when we can. In the meantime, we remain steadfast in our commitment to patients and to maintaining our commercial momentum. With that, we can close the call. Thank you, operators.