Ardelyx Q2 2025 Earnings Call Transcript

Quartr
Provided by Quartr
August 4, 2025

Key Takeaways

  • Positive Sentiment: Reported second quarter revenue of $97.7 million, up 33% year-over-year, and raised full-year 2025 IBSRELA net sales guidance to $250 million–$260 million.
  • Positive Sentiment: Exposa net sales reached $25 million in Q2, marking a 7% sequential increase (27% adjusted) despite reimbursement changes.
  • Neutral Sentiment: Improved Q2 net loss to $19.1 million from $41 million a year ago and fortified the balance sheet with a $50 million debt draw.
  • Neutral Sentiment: Announced executive updates including the elevation of Mike Kelleher to Chief Business Officer, hiring of new C-suite leaders, and upcoming CFO transition.
  • Positive Sentiment: Reaffirmed peak sales opportunities of over $1 billion for IBSRELA and $750 million for Exposa based on current momentum.
AI Generated. May Contain Errors.
Earnings Conference Call
Ardelyx Q2 2025
00:00 / 00:00

There are 15 speakers on the call.

Operator

Good day, everyone, and welcome to the Ardellix First Quarter twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. Now I'd like to turn the conference over to Caitlin Lauwey, Vice President of Corporate Communications and Investor Relations. Caitlin, you may begin.

Speaker 1

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

Speaker 1

We encourage you to review the risk factors in our most recent quarterly report on Form 10 Q that will be filed today and can be found on our website at ardells.com. While we may elect to update these forward looking statements in the future, we specifically disclaim any obligation to do so even if our views change. Our President and CEO, Mike Robb, will begin today's call with opening remarks and an overview of the company's progress during the 2025. Next, Chief Commercial Officer, Eric Foster, will provide an update on the performance of Israel and Exposa. Justin Renz, Chief Financial and Operations Officer, will conclude today's prepared remarks with a review of the company's financial performance during the second quarter ended 06/30/2025, before we open the call to questions.

Speaker 1

With that, let me pass the call over to Mike.

Speaker 2

Good afternoon. It's a pleasure to be with you today to share our second quarter twenty twenty five results, a quarter that reflects the strength of our strategy, the momentum behind our products and exceptional execution by our team. We're proud to report a standout quarter for both the XERLA and EXFOSA reinforcing the power of our commercial model and the real world impact our differentiated therapies are having for patients with IBS C and CKD on dialysis. These results validate our strategy and highlight our ability to deliver on our priorities. In the second quarter, we generated $97,700,000 in total revenue representing 33% year over year growth, a strong signal of accelerating demand across our portfolio.

Speaker 2

Israel continues to perform with net sales revenue of $65,000,000 during the second quarter, up 84% year over year and 46% quarter over quarter. Israel demand growth is broad based with record highs across all our key indicators. Our Israel team has done an exceptional job expanding reach, deepening prescriber engagement, conviction and prescription pull through. Given this outstanding momentum, we are raising our full year 2025 net sales revenue guidance for IBSRELA to $250,000,000 to $260,000,000 a meaningful step forward as we scale the opportunity ahead for this important medicine. Exposure posted a very encouraging quarter as well.

Speaker 2

With a changed market landscape, Exposure recorded net sales revenue of $25,000,000 up 7% compared to the first quarter this year and when adjusted for the one time reserve that was released in Q1, net sales grew 27. This performance speaks volumes about the strength and agility of Exposa team as they help guide healthcare providers through this changed landscape. Our Q2 results further strengthens our conviction for the significant opportunity we have ahead as we drive continued growth for Exposa. Notably, our strong commercial execution and continued disciplined investments in our business has resulted in a meaningful quarter over quarter improvement in net loss as well. Additionally, we strengthened our balance sheet and further enhanced our financial flexibility by drawing additional $50,000,000 of debt.

Speaker 2

As we progressed, we've also thoughtfully scaled the organization and we've been deliberate in strengthening our leadership team to match the opportunity ahead. Over the past eighteen months, we've added transformative talent that will help guide us into our next phase of growth. We recently promoted promoted Mike Kelleher to Chief Business Officer and appointed Laura Williams as Chief Patient Officer. We also welcomed three dynamic and experienced leaders to our executive team. Ed Connor as Chief Medical Officer, John Bishop as Chief Technical Operations Officer, and Jamie Brady as Chief Human Resources Officer.

Speaker 2

This group brings deep expertise, vision and executional excellence, exactly what we need as we execute on our ambition to create a significant enterprise and build a company of lasting impact. As you also saw in the press release we issued early today, Justin Rents, our Chief Financial and Operations Officer will be leaving the company. Justin has been instrumental in Ardellix's journey, leading with strength, goodwill, and purpose through periods above challenge and transformation. He has built a world class finance organization and positioned us to thrive going forward. We are incredibly grateful to Justin and that he will remain with us to ensure a seamless leadership transition.

Speaker 2

Justin, thank you for your partnership, your leadership and your unwavering commitment to our mission. Our Delta stronger, more focused and energized by the opportunities ahead. We are united by a deep commitment to patients backed by best in class science and guided by a team that knows how to execute. Our therapies are making a real difference. Our strategy is working and we are well positioned to deliver even greater impact moving forward.

Speaker 2

With that, I'll hand it over to Eric to walk us through our second quarter commercial performance and how his team will drive continued success to the 2025 and into the future. Eric? Thank you, Mike. It's great to

Speaker 3

be with you today, and I'm excited to share insights into the performance we delivered during the second quarter and how we plan to maintain that momentum for the remainder of the year. Let me start with Ibsrela. Ibsrela recorded an impressive $65,000,000 in net sales revenue for Q2, demonstrating 84% year over year growth and 46% quarter over quarter growth. We saw a clear acceleration in demand, delivering our strongest quarter since launch, supported by growth across all key demand indicators compared to the first quarter of this year. This performance was driven by focused commercial execution, which generated growth in both breadth and depth of prescribing and an improvement in prescription pull through.

Speaker 3

Let me dive into it a bit more, starting with commercial execution. During the quarter, the team drove significant increases in new and total prescriptions through increased field activities to targeted HCPs. We also deployed highly effective marketing activities, including peer to peer HCP education programs and digital HCP and consumer engagement. By focusing on increasing the breadth of riders, we generated growth in new riders, new prescriptions and new patient starts. In addition, existing riders expanded their view of patients they consider candidates for IBSRELA and in turn increased their depth of prescribing.

Speaker 3

We were also pleased to see that refills made up a greater proportion of prescriptions in q two, which means new prescriptions are spinning off more refills. Both new and refill prescriptions reached all time highs. We also saw early evidence that the investment in the field access manager team is having a positive impact on our prescription pull through. The team focused on educating offices to ensure that providers can navigate the access landscape if needed. We're seeing early indicators that approval rates and resubmission rates are improving.

Speaker 3

It is still early for the field access manager team, but we are pleased with the progress and results to date. It has been three full quarters since we completed our sales force expansion and the field team is hitting their stride. In the second half, they will continue their focus on target HCPs and reinforce Ibsrela's unique and differentiated position as the next choice therapy after trial with a secretagogue. We know that only a quarter of patients on a secretagogue are satisfied and there remains significant opportunity in the market. We will continue the sales and marketing activities that drove increased demand during the 2025 with the aim of continuing to expand both depth and breadth of the prescribing base.

Speaker 3

Additionally, our expanded field access team will maintain their focus on improving prescription pull through to help ensure that all appropriate patients prescribed Libtrela get on treatment. Working with Ardellix Assist, our team is focused on supporting HCPs to understand the channels that are best equipped to handle prescriptions. The field access manager team also works closely with HCPs to provide prior authorization support to improve patient pull through. Coming off a strong Q2 performance, I have full confidence in our team. Ibsrela is an important medicine that delivers meaningful benefits to patients, and our commercial strategy is working.

Speaker 3

As we look to the second half of the year, we remain focused on executing at a high level and expect our strong momentum to continue. We are raising our guidance for this year. We are confident in our ability to deliver peak sales of more than $1,000,000,000 Now on to Exposa. We are very pleased with the performance that Exposa delivered in the second quarter, delivering $25,000,000 in net product sales revenue, a 27% increase over the first quarter of this year when the onetime Q1 reserve release is excluded, driven by meaningful demand growth. Exposa is an important medicine to help patients achieve target phosphorus levels, and our strategy providing broad based patient access to Exposa regardless of payer and increasing support for prescription pull through is working in the new market environment for phosphate management.

Speaker 3

We are seeing growth across all key demand indicators, including improved access for patients on both patient assistance and paid prescriptions, as well as growth in our non Medicare payer segments, the total number of riders and new and refill prescriptions. Demand accelerated during the quarter, and we are confident we have the right strategy in place to continue to drive growth in the 2025. Taking a closer look at some of the factors behind the Q2 results. This market, like Ipsrel, is responsive to the promotional messaging from our field based area business directors and our marketing efforts. Since the beginning of the year, the field and marketing teams have been focused on ensuring HCPs understand the access path for Exposa, and we are seeing positive signs that this messaging is resonating.

Speaker 3

Total dispensers, including both patient assistance and paid prescriptions, have increased from the prior quarter as well as the total number of riders. These are positive indicators that give us confidence that our strategy and messaging are generating clarity and confidence in prescribing. Core to our strategy is driving prescriptions to our Delix Assist in order to support patients and providers as they navigate access landscape in this new environment. During the second quarter, we saw growth in the percentage of prescriptions growing through our Delix Assist and the number of target HCPs who have had a patient successfully access Exposa through our Delix Assist. Both are strong indicators that we're gaining momentum in this new environment.

Speaker 3

We have grown the total number of paid prescriptions month over month since March, and we are focused on continuing that steady and consistent growth for the remainder of the year by generating greater depth and breadth in prescribing among Exposa writers. To support patient access, we will continue to engage and partner with leadership teams and dialysis providers on ways to educate and support access to Exposa. Finally, on patient pull through, we will continue to support HCPs and patients in their prior authorization and pull through needs. Our DelixAssist plays an integral role regardless of payer, and we remain committed to patient access for the long term. As you can see, the Exposa team is focused in the right areas and we are delivering strong results.

Speaker 3

We know there continues to be a significant unmet need among patients with elevated phosphorus despite treatment with binders and we seek to deliver on that opportunity. As such, we remain confident in our ability to achieve peak sales of $750,000,000 It was a strong quarter for both Ibsrela and Exposa. The team is focused and executing at the highest level, generating increased demand and improvements in patient pull through. We are optimistic about the remainder of 2025, and we look forward to continued growth throughout the year. I will now turn it over to Justin.

Speaker 3

Justin?

Speaker 4

Thanks, Eric. Before jumping into the financials from the quarter, I wanted to take a moment to share my thoughts on leaving Ardellix later this year. I have had the privilege of seeing the evolution of Ardellix over the past five years. As many of you who have followed us for a long time now, there have been some challenges, but there have been many more successes. During my time at Ardellix, I've had the opportunity to help launch two drugs, build a supply chain support systems designed to ensure the product was always available for patients, navigate challenging financial markets, and what I'm most proud of, build a team capable and equipped to support the future operations for this company.

Speaker 4

After establishing the infrastructure required to be a successful commercial company, Ardellix is in a strong position, and it seems like the right time for me to make a transition. I look forward to staying on to help with the smooth transition of the finance leadership for the company. Ardellix is a great company with an exciting future, and I look forward to continuing to follow the company's future successes after my departure. Now onto the strong financial performance we delivered during the second quarter ended 06/30/2025. As Mike and Eric both shared, we generated significant patient demand during the second quarter.

Speaker 4

We have continued to thoughtfully invest in our business to support that growth and finished Q2 with improvement in net loss on a quarter over quarter basis. This performance reinforces our confidence in our ability to continue to generate significant revenue and carefully structure and manage our cost base. We shared our full financials in the press release and eight ks issued earlier today. I will not go into all of the individual items, but instead focus on the key drivers during the quarter, starting with revenue. For the period ended 06/30/2025, we reported total revenue of $97,700,000 an increase of 33% compared to the $73,200,000 we reported in Q2 of last year.

Speaker 4

The growth was driven by significant increases in revenue by ObsElla and product supply sales to our collaboration partners. During the 2025, we recorded ObsElla net product sales revenue of $65,000,000 an increase of 84% over the same period last year. IBSRELLA has demonstrated consistent growth since launch and our strong performance in the second quarter was a reflection of the continued patient demand. We also saw an improvement in our gross to net deductions during Q2 compared to the first quarter due to increased costs associated with our commercial co pay program. We finished the second quarter with a gross net deduction of approximately 32.2%.

Speaker 4

We expect EXPAREL to continue its strong performance for the remainder of 2025. And as such, we are raising our guidance and currently expect to finish the year with between $250,000,000 and $260,000,000 in net product sales revenue. We expect this growth to be driven by patient demand and improved prescription pull through as well as modest improvements in our gross to net deduction. Exposa also had a very encouraging performance recording $25,000,000 in sales during the 2025, which we delivered despite the loss of our largest payer, Medicare, compared to $37,100,000 we recorded during the second quarter of last year. The $25,000,000 per exposure we reported for Q2 reflects a 7% increase in net sales revenue from 2025, driven by patient demand.

Speaker 4

As a reminder, our first quarter Exposure net sales revenue included a $3,800,000 returns reserve release. Excluding the reserve release, we delivered a 27% increase in net sales revenue compared to 2025. Our gross to net deduction was 29 for Exposa, in line with our first quarter gross to net of approximately 31% when one excludes the Q1 returns reserve release. Looking ahead, the signals we are seeing are very encouraging. The Exposa strategy is working.

Speaker 4

We've established its place in a new market environment and the business is positioned for further growth in the second half of the year driven by patient demand. In addition to product sales, we also recorded more than $6,000,000 in product supply revenue related to sales to our international commercialization partners. Now turning to expenses. R and D expenses were $15,700,000 for the 2025 compared to $12,800,000 for the same quarter of the prior year. And SG and A expenses were in line with our expectations at $84,000,000 compared to $64,700,000 we reported in the second quarter of last year.

Speaker 4

The increase in SG and A was related to our continued investment in commercial activities for IBSRELA and EXPOSA, including the IBSRELA sales force expansion as well as growth of the overall corporate infrastructure to support our strategy. We expect our SG and A run rate to increase to approximately $90,000,000 on a quarterly basis for the remainder of the year with incremental increases each quarter. In the 2025, we also had $11,700,000 in non cash stock compensation expense and $2,200,000 in non cash interest expense. I would also note that we satisfied our $75,000,000 total royalty obligation to AstraZeneca during the second quarter. This obligation is now complete.

Speaker 4

We've already seen an improvement to our gross margin since May. We had a net loss of approximately $19,100,000 or $08 per share in the second quarter compared to a net loss of $16,500,000 or $0.07 per share in the same period of last year. It should be noted that this is a significant improvement compared to the 2025 when we reported a net loss of $41,000,000 or $0.17 per share. With respect to cash, we ended the second quarter with $238,500,000 of cash, cash equivalents and short term investments. This includes $48,700,000 of incremental debt from our partners at SLR Capital.

Speaker 4

At a favorable interest rate of 8.7%, we believe this was a prudent opportunity to further strengthen our balance sheet and brings our current outstanding debt to $200,000,000 with a blended interest rate of approximately 9.67% interest only through 06/30/2028. We also have the option for an additional $100,000,000 in February tranches through next year. We believe that the performance in the second quarter demonstrates our commitment to growing the top line while focusing on the bottom line. We remain committed to achieving the peak net sales revenue opportunities that we see for both of our commercial products totaling more than $1,750,000,000 thoughtfully investing in our business and maximizing shareholder value. And with that, I'll hand it back to Mike.

Speaker 2

Thanks, Eric, and thank you, Justin. I hope that what you've taken away from our call today is that the performance is an indication of what you can expect from us, a focus on execution, continued momentum and delivering on our priorities. I'd like to say a note of thanks to everyone on team Ardellix for your hard work and commitment to bring our important medicines to patients. Thank you also to our shareholders for your continued trust and support. I will now open the call to questions.

Speaker 2

Elvis?

Speaker 5

Thank you.

Operator

Our first question comes from Louise Chen from Scotiabank. Please go ahead.

Speaker 6

Hi, congratulations on the quarter and thanks for taking my questions here. I had two for you. Number one, I wanted to ask you if there was any update on a potential EU partner. And then secondly, I wanted to ask you how you're thinking about getting the cash flow positive? Is it a near term or medium term goal for you?

Speaker 6

Thank you.

Speaker 2

Hi Louise, how are you? Listen, the second part of your questions first is obviously we always go to cash flow breakeven and free cash flow in order to reinvest in the business. That's clearly an important thing. I think you can do the math with the guidance that we've given and see that it's not that far off on horizon. In terms of EU, we're going to continue to evaluate opportunities.

Speaker 2

You look at both of these businesses as it relates to Europe. And let's not even think about the halo, negative halo of MFN over making those decisions. You know, there's nothing really substantive to talk about in terms of those opportunities at this stage.

Speaker 3

Thank you.

Operator

Our next question comes from Dennis Deng from Jefferies and Company.

Speaker 7

I have two, if I may. One is on Ipsorrelis. So talk about the new guidance and what's factored into that. It seems a little bit conservative given the demand in scripts that we're seeing and also the fact that $8,000,000 about $10,000,000 raise came from the Q2B. So I'm wondering if there's anything that we are not thinking about, but you're seeing on the ground.

Speaker 7

And then my second question is on Exposite. Can you remind us what the gross to net was in q two? I think you may have said 29%, which is surprising given that's better than q one, but you are booking only commercial and Medicaid revenue in Q2 which have worse gross to net than Medicare. So how are you thinking about gross to net for the second half of the year?

Speaker 2

Sure. I'll have Justin address that. Thank you, Dennis for the questions. I'll have Justin address the second in a minute. With the first, you should know us well enough by now that when we give numbers, we are thoughtful and deliberate about what we say.

Speaker 2

Nothing to read into this except that that $10,000,000 increase in our guidance is a meaningful step in the right direction of what this opportunity is. And I think should put little doubt in people's minds about our long term projections the opportunity for this business. So I would focus on that and with opportunity to give you more perspective on how we believe this year will play out, we certainly will provide that. Does anyone provide some perspective on Q2 gross net?

Speaker 4

Thanks Dennis. So you're correct in Q1 when one excludes that one time returns reserve release we did, our gross net would have been approximately 31%. And for Q2, was approximately 29%. It does pertain to product mix, right, patient mix and the payer is. So those are pretty close to each other.

Speaker 4

There's really mild differences. We did have an improvement in commercial co pay. That was the primary driver. Again, co pay for both of our products typically improves over the course of the year. Many of our patients are on what I'll call calendar year health care plans.

Speaker 4

So if if they're commercial patients, they may have a higher deductible in beginning part of the year and it improves for them as a patient over time. So the primary difference between q one and q two is on the amount of commercial co pay that we need to, again, help the patient and patient assistance. I would look for it to be in that 30% range in general for the rest of this year. Again, 29 to 31 is a reasonable range, and we're still warning, you know, in the the new environment, there might be minor changes here and there, I expect it to be in that general range.

Speaker 7

Thank you.

Operator

Next we have Ryan Deschner from Raymond James.

Speaker 2

Hi. Thanks for the question and congrats on the quarter. I'm curious how much of this quarter the XERALIS sales growth do you attribute to expanded sales team now that it's firing on all cylinders and you've got three full quarters in. Do you expect continued meaningful script pull through acceleration into 2026 due to this expanded field team or will that start to taper off around that time? Thanks.

Speaker 2

Thanks for the question, Ryan. Let me ask Eric to address that and certainly it's not only on the sales side with the APDs, but the field access managers that Eric has spoken of that

Speaker 3

you can address that too. Yeah, thanks. Thanks Ron for the question. As I said in my earlier comments, we're three full quarters post completion of the expansion. So obviously with increased call activity, we're seeing significant increase in terms of number of riders leading to increase in new and refill prescriptions.

Speaker 3

We expect that to continue. Just to remind you, I mean, there's significant opportunity in this market. Only a quarter of patients we know are satisfied in this large market with being on therapy with the secretagogue. So we feel very confident in the opportunity that's in front of us. With this increased activity, we certainly expect it to continue for the remainder of the year.

Speaker 5

Thank you very much.

Speaker 2

And as a quick follow-up, just wanted to see how you're thinking about one quarter sort of seasonality going forward, how we should think about that over the next few years? Thanks. Sure. I'll ask Eric to provide some more perspective on it. You know, I I think as we spoke about in the first quarter, it's the first time we saw it in the way that we did.

Speaker 2

And as this business grows and the magnitude of of that impact is there, I think it's something that's prudent to have in there. Eric?

Speaker 3

Yeah. Like I said, we're very confident in our results at this point. We wanna make sure we're mindful of the summer months and we don't get ahead of ourselves. So really confident about our performance at this point in the year and certainly look forward to being able to to move into back half of this year. We know that, you know, primarily, we do see that seasonality in q one.

Speaker 3

I think for us as we move into the back half of this year, it's more just being making sure that we're recognizing what's going on during the summer months where you have more vacations. You know, physicians are taking vacations. Patients are taking vacations. You've got return to school that happens in in August. And then really things start to pick back up towards the end of the quarter as they move into as they move into fourth quarter.

Speaker 3

So for us, we're very confident at things at this point in time. We'll be mindful of those, you know, those events as we go through this quarter and feel really confident about how we're gonna be able to finish things up.

Speaker 2

Thank you very much. Thanks, Ryan.

Operator

Our next question comes from Julien Harrison of BTIG.

Speaker 8

Hi, congrats on the quarter and thanks for taking the questions. On Exposa, apologies if I missed it. Wondering if there was any contribution from transitional scripts in 2Q or are we completely past that now? And then on Ipsprella, do you have any sense for how uptake in the first line setting Are you seeing any traction there?

Speaker 8

Did you promote use at all in that setting or is that something typically just happening on its own right now?

Speaker 2

Sure. Let me address the first part of your question on expose transition scripts. You know, there was an inconsequential amount there and how long that last, you know, that's something we're not really taking a whole lot of stance on. So, you know, generally it's about fifty fifty in the overall mix between Medicaid and commercial. It's the way to think about it.

Speaker 2

In terms of first line

Speaker 3

therapy, John? Yes, good question. Thank you for that Julien. Yes, first line therapy, certainly we are aware of some of that. I think as you look at our positioning kind of post use with a secretagogue and having significant opportunity there, we feel very confident in our positioning there.

Speaker 3

I think as physicians continue to get confident in the Entrela and the impact that it can have for patients, certainly they may go to that earlier than what they're used to going to that they're what they're used to going to. And it is important to note our indication is for first line use. So it's more than appropriate for physicians to go to that first line. And for us, it's about making sure that we have patient access. So if they're able to get it first line and they have confidence in the product for the patient and it's the right choice, they should be able to get it.

Speaker 3

If it's post use with the secretagogue, again, we've got focus there on patient pull through and very confident in the improvements that we're seeing there and expect that to continue for the remainder of the year.

Speaker 8

Excellent. Thank you and congrats again.

Speaker 2

Thanks, Julian.

Operator

Up next, have Joseph Tellme from P. A. Cowen.

Speaker 5

Hi there. Good afternoon. Thank you for taking my questions. Congrats on the progress and best wishes to Justin on his next steps. Maybe on the pull down of the $50,000,000 can you go into a little bit more detail as to what triggered that outside of the favorable interest rate dynamics?

Speaker 5

And maybe when you think about that remaining 100, what would be sort of the triggers to pull the rest down? Obviously, you instituted the new CMO. Should we be thinking about this as sort of opportunistic BD or kind of building up the pipeline at all or kind of what would you be using this cash for?

Speaker 2

Thank you. A quick comment then I'll ask Justin to mention, know, SLR Solar has been a phenomenal partner of ours and you know, with the opportunity at this, it's something that just made sense to strengthen the balance sheet as I said in my opening comments. Justin, any other adds?

Speaker 4

Yes. Thanks Mike and thanks Joe. Again, hopefully you've seen over time we try to be very thoughtful and strategic with any of our fundraising initiatives, debt, equity and otherwise. Cost of capital is always important to us and be mindful of our shareholders. The debt presented itself at a very favorable interest rate, so we thought it was a prudent opportunity for us to take advantage of that and give us some near term flexibility.

Speaker 4

So looking ahead, you know, again, it's always important for us to have optionality for our team. So we will never do anything just to do anything, but it's nice to have that flexibility and optionality going forward.

Speaker 5

And maybe just some more if I if I may. Do you think that both of the sales teams are now right sized to meet your kind of peak guidance that you've set out for both Exposa and Amzarella? Or when's the right time to kind of reassess if you're at the right size?

Speaker 2

Thank you. Yes. Just one quick comment from me, and I'll ask Garrett to step in is we are always assessing how best to optimize our footprint and what we're doing. So that should never stop. I think we are pretty confident in terms of where we are in right size, but Eric anything to add?

Speaker 3

Yeah, thanks Joe. Yeah, Pretty confident in terms of where we are with the Dzirella. You know, just a reminder, we're coming off our three highest quarters of demand. So we feel like the the the team is really hitting their stride in addition to the expansion of the field access manager. So focusing on improvements in the middle of the funnel to be able to improve access.

Speaker 3

So I think right now, as we look at the sizing of our teams, we feel very confident where it is. To Mike's point, we are always assessing to look for opportunities to be able to drive incremental demand. But we also have our marketing activities that are out there. As I mentioned earlier, highly impactful marketing activities that supplement the field force activity, right, that's out there. On the exposure side, you know, as we said since the beginning of the year, it's about patient access and physicians now differentiate between Medicare or non Medicare segments.

Speaker 3

And so we're focused on the same number of nephrologists that we were focused on last year. And as you can see by some of the numbers and the improvements and the demand indicators from q one to q two, certainly feel like their efforts are appropriate and having impact with those physicians that we're targeting. And so right now, feel really good about the sizing that we have for that team as well.

Speaker 5

Great. Thank you so much. Thanks, Joe.

Operator

Our next question comes from Yigal from Citigroup.

Speaker 9

Hi, this is John Kim on for Yigal. Congrats on the quarter and thanks for taking my question. Maybe just two quick ones from us. We were wondering if there's any color at all you could provide on the breakdown of new patients versus refills and prescriptions for XERVILLA?

Speaker 2

Yeah, we've not historically given a whole lot of detail around that. I think as you heard in Eric's comments, we have seen a good amount of increase in in refill which is exactly we wanna see, you know, these patients be sticky and with the benefit these medicines are providing. So we like to see that trend. Mean the specifics we have not historically given those details. Anything to add?

Speaker 3

No, nothing more to add there. Just about making sure that the patient's going to the right channel to be able to get the product. And with that, you know, we saw more refills this quarter than we have seen, in the past, certainly versus new prescriptions. That again is just another indicator that gives us confidence in terms of, what we're able to achieve with the trial.

Speaker 9

Gotcha. Very encouraging. And if I may just one more question. Is there any update or what is the latest update in terms of the ongoing CMS legal proceedings?

Speaker 2

Yeah. I mean, as you can imagine, we've gotten out of the business of trying to predict the administration government. But, you know, we have our case will be arguments will be September 25. There's no statutory requirement for when we get a response back and as soon as we know anything of substance, we certainly will provide that for all of you.

Speaker 9

Great. Congrats on the quarter again and thanks so much. Thank

Speaker 2

you.

Operator

Our next question comes from Laura Chico from Wedbush Securities.

Speaker 10

I've got to start out with a shout out to Justin. Best of luck, Justin. Sorry to see you leaving. But congrats on the quarter. And I guess one on Exposa.

Speaker 10

Now there's been a couple of quarters in the new reimbursement environment. Just wondering, Mike, if you can kind of recalibrate it for us and just tell us what gives you confidence in the new peak estimate for Exposa that you're seeing now in this reimbursement environment? And when might you be in a position to restore guidance for Exposa? Thanks very much.

Speaker 2

Yes, for the question, Laura. And thank you for the shout out to Justin. Clearly that is well earned and appropriate. In terms of guidance for Exposa, will provide it. As we said in our comments, we saw a month over month growth since March and I would like a little bit more consistency before we get out there with numbers for you.

Speaker 2

As you can imagine, we continue to be thoughtful about what we say and when we say it. You know, for me that question that you asked the beginning in terms of what gives me confidence is with a total available market of 220,000 patients which is basically what we are now given that's the non Medicare segment. You know, the math is pretty straightforward as you look at our guidance of $750,000,000 with a number of scripts if you use binder script refills, you use our WAC with modest price increases over time. You know, it's substantively less than a 100,000 patients that gets you to that seven fifty million dollars. So I've got great confidence in this trajectory and the performance that we're seeing here and our commitment to the patients.

Speaker 2

I have great faith in the in Exposure team and Eric the pull through work that the fans are doing across the board. The marketing efforts, the entire Exposure team is focused on what's doing right for these patients. And as a result, I we writ large have great confidence in that number that we provided.

Speaker 10

That's helpful, Mike. And maybe just one last one on Ibsrela. I don't know if you'll be able to answer this, but what is the average duration on treatment now for a patient there? Thanks very much guys.

Speaker 2

Sure. I mean, I think the average duration for IBS C scripts is about five. And, you know, we're trending the same if not a little bit better. So, you know, I feel very good about the refill rates that we're seeing here just given it tends to be a disease of the experience the patients have is somewhat waxing, remitting and, you know, that has been historically the case. And we'll see if that is the case with us or if it's a tachyphylaxis you see with the GCC agonists.

Speaker 2

That's the sort of thing that we pay close attention to.

Speaker 10

Very helpful. Thanks guys.

Speaker 2

Thanks Laura.

Operator

Next we have Prakhar Agrawal from Cantor Fitzgerald.

Speaker 11

Hi, thank you for taking my questions and congrats on the quarter. So first on Ibsrela, you commented on typical summer seasonality, but seems like the 3Q script trends are also looking good. So maybe just comment on how do you see Ibsrela trends for the rest of the year and just the market overall. If you look at some of the prior year trends, second half in aggregate tends to be much stronger than first half. So should this year be any different?

Speaker 11

And just had a quick follow-up.

Speaker 2

Yes, Prakhar, thank you for the question. As I said at the start with the first question I got was what do we think about this two fifty to two sixty comparative performance exactly what you just described. With an opportunity to provide you more perspective as we go through the rest of the year, we certainly will do that. This is a meaningful step for us to give a $10,000,000 increase in our guidance. We haven't done that before in this way.

Speaker 2

So we are going to take mindful and thoughtful steps as we see the performance show itself and, you know, the data that you look at historically, you just described, sure. I can't argue against that and we will provide more perspective as we can going forward.

Speaker 11

Thank you. And relies on exposure, realize you're not providing the guidance, but consensus is sitting at 90,000,000 99,000,000 for the full year. So maybe just if you could comment on your comfort on where the street at estimates are for Exposure for the full year? And would you expect sequential quarterly growth for Exposure for rest of the year? Thank you.

Speaker 2

Yes. Nice question, Peter. You'd corner me into giving guidance. But I won't bite on all of it. What I will bite on is, you know, we just scored a $25,000,000 quarter that we've said is based upon true real demand on the non Medicare population.

Speaker 2

And, you know, do the math if it was flat and not much gets us to exactly the kind of modest growth that you would need. So I feel very good about the trajectory that we're on. And I feel confident that we will not do this in future be able to provide you some guidance. You know, With growth since March, I'm going to be thoughtful about doing that because I don't want to get ahead of myself or any of us ahead of our skis and what we're trying to do. So that's why we're sticking to our guns and not providing guidance yet, but we will.

Speaker 12

Thank you.

Operator

Next, have Aidan Husenov from Ladenburg Thalmann.

Speaker 12

Hi. Good afternoon, congratulations for the strong quarter, actual record quarter for Thrilla, I think. So let me ask you a general question first. So you're now, like, almost on track to generate 400,000,000 a year, and you only traded at billion dollar valuation. So, you know, one can imagine that you might be approached by larger players.

Speaker 12

And if you do, where do you see the potential acquirers interest? More in GI space or in the renal space? And this is obviously a very hypothetical question, but do you think you're valid more on GI or on the renal side? Thank you.

Speaker 2

You know, you guys are the sell side, you tell me. You know, I I I clearly think we're undervalued on both sides of the equation whether $750,000,000 peak for Exposa or a billion or more on Exposa, we're undervalued. And, you know, whether it's because people find show me story for Exposa and I think we're showing everyone or that Idrella and the GI market's hard to understand. I can't understand that because it's pretty straightforward with what we're doing in our performance. So, you know, our objective here is to build a great company and a sustainable enterprise.

Speaker 2

And, you know, I'm less interested in how other people think of us in terms of bigger companies out there versus ultimately the patients that we're here to serve.

Speaker 12

Thank you. Appreciate you answer. Thank you.

Operator

Our next question comes from Allison Pratzel from Piper Sandler.

Speaker 13

Hi. This is Ashley on for Allison. Congrats on the great quarter, guys. I just had two questions. One for Exposa.

Speaker 13

I know this is already asked in terms of guidance, but if there's anything that you can point us to in terms of what you're hoping to see in terms of any specific metrics or indicators that would give you the confidence to provide guidance maybe in the second half of the year, that would be really helpful. And then second, on your licensing revenue and product supply revenue and noncash royalty revenue from your partners, we're seeing some really good growth on that front. So just wondering what that could look like in the second half of the year or if you have any expectations? Thanks.

Speaker 2

Sure. Just on rest of side, good question in a minute. For your first one, it's frankly more of the same, right? If you look at what we've done, Q1 with all the peculiarities we saw there and uncertainties that people had. I think what we've shown everyone in Q2 is the trust us.

Speaker 2

Our strategy is right and we're serving these patients who really need better phosphorus control. So I think that's unequivocal. I'm thoughtful we are conservative and mindful of the way we give guidance and I think it's seeing more of the same honestly as we navigate this quarter and into next to gain the confidence provide you some guidance. Justin?

Speaker 4

Thank you. So we do generate product supply revenue from our three international collaborative collaborative partners. We did have a good second quarter, as you noted, just over $6,000,000. So our partners ordered from us, you know, quasi regularly, but not quarterly. So we do expect some additional revenue from our partners in the fourth fourth quarter of this year and be relatively comparable to the quarter we just had.

Speaker 4

So I would model limited in q three. And then 2026, haven't gotten to yet because they haven't placed their orders yet. And then on the our partner's gonna do well. Kiowa Kirin is doing well in Japan with their sales for hyperphosphatemia. We did monetize that royalty stream with our partners and health care royalty partners.

Speaker 4

And so I do expect that to grow throughout this every quarter, hopefully, as Chiropurin does well in penetrating their space. They've got a very good launch. But that money is primarily passed through in full to health care royalty partners. So any modest increase you see in non cash royalty revenue is offset by a corresponding debit, if you will, into our p and l.

Speaker 13

Got it. Thanks so much, guys.

Operator

Next, we have Verona Reese from Leerink Partners.

Speaker 14

Hi, Allison. Maisie on for Roana. Just one from us. Sorry if it's been asked already, but can you provide more granular detail on the current prescription mix between Medicare PAP and revenue generating non Medicare patients for Exposa? And how do you expect this to evolve throughout the remainder of '25?

Speaker 2

Great question. So we don't talk about the number of scripts that are non revenue as we've not done that historically. But for Medicaid and commercial for Exposa, roughly fifty fifty is turning out the way we expected it to.

Speaker 5

Fantastic. Thanks. Thank you.

Operator

That concludes our question and answer session. Michael, I'll turn things back over to you for any additional or closing comments.

Speaker 2

Excellent. And thank you all for joining us this afternoon. We are as ever focused on our vision of a healthier tomorrow for patients and to maximizing shareholder value. With that, we can close the call.

Operator

Thank you, Elvis. That concludes our meeting today. You may now disconnect.

Powered by Quartr