Q1 2024 Ardelyx Inc Earnings Call
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Good day and welcome to the art of looks first quarter 'twenty 'twenty four earnings call. All participants will be in listen only mode should you need assistance. Please signal a conference specialist by pressing the Starkey followed by zero.
After todays presentation, there will be an opportunity to ask questions. Please note. This event is being recorded I would now like to turn the conference over to Caitlin Laue, Vice President of corporate Communications and Investor Relations at <unk>. Please go ahead.
Caitlin Lowie: Thank you good afternoon welcome to our first quarter 2024 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 and our golf Dot com during.
Caitlin Lowie: During this call, we'll be making forward looking statements that are subject to risks and uncertainties.
Caitlin Lowie: <unk> results may differ materially.
Caitlin Lowie: We encourage you to review the risk factors in our most recent quarterly report on Form 10-Q that was filed today can be found on our website and our doubts dot com.
Caitlin Lowie: While we may elect to update these forward looking statements in the future.
Caitlin Lowie: We disclaim any obligation to do so even if our views change.
Caitlin Lowie: Our president and CEO, Mike Raab will begin today's call with opening remarks, and an overview of the company's progress during the first quarter of 2024.
Speaker Change: We get the Chief commercial officer provide an update on the performance Venezuela.
Speaker Change: Dunkin' brands, Chief financial and operations Officer will conclude today's prepared remarks with a review of the Companys financial performance. During the first quarter ended March 31, 2024 for me open the call to questions.
Michael G. Raab: With that let me pass the call over to Mike.
Michael G. Raab: Good afternoon, everyone and thank you for joining us on this call Q1 earnings always seem to come quickly. After we report our Q4 results and yet as usual a lot has happened since we last provided you an update.
Mike: Exposes performance out of the gate following the launch November continues at a remarkable pace.
Mike: This is a first in class product therapeutic area that has seen no innovation in decades.
Mike: The response from the prescribing community clearly demonstrates the significant unmet need among this patient population.
Mike: <unk> is an important new option for physicians to help patients with serum phosphorous remains elevated despite best efforts.
Mike: All demand indicators are favorable prescribers are eager to learn more about expose blocking mechanism and are working to identify potential candidates for therapy.
Mike: Mike its rollout our delek assistant supporting prior authorizations, and helping patients take advantage of our pardon ability programs.
Mike: Patients are accessing the drug and the feedback is that patients are seeing sustained reductions in their serum phosphorus.
Mike: We are focused on ensuring prescribers are aware and educated on exposure and ensuring patients have access to treatment.
Mike: As you can see by our performance.
Michael G. Raab: Going very well.
Michael G. Raab: It's Raleigh continues to perform strongly providing an important option to again address a large unmet need among ibs C. Patients. We believe that this can be a $1 billion product and on the path to achieving that we.
Michael G. Raab: We expect full year net sales revenue for 2024 to be between $140 million to $150 million.
Michael G. Raab: As I consider the first quarter performance, the underlying demand metrics and fundamentals of the business are robust and continue to demonstrate growth in new and repeat writers and new and refill prescriptions.
Michael G. Raab: Our reported revenue reflects demand growth offset by the impact of seasonality, which is standard across the industry than we experienced during this first quarter.
Michael G. Raab: Importantly, our cash position remains strong resulting from our revenue.
Michael G. Raab: The third tranche of debt from our partnership with SLR and thoughtful management of our expenses.
Michael G. Raab: We are at an exciting time in our evolution as a company and our top priority is to build upon the growth momentum of its rollout and exposure.
Michael G. Raab: Now I will turn the call over to Susan to discuss first quarter performance for both of our products Susan.
Susan: Thank you Mike It is great to be here today to discuss the commercial performance sports rally and expose that our performance reflects strong execution of our disruptive commercial approach for both first in class products, which centers on targeting the high volume writers and our disease area driving identification of patients.
Susan: That's in need of a novel treatment option as their response to existing treatment options is deemed to be inadequate.
Susan: And enabling patient access and affordability with favorable coverage policies that define the path to access prior authorization support and patient support program, Let me begin with Israeli law.
Michael G. Raab: Our confidence in this product is driven by the strength of the fundamentals driving in Sterling performance.
Michael G. Raab: H C piece are evolving their treatment practice now that they have expanded treatment options for their Ibs C patients following the launch of Israel.
Michael G. Raab: Based on the favorable clinical response, they are seeing and confidence in the path to access H C piece are increasingly identifying patients in need of a novel treatment option.
Michael G. Raab: During the first quarter, we saw increases across all key demand parameters for the product, including growth in new riders and repeat writers as well as growth in new prescriptions and refill prescriptions. We are very encouraged by the continued growth of these key demand metrics. Despite Israel are being impacted my first quarter seasonality.
Michael G. Raab: Alrighty that is commonly seen across the industry linked to insurance plan resets and prior authorization renewal processes.
Michael G. Raab: During the first quarter, we began the process to expand the Bureau, a dedicated sales force footprint from 64 territory to 124 territories.
Michael G. Raab: We experienced a strong response to the job posting attracting sales talent with extensive G. I experience, who are motivated and enthusiastic to join the Israel, our sales team and be part of disrupting the Ibs C market with an innovative therapy.
Michael G. Raab: Hiring training and full deployment of this team is on track to be completed by the end of the second quarter.
Michael G. Raab: The fundamental drivers behind Israel are strong and we anticipate continued quarter over quarter growth with our expectations for the 'twenty 'twenty four performance consistent with our stated guidance.
Michael G. Raab: Turning to expose that we.
Michael G. Raab: We are extremely pleased with the nephrology community response to this first in class phosphate absorption inhibitor. It is clear that patients had been in need of a new option to manage their phosphorus when binders are insufficient or not well tolerated.
Michael G. Raab: Our dedicated nephrology sales team comprehensive blocking messaging campaign speaker and promotional programs and omni channel initiatives are driving high interest and early uptake of expose that nephrologists are responding favorably to the novel blocking mechanism and clinical data profile are pleased with.
Michael G. Raab: The early clinical experience encouraged by the defined coverage policies and increasingly integrating this novel blocking mechanism product into the therapeutic regimen for their patients.
Michael G. Raab: The feedback we regularly receive from the field is that physicians are seeing that they're exposed to treated patients many of whom had been continuously outside of target ranges are reflecting consistent improvement in serum phosphorus levels and that these levels are being maintained.
Michael G. Raab: We are also hearing that patients are responding favorably to the dosing profile and then H C piece are pleased with the flexibility they have and adapting the patient's treatment regimen.
Michael G. Raab: Where are they can add expose that to the patient's existing binder regimen or they can ask those and reduce the patient's binder regimen or they can ask those and fully discontinue the patients find your regimen H C. P. R. Adopting expose it and are adapting regimens based on the needs of the patients.
Michael G. Raab: We are very pleased that the $15 $2 million in sales, we reported for Expos that during the first quarter.
Michael G. Raab: This performance is consistent with the uptick indicators, we are seeing in the field. Our sales force is experiencing highly engaged meaningful discussion with our targeting C. P who are eager to learn about expose that nephrology H D piece are rapidly identifying patients who they believe can benefit from therapy reporting to us that they may have many.
Michael G. Raab: Patients outside of target ranges, despite treatment with binders or are intolerant of binder therapy.
Michael G. Raab: ACP, they're pleased with the clinical response, they are seeing and patients are responding favorably to the treatment experience coverage policies are being defined that Atlanta path to access by our prior authorization attesting to the fact that the patient has been treated with binders and inadequately responding or unable to tolerate the therapy.
Michael G. Raab: C P. They're seeing that one prior authorizations are submitted her patients meeting the criteria patients are gaining access to expose that.
Michael G. Raab: Nephrology HCP and their office staff are responding favorably to our specialty pharmacy distribution network as well as to our comprehensive patient services offering our Dallas assist that further enable patient access through prior authorization support and patient engagement with the affordability programs available to them.
Michael G. Raab: Our own internal metrics are supported by external research conducted by sphere acts. He was tracking the launch of expose that according to the April 'twenty 'twenty four launch dynamics report nearly all of the 77 survey Nephrologist, 98%.
Michael G. Raab: Expose that as an advance over currently available Hypophosphatasia therapies. In addition, 56% of the survey Nephrologist reported using expose that and if those again, 98% report satisfaction with treatment.
Michael G. Raab: The research demonstrates that awareness is high among the nephrology community interests and intend to adopt is high and satisfaction with the treatment is high among users.
Michael G. Raab: We will continue to build upon our watch momentum capitalizing on the high nephrology awareness of the number of patients that are in need of a new treatment option, despite treatment with binders and their intent to adopt expose up where these patients.
Michael G. Raab: Our go to market strategy is working we have established a strong presence in nephrology offices across the country and H D. Peas are responding favorably to the novel blocking mechanism and clinical data profile. They are identifying patients that could benefit from extended the therapy and with coverage policies in place patients are gaining access.
Michael G. Raab: We have several exciting months ahead, as we will have a strong commercial and clinical presence across key annual medical conferences for both Israel and expose that where we will have the opportunity to present more clinical trial data on our products connect with the prescribing community and deepen our relationship with patients I look forward to continuing to share updates with you in the future.
Speaker Change: With that I will hand it suggested.
Speaker Change: Thank you Susan.
Susan: Very pleased to be with you today to discuss the first quarter performance, we reported which included meaningful progress towards our ROE and net sales revenue guidance, a strong launch of exposure careful management of refinances and a strong cash position.
Speaker Change: Let's start with revenue.
Speaker Change: As you saw in this afternoon's release, we reported significant year over year growth, bringing our total first quarter product related revenue to $45 6 million compared to $11 4 million in the first quarter of 2023.
Speaker Change: Net product sales revenue Forbes ROA was $28 4 million during the first quarter of 2024 more than doubling the $11 4 million in revenue we reported during the same period in 2023, and a 1% quarter over quarter growth compared to the fourth quarter of last year.
Speaker Change: Volume demand group rigs rollout during the first quarter, which was offset by deductions associated with the reset of annual prescription drug plans. Most notably this was related to our commercial co pay program.
Speaker Change: The impact of the commercial co pay program is most significant in the first quarter when most commercial health care plans reset and patients have higher out of pocket requirements.
Speaker Change: As patients fill prescriptions throughout the year and begin meeting their deductable requirements are expenses related to the commercial co pay program decline.
Speaker Change: Our gross to net deduction firms rollout during the first quarter was in line with our expectations at 33, 5% and comparable to the 33, 7% we saw in the first quarter of 2023.
Speaker Change: We expect this percentage to improve as the year progresses as it did last year.
Speaker Change: In addition, we saw the anticipated impact of the prior authorization renewal process that occurs at the start of the calendar year for many health care plans.
Speaker Change: Strong demand and expected improvement in gross to net deductions reinforced our confidence in the ongoing performance of withdrawal.
Speaker Change: As such we continue to expect that full year U S. <unk> net product sales revenue will be between 140 and $150 million.
Speaker Change: Exposure had an exceptional first full quarter performance as we are reporting $15 $2 million and net sales revenue driven by the meaningful demand for this product.
Speaker Change: Our gross to net deduction keven favorably for exposure at 23, 8%.
Speaker Change: As we progress into the watch the exposure and more and more about the patient mix that drives the associated gross to net deduction, we will share more.
Speaker Change: In addition, we had $2 $5 million in combined licensing and product supply revenue.
Speaker Change: We are very pleased with our top line results during the quarter, which demonstrate the growth momentum, Mike and Susan both spoke to.
Speaker Change: At the same time, we continue to be thoughtful in how we manage our expenses.
Speaker Change: Research and development expenses were $10 $6 million compared to $9 1 million during the first quarter of 2023.
Speaker Change: Selling general and administrative expenses were $53 million for the first quarter compared to $26 8 million for the same period of 2023.
Speaker Change: The increase was related to launch activity for exposure as well as continued investments to grow its rella, which remains were out last year.
Speaker Change: Importantly, our costs were comparable to our spending in the fourth quarter of 2023.
Speaker Change: We expect to complete the current expansion of being <unk> Salesforce as Susan previously mentioned by the end of the second quarter.
Speaker Change: Substantial top line growth combined with thoughtful cost management resulted in a net loss of approximately $26 $5 million or <unk> 11 per share in the first quarter of 2024 compared to a net loss of $26 $8 million or <unk> 13 per share in the same period of 2023.
Speaker Change: The net loss for the first quarter of 2024 included $9 $3 million in combined noncash expenses from share based compensation and noncash interest expense related to the sale of future royalties.
Speaker Change: As of March 31, 2024, we had total cash cash equivalents and short term investments of $202 $6 million as compared to $184 3 million at the end of 2023.
Speaker Change: This includes $49 $8 million in net proceeds that we drew in March from our term loan agreement with SLR cabinet.
Speaker Change: We are very pleased with our performance during the first quarter driving top line growth across all reported revenue lines planning for success investing in our supply chain, managing our operating expenses and strengthening our cash position.
Speaker Change: We will continue to be thoughtful with how we deploy capital while focusing on maximizing shareholder value.
Speaker Change: With that I'll turn it back to Mike.
Michael G. Raab: Thanks, Justin.
Michael G. Raab: I hope that what you took away from our performance during the first quarter is at one we continue to have high expectations for its rollout, including a $140 million to $250 million and net sales revenue this year and on the path to at least 10% market share and $1 billion in annual revenue.
Michael G. Raab: Two <unk>.
Michael G. Raab: Exposes launch progress is exceptional and.
Michael G. Raab: And it is already beginning to disrupt the hyperbolic TD market, where there remains significant unmet needs among patients and finally, we are in a strong cash position to invest in growth.
Michael G. Raab: We have a lot of important work ahead of us and we have a team in place who is able to deliver.
Speaker Change: Look forward to sharing our progress with you over the coming quarters and I will now open the call to questions operator.
Speaker Change: Thank you we will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.
Speaker Change: To withdraw your question. Please press Star then two please.
Michael G. Raab: Please limit yourself to one question and one follow up at.
Speaker Change: At this time, we will pause momentarily to assemble our roster.
Michael G. Raab: The first question comes from Chris Raymond with Piper Sandler. Please go ahead.
Christopher Joseph Raymond: Hey, Thanks, and congrats on the.
Christopher Joseph Raymond: Great success here with exposure.
Christopher Joseph Raymond: Yes, just maybe one question on that and a follow up as well I know you guys are early in the launch and you've already established sort of a cadence here for guidance.
Christopher Joseph Raymond: After having a number of quarters that you've set with a drama, but just you know the but the magnitude of this be is obviously more than any of it but he expected can you provide maybe any sort of color here.
Michael G. Raab: Hum.
Michael G. Raab: I think everybody sees the script data and if folks were following that they're even surprised those who've been following the script data closely are surprised by the number.
Michael G. Raab: Any sort of color in terms of the uptake in and what what we should be thinking in terms of you know the implications for the for the next several quarters couple of quarters anyway.
Speaker Change: And then maybe the follow up is I know, Mike you're not.
Michael G. Raab: And the business of predicting legislation, but.
Michael G. Raab: In the absence of sort of any any progress you know in terms of.
Speaker Change: Uh huh.
Michael G. Raab: Pushing the hum the phosphate binders into the bundle.
Michael G. Raab: Pushing that off.
Michael G. Raab: You know at what point do you start maybe planning for that as a reality.
Michael G. Raab: Yes.
Speaker Change: Yes, so Chris Thanks for the questions I guess first of all.
Speaker Change: I hope by now you can tell that we're not quitters.
Speaker Change: And that we see what we're doing for patients and the uptake that we see would expose us.
Speaker Change: Is it has been absolutely worth the fight that we're fighting I think as you see with what we've done with its rollout.
Speaker Change: C patients as well deserved attention that we're giving them.
Speaker Change: What you saw with its relative as we need and we expect to have roughly four quarters under our belts before we give guidance, we don't want to get over our skis, we're excited and thrilled by this performance.
Speaker Change: Anticipation for the drug out there the enthusiasm our ABTS youre seeing in the field is remarkable.
Speaker Change: The ability that we have in helping people through the prior authorization problem process through our dogs assistant working extraordinarily well based on some of the learnings that we got through with its wrong. So although I would like to use nuclear answer on both of those I'm sorry, I'm sure you understand that I can.
Speaker Change: Got it thanks.
Speaker Change: Thank you for trying.
Speaker Change: Yeah.
Speaker Change: The next question comes from Yigal <unk> with Citi. Please go ahead.
Yigal: Oh great.
Yigal: Consumes and Joseph and team. Thank you so much and congrats as well on a very strong lunch.
Yigal: Susan I just had a few questions on the commercial franchise.
Yigal: Regarding <unk> can you comment the percent the word new riders versus repeat writers in the quarter.
Yigal: And then with the almost doubling in the territories. How do you expect that to scale in terms of the size of the base of the prescribing physician community and then with expose you nicely articulated the three buckets the ones, where you add expose and get them. The goal of ones, where you can add and then reduce the binary.
Yigal: And even at exposure and potentially remove the binder altogether do you have any anecdotal or early evidence or data to discuss sort of roughly what percent are fall into each of those three scenarios. Thank you.
Yigal: Yeah.
Speaker Change: Thanks, Hey, guys. Thanks for the question in terms of the new and repeat writing them. We had we have not disclosed the specifics in terms of those percentages, but what I can tell you. That's a really important metric to track is just the persistence of new writers being generated weekly monthly quarterly.
Yigal: And what we're seeing since launch is that this has been persistent with new writers being generated.
Yigal: Constantly on a weekly monthly and quarterly basis, so seeing that persist really gives us great confidence in the momentum in our guidance for this year in terms of repeat writing well you know what what's important to note. There is that now that we're several quarters into launch we have the data to show that new writers.
Yigal: Right again, so we're seeing that repeat writing is also persistent where the growth opportunity is is in continuing to drive that new rider growth. But then also amongst that growing brighter b, it's really growing depth of writing. So these repeat writers could write more often and for more patients and what our sales forces exit.
Yigal: Heating on is really driving that broader view based on the foundation of positive experience they've had to date of patients, but now really needs to be considered as a candidate for them because they do have persistent symptoms have been tried and other things and now physicians have seen that there is a path to accessing that patients are responding well so they're broadening their view on potential candidates in that.
Speaker Change: Really an important growth opportunity for us as well in terms of the sales force impact that's exactly why you know we believed it was critical to continue to invest in our sales force footprint because our experience to date shows that the spaces.
Yigal: Promotion sensitive so the more we call on doctors the more the right Israel out we see that relationship the more they engage in all of our Omnichannel initiatives and in our program. The more Israel are they right. So so expanding our footprint from 64 224 really gives us an opportunity to get those get into those.
Yigal: HCP offices more frequently to continue to drive that expanded riding and really capitalizing on the fact that they are broadening their view on patients who are candidates for exposure and at the same time can also continue to penetrate our target space and generate new riders, so really being able to execute I'm ripping out to achieve.
Yigal: Both.
Speaker Change: Okay, Great and then if you could if you could comment on the Expos a question that says do you have any data.
Yigal: Data there regarding the the way its pocketing on that.
Yigal: Reducing the biodiversity.
Yigal: Yeah.
Yigal: Typically from a percentage standpoint, your call, but what we're hearing persistently is that all nephrology. It you know in general Nephrologists are just commenting on the flexibility and that's what's really exciting because that means that that patient group that they identify that they believe is inadequate we manage on binders or don't tolerate binders they see it.
Yigal: Expose them because of its complementary MLA blocking mechanism of action as it drives it that patient could benefit from and there and they don't have it in going concern around how it gets integrated because they can be flexible on initiating therapy and then perhaps some of them are initiating tracking and then taking them off you know some of them.
Yigal: Binder some of them just cut the binders right away some of the time. They just eliminated entirely as I mentioned in my narrative. So what we hear more is just that.
Yigal: Each doctor is actually using the drug with this level of flexibility and that they see that as a way to really be able to realize the benefits of novel mechanism expose that across their patients that they see or inadequately manish.
Yigal: And then you call. This is Mike just one additional comment with that is I think as we spoke of earlier.
Michael G. Raab: In other calls as you've never had multiple mechanisms like you do with so many other diseases to manage what the drugs are trying to address so it is not going to be a static ratio in any given patient theres going to be an inter and intra patient variability depending upon their serum phosphorus is now flexibility and tools for these physicians to finally get phosphorus in the target.
Michael G. Raab: They're looking for.
Michael G. Raab: So I think that's been evolving.
Michael G. Raab: And as we understand that better in the coming quarters, we'll certainly share it.
Speaker Change: Great. Thank you very much.
Speaker Change: Yeah.
Speaker Change: The next question comes from Louise Chen with Cantor. Please go ahead.
Louise Alesandra Chen: Hi, congratulations on all the progress this quarter and thank you for taking my questions. Here. So first question I wanted to ask you about was I suppose that in the $15 2 million is up all demand sales or was there any stocking in there and secondly, just back on this but he harder bell if it doesn't move through that is that one.
Louise Alesandra Chen: Dollars at peak sales you have the idea of thriller risk or that is regardless of whether or not but he cargo happens. Thank you.
Speaker Change: Yeah, I mean, there are two different product lines in different patient populations. So our guidance with Israel is independent of that.
Speaker Change: But thanks for asking that.
Speaker Change: As it relates to stop you, let me ask Justin to address that.
Justin: Thank you Louise.
Justin: It has been really adjust in time.
Justin: If you will approach wouldn't expose itself doing it.
Justin: Through our network, we've seen very low inventory range since launch in November So I would say it is absolutely demand of the patients and not at all any stocking very limited to roughly between one and two weeks at Max and the channel.
Justin: The next question comes from Ryan Deschner with Raymond James. Please go ahead.
Justin: Hi, This is Ryan Deschner.
Ryan Phillip Deschner: Congrats on the strong early expose the launch two good questions for me at this point I was wondering what the breakdown is looking like so far between patients getting access to expose it through Medicare versus non Medicare.
Ryan Phillip Deschner: And then comparing the.
Ryan Phillip Deschner: How much of exposes strong start are you attributing to the differences in market dynamics versus differences in your commercialization strategy in other words, yes.
Justin: Is your commercialization strategy for explosive markedly different.
Justin: From that of the earlier thriller launch or is the main driver more related to differences in things like unmet need patient right itself.
Speaker Change: Yeah, Ryan Thank you for the question.
Speaker Change: The answer is of course, it's our very very unique and disruptive commercialization approach.
Speaker Change: No kidding is I think what we do here and Susan can address in greater detail. It truly is.
Speaker Change: One about having really good drugs that are making a difference for these patients having a commercial team that knows how to communicate that beyond the channel initiatives and remarkable sales team with feet on the ground talking to physicians about what these drugs can do for their patients because these drugs work.
Speaker Change: Susan.
Susan: Yeah, So I would say exactly to Mike's point, our go to market strategy actually there are really very important parallels between Israel and expose I N. The novel MLA and the fact that there's limited options and the fact that there's patients in need of novel options, So what where I see where what's an important distinction is that for exposed.
Susan: We went into the market with a very very ingoing high level of awareness of exposure across the nephrology target base.
Susan: And high interest and intent to adopt and high level of awareness on the range of the patients that they see that they have challenges in managing serum phosphorus on binder therapies. So so I think there was a you know a higher level of market awareness about both the product and the unmet need whereas it as rolla.
Susan: While it's a parallel situation where patients have limited options that are inadequately manage and in need of a novel option in our go to market approach is really our promotion and our education on our target base that really got them to begin to identify wow, yeah patients aren't adequately manage we never had another option now that we have another option.
Susan: We're increasingly identifying these patients were actually engaging in dialogue with these patients and now we're expanding the way, we treat and using Israel up for those patients anatomy manage so there was a little bit more market need education required on the <unk> side and that those would be the only differences path to access is the same and and the coverage policy.
Susan: Okay.
Speaker Change: Got it and then on the Medicare versus non Medicare breakdown for the first quarter.
Speaker Change: Yeah.
Speaker Change: Yes, Susan Yeah, Yeah. Thank you Mike, Yes, so right now, it's actually really interesting being on the market now for a full quarter that we can see from our IQ via data what the percent mix is for the expose a prescription and on average between 55 and 60%.
Speaker Change: Medicare and the remainder is non Medicare.
Speaker Change: Got it thank you very much.
Speaker Change: Thanks, Brian.
Speaker Change: The next question comes from Dennis <unk> with Jefferies. Please go ahead.
Dennis: Hey, guys congrats on the solid quarter.
Dennis: Two questions for me if I may on gross to net for expose that this was definitely better than what people expected in the first quarter. So how does this evolve through the year and we shouldn't use the 23% to 23%.
Dennis: As the new base going forward and then secondly, I wanted to take another stab at this question, but on HR 50, Sony core.
Speaker Change: Bill is to be signed into law in the first half of 'twenty five expose the would need to go into to depth.
Speaker Change: But then the bilka sign expose our would need to come back out of South Africa can you, perhaps shed some light on that process from the logistics around that thank you.
Speaker Change: Hey, Dennis.
Speaker Change: Kelly just directly address that quickly currently I think as we've said our intent is to enter into that but I think the specifics of what you were just describing you know where that's going to play out over time.
Kelly: But our current intent is to go through the process and as we hope and the work that we're doing in Buddy Carter's doing and others on the hill is understanding how important. This medicine has for patients. This is good policy and the right thing to do to ensure that patients get access to a drug that's already beginning to make a difference in many many lives of dialysis.
Kelly: Patients. So the work continues and the specifics about how things come in and out.
Kelly: Upon these next six months or more.
Kelly: Get that to you as we also learn.
Speaker Change: And adjusted you addressed the gross net thanks, Mike Yeah, Dennis in the first quarter exposed as gross to net deduction was 23, 8%.
Speaker Change: Obviously, it's very early in the launch and also the first quarter of the calendar year, So as Susan articulated our Medicare and non Medicare split is.
Speaker Change: It's around 55% to 60% Medicare and the rest non Medicare we're still learning the patient mix. This is going to drive the gross to net ratio through the course of the year. So as a reminder, I guess and it is our first full quarter.
Speaker Change: We're currently estimating that maybe it will slightly increase over the next few quarters, but in general.
Speaker Change: And we will obviously have been more positive you have greater clarity.
Speaker Change: Okay.
Speaker Change: Got it.
Speaker Change: The next question comes from our Rwanda Ruiz with Leerink partners. Please go ahead.
Roanna Clarissa H. Ruiz: Great afternoon, everyone. One for expose Oh could you talk a bit about what the early adopter patients look like in terms of their main features and you know what.
Roanna Clarissa H. Ruiz: It's really encouraging physicians to find them and identify them as optimal candidates for expose.
Speaker Change: Yes, I'll ask Susan to address it but.
Speaker Change: The reality is there are there not that hard to find when we know up to.
Speaker Change: Patients are out of range.
Speaker Change: And they've been waiting for something like that so it isn't just the peak and fine.
Speaker Change: Ask the question do you have patients above the answers of course, yes.
Speaker Change: And then we move forward.
Speaker Change: Students sorry.
Speaker Change: Yeah, No no youre absolutely right.
Speaker Change: But I think that you know in terms of I. Appreciate your question on who are these early patients, we're getting and I think to mikes 0.1st of all important to know that these phosphorus levels are tracked very closely so nephrologist have like an ongoing understanding of their patient base and where their phosphorus is are so what we're seeing in terms of the Ah patients that are.
Speaker Change: Or being initiated on expose up right away are those that the nephrologists had in mind that they know historically, they've really had challenges in keeping them within target ranges, that's who we're getting now and what's really important as we continue to execute is is now that they they expose is available to really make sure that the nephrologist.
Speaker Change: Begins to adapt their behavior and insurance you expose that you know them you know.
Speaker Change: When possible looking at their patients that are outside of target ranges.
Speaker Change: Got it thanks.
Speaker Change: The next question comes from Laura Chico with Wedbush. Please go ahead.
Laura Kathryn Chico: Hey, guys. Good afternoon, thanks, very much for taking the questions just two for me first on address.
Laura Kathryn Chico: What needs to happen to hit the high end of our guidance range now for <unk>.
Laura Kathryn Chico: 'twenty 'twenty four and then I just wanted to follow up on expose the conversation around the current Medicare and Medicaid mix does that is that where you're projecting at a steady state level you remain kind of a roughly even split between Medicare and non Medicare patients and I've just kind of thinking ahead in terms of revenue.
Speaker Change: I mean, just briefly address is Raleigh question is its execution.
Speaker Change: Expanded footprint certainly is going to be a benefit as we said are trained and in the field by the end of the quarter. So that's certainly a big part of it too but its execution. The patients are there they're waiting and when you ask the right questions and physicians identified and then we help them go through the prior authorization.
Speaker Change: Susan you want address the sort.
Susan: Was the question.
Susan: Yeah sure. So I think just as anything regarding exposed to at this moment I only having one full quarter under our belt, it's hard to predict Laura.
Susan: Don't want to give you the impression that this is exactly steady state. However, it is not unexpected when you I'm just understanding the patient mix in the dialysis.
Susan: Setting them up and the mix that we've seen even you know for the activity of data for the binder therapies mm.
Susan: This is not unexpected, but we need a few more quarters before we can tell you for certain one thing. That's important is just understanding that the coverage policies had been defined across all the payer segment. So when I think that's really what's driving the ultimate outcome in terms of the profile. So that is it.
Susan: Tablet and will be you know consistent as we move into the you know as we proceed through this quarter and going forward since we have nice coverage policies in place across all those segments.
Speaker Change: Thanks very much.
Speaker Change: Thanks, Laura.
Joseph: The next question comes from Joseph told me with T. D. Cohen. Please go ahead.
Joseph John: Drug and then second Mike you mentioned the cash balance maybe what's your appetite to invest in R&D either internally in the pipeline or maybe go externally and bring something else. Thanks.
Speaker Change: And let me address both the person and the last question is.
Speaker Change: It's early days for us to be sharing what's on.
Speaker Change: Patient assistance program.
Michael G. Raab: So we're in a wait until we've got more experience under our belts with that and as you saw just under a month and a half ago. We hired my color her as our executive Vice President of corporate development strategy that should be the signal to your question our willingness to invest in pipeline opportunities, whether it's organic development.
Speaker Change: Or opportunities you may find them outside.
Speaker Change: So leveraging that and bringing Mike on board certainly is a big part of us going in that direction.
Speaker Change: The next question comes from Ed Arce with H three rein right. Please go ahead.
Speaker Change: Hi, everyone. This is Thomas Yip asking a couple questions for Ed Congrats on very strong Oh.
Wing Cheung Yip: Traction agreements also.
Wing Cheung Yip: Perhaps first question RK discuss how many patients are on board the brokers debates amongst the stations.
Wing Cheung Yip: The split between GR, gastro and derm PCB subscribers.
Speaker Change: Follow up question as well.
RK: Yeah, it's a little bit hard to hear the question, but I think you were asking about the split of patients in Gis versus PCP.
Speaker Change: As Susan has spoken about our targets, it's high writing Gis and high writing.
Speaker Change: Hcp's, who act as other Gi isn't that big practices I don't know Susan do you want to add anything more to that.
Susan: Yeah exactly so we identified our target audience is 9000 H C piece that account for 50% of the total Ibs C indicated market. So even though so many doctors write ibs D scripts and the.
Susan: <unk> are really targeting this concentrated group that accounts for 50% is really what drives this umbrella opportunity for us and as Mike mentioned, they you know what we find is that there really isn't a distinction between a P. C. P. N. A G. I what we have is that high writing G eyes, and then we have high writing non G I.
Speaker Change: And our go to market approach.
Speaker Change: Yeah.
Speaker Change: Got it.
Speaker Change: Also can you discuss how many patients are on the explosive breakfasted data and then also the script data.
Speaker Change: It can be a reasonable indicator of underlying demand growth.
Speaker Change: I think again, it's early days for us to be sharing that kind of information.
Speaker Change: The next question comes from Matt Kaplan with Ladenburg Thalmann. Please go ahead.
Matthew Lee Kaplan: Hey, guys. Thanks for taking my question and nice nice out of the gate launch for excellence.
Matthew Lee Kaplan: That's there.
Matthew Lee Kaplan: Just wanted to dig in a little bit more to excellent performance during the quarter I guess, what that could mean for demand in 2024 and beyond but.
Matthew Lee Kaplan: Especially given the high levels of interest you're seeing in the sphere of survey.
Speaker Change: What are these initial doctors.
Speaker Change: Kind of Oh.
Speaker Change: Adopters that that that really take a new therapies and then.
Speaker Change: Will it be more difficult to get additional adopters down the line. Because these are these are the early on.
Speaker Change: New therapy.
Speaker Change: Oh interest there.
Speaker Change: Just a quick comment and then I'll ask Susan to address in more detail.
Speaker Change: Nephrologist have been trying their entire careers with these patients to get their serum phosphorus levels in check.
Speaker Change: And they have been woefully unable to the single mechanism of action of binders irrespective of the type of partner than it is patients don't want to take that amount of material.
Speaker Change: Low phosphorous students are unpalatable, it's really a difficult life and when a new mechanism of action like this comes in it is Susan spoke in her opening statement about how this is being utilized along exactly what the votes were in our AD com is really heartening and I think physicians see the opportunity to finally have a tool.
Speaker Change: In their toolkit that may help their patients get into the target range that they've been trying to do and as Susan said also in our opening comments that we are hearing from patients and from physicians that these effects were sustained.
Speaker Change: That's heartening and extraordinarily rewarding that we're going to have that kind of impact on patients. It is early days.
Speaker Change: You always are going to have early adopters right, that's not an uncommon phenomenon.
Speaker Change: But the difference here is there is not one nephrologist out there that is not struggled with nor one patients out there that is not struggling with how to manage their serum phosphorus.
Susan: Susan anything to add.
Susan: Yeah, I would just say you know the spirit stated did report a 56% user base in that state of that that was generated in April so and what we're seeing in the field is that nephrologist really want to spend time with our sales team are getting in to these offices, they're learning about it and they do have patients in mind once a day.
Speaker Change: They are detailed unexposed to us so I think it's more around it's not around an early adopter profile as much as every doctor to Mike's point has been <unk> been managing this challenge of getting these phosphorus levels within target ranges with the limited options. They have and now are very open to.
Speaker Change: Incorporating exposed into the treatment regimen to try to do better. So I think that that's pretty common across all the nephrologist Barrett, it's going to be important to continue to move the uptake is to expand their thinking where it's not just that patient that they've always had in mind. It's been so challenging but now that you have a new tool you know as you see these spots versus every month.
Speaker Change: Don't wait for for a multiple reads are or try to make the you know everything work for them on diet or other things the things that they've struggled with now they should treat these patients because of the expanded treatment armamentarium. They have with exposure. So that's what's going to be important is just moving beyond that first cohort of patients that they clearly we're waiting for something.
Speaker Change: New and now you know adapting their practice to having a blocking mechanism drug like expose that.
Speaker Change: Thanks, guys that's really helpful.
Speaker Change: Yeah.
Speaker Change: 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.
Michael G. Raab: Thank you everyone for joining us this evening, including our investors who have been on this journey with us the employees, who drive our success, our partners, who support us and the patients that we serve.
Speaker Change: With that we can close the call. Thank you operator.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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