... Good morning, and thank you for joining us here today at the Wells Fargo Healthcare Conference. I'm joined with the team from Akebia today. Today, we have Erik Ostrowski, who is the Chief Financial Officer at Akebia, as well as Nick Grund, who is the Chief Commercialization Officer. And so today, we're going to present sort of a dual hybrid presentation and fireside chat. And so to start off, we'll go with some slides from Erik.
Great. Thank you, Patrick, and thank you to Wells for inviting us here today. Before we jump in, just a reminder, we'll be making forward-looking statements and refer you to our SEC filings for more details on the company, so really excited to be here today to tell you about Akebia Therapeutics. We are a leading commercial-stage company focused on kidney disease. We have two commercial products. One is Auryxia, which is a phosphate binder. It's been on the market for several years and lost IP exclusivity in March of this year, yet generated $47 million in revenues in Q2, so it's been really a great product for us today, so we're going to focus more on Vafseo, which is our new product we launched in January. It's a treatment for anemia due to chronic kidney disease for adult patients on dialysis.
This is a billion-dollar market opportunity in the U.S. We're also pursuing label expansion for Vafseo into the late-stage non-dialysis CKD population. We believe this is a multi-billion-dollar market opportunity, and we'll talk a bit about our Phase III plans there. Vafseo is built off of our Nobel Prize-winning hypoxia-inducible factor technology. We utilize this technology across a number of our programs in our pipeline as well. Importantly, we are in a solid financial position. We ended the second quarter with $137 million in cash and believe we are financed to profitability. We firmly believe that Vafseo can become the new standard of care for the treatment of anemia due to CKD. This slide outlines key elements of our clinical value proposition, which really starts with our unique mechanism of action that stimulates the body's natural response to hypoxia.
This is in contrast to today's standard of care, ESAs, which give the patient a large amount of protein. What we are stimulating is a more physiological response that enhances the body's natural production of EPO, activates iron mobilization, controls hemoglobin levels within a desired range over time, provides for simple titration, fewer dose modifications, and importantly, comes in a convenient oral dose form. So as mentioned, this is a billion-dollar market opportunity in the U.S. There are about five hundred thousand patients in the U.S. with anemia caused by CKD. We are looking to address that full patient population, but what we highlight on this slide is that there are particular segments of this population that are very much underserved by ESAs, the current standard of care. One group is the home use or home dialysis group.
There's about eighty thousand patients in this segment, and, as you might imagine, having an oral dose form to offer these patients as compared to injectable ESAs is viewed as quite advantageous. The other patient segment we highlight is the higher ESA dose patient segment. As the name implies, these are patients who are on higher-than-typical levels of ESA, and we know as ESA levels increase, so do safety risks, and so again, have a compelling value proposition for that segment as well. So here is an abbreviated chronology of key steps leading up to the launch of Vafseo in January of this year. We obtained FDA approval in March of 2024. Notably, in October of 2024, we obtained a Transitional Drug Add-on Payment Adjustment, also referred to as TDAPA.
TDAPA is a mechanism put in place by CMS that provides dialysis organizations incremental payment for two years for adopting new innovative technologies such as Vafseo. We announced in January of 2025 that we had secured contracts covering nearly 100% of U.S. dialysis patients. So we are contracting directly with the dialysis organizations, and this was really a key step for us ahead of the launch to really set ourselves up for a strong start out of the gate. This culminated in revenues for Q2 for Vafseo of $13.3 million, and again, we're really happy with how this launch has started. So now I'll drill in a little bit on some of the key commercial metrics that we look at, as well as talk about some catalysts to continue to drive growth of Vafseo revenues.
So when we talk about utilization of Vafseo, we often talk about continuing to expand the breadth and the depth of, of the product. What we mean by breadth is number of prescribers, and by depth, we mean number of prescriptions that those prescribers are writing. We saw both of those metrics increase from Q1 to Q2. In terms of prescribers, we had 640 prescribers in Q1, increased to 725 in the second quarter. And in Q1, on average, prescribers writing 12 prescriptions each, that number increased to over 13 in the second quarter. In terms of getting to that next leg of revenue growth for the product, we think it's really important that we continue to expand prescribing access to Vafseo. And what do we mean by prescribing access?
I mentioned earlier that we have contracts in place with the dialysis organizations, and that clearly is the key initial step. After that, the DOs need to put protocols in place within their organizations, and then those protocols need to be operationalized. It's at that point that we deem patients as having prescribing access. We had about 40,000 patients with prescribing access as of the end of Q2. We expect that number to increase multifold to 275,000 patients by the end of the year. Related to effort, really, excited to announce today that as of mid-August, DaVita has initiated their operational pilot of Vafseo across more than 100 of their dialysis clinics. We look forward to DaVita opening up access to their 200,000 patients post-pilot.
In order to become the standard of care, we think it's really important that you continue to generate data that highlights the benefits of your therapy. And so I wanted to take a couple of minutes to talk about our VOICE study. This is a collaborative clinical trial we are conducting with U.S. Renal Care. U.S. Renal has really been just a great partner of ours. This trial fully enrolled in June of this year, about 2,100 patients. We expect top-line data in early 2027, 18 months past randomization of the last patient. From a study design standpoint, we have two treatment groups. We have the Vafseo group, and then we have a group treated with the standard of care, ESA, and we're looking at all-cause mortality and all-cause hospitalization.
Of note, this study is powered to evaluate superiority for all-cause hospitalization if it can demonstrate about a 10% decrease in hospitalizations with Vafseo. Why is that important? When patients on dialysis need to be hospitalized, the DOs share in a portion of those costs for the hospitalization. So if we can show that the Vafseo group, those hospitalization rates are going down, that's great, first and foremost, for the patients, but also for the dialysis organizations who will save in that incremental expense. So we look forward to sharing data from this trial in due course. Now we will shift to the non-dialysis opportunity. As mentioned, we believe this is a multibillion-dollar opportunity.
There's about the same number of patients with anemia caused by CKD in the U.S., about 550,000 , as there are patients with anemia caused by CKD who are on dialysis. The big difference here, though, is with respect to the payer dynamics. In the non-dialysis segment, you're looking at predominantly private and unbundled government payment, and so we therefore would expect to see higher pricing in this segment. And in the Q&A portion today, Nick will have the opportunity to talk to you some more about the high level of unmet need that we see in this NDD segment of the market. So what are our plans? We are looking to start a phase III trial, which we call VALOR. This will be a cardiovascular outcome study, about 1,500 patients in the U.S. with Stage four or five CKD, not on dialysis.
We are engaging with FDA on this study. We have had a Type D meeting. We have requested a Type C meeting, and following FDA feedback, we plan to finalize the protocol, and we plan to start this trial by the end of this year. I'll now talk a little bit about our pipeline beyond NDD. We have a number of programs, many of which utilize our HIF-based technology. I'll highlight a couple here. One is AKB-9090. This is a program in AKI or acute kidney injury. Large unmet need. We are progressing this trial into a phase I this year. Another program we are really passionate about is AKB-10108. This is an ROP or retinopathy of prematurity. This is a rare disease.
It's outside of renal, but notably a disease in which we think our HIF technology matches up nicely against the biology of this disease, and we really hope that we can make a positive impact for patients here, and likewise, look forward to continuing to progress this trial into the clinic, so collectively, you're looking at multiple billions of dollars of incremental market opportunity for the company across this pipeline. 2025 has really been a transformational year for Akebia. As we look at our objectives for the rest of the year, first and foremost, we'll continue to execute on the U.S. launch of Vafseo. Secondly, we plan to initiate the Vafseo phase III trial in that non-dialysis segment by the end of the year. We have, ahead of schedule, achieved our objective of fully enrolling the VOICE trial.
And lastly, and importantly, we will continue to advance our pipeline beyond NDD, including our work with AKB-9090, which is our program in acute kidney injury. So with that, I'll turn it back over to Patrick for some Q&A.
Sure. Thank you, Erik. Thanks for providing the overview on Akebia. That's fantastic. Would love to go, you know, a little bit more into some of the detail around both Vafseo and the opportunity that's there. So I've put together a couple of questions in order to facilitate some of that discussion for the next 20 minutes or so. Nick, could you possibly start by providing, you know, a little bit more detail around the opportunity that exists in treating the anemia of patients that have anemia associated with dialysis? And so what does that group look like? Is it a homogeneous group, sort of? Is it expected and projected to grow over the next couple of years? And sort of what is the forecast and opportunity that's there?
Yeah, when you think about the overall dialysis market in itself and those patients that have anemia, it's around 550,000 patients in it. Over the last number of years, it's been a fairly stable market. Prior to COVID, it was actually growing kind of at 2%-4%. COVID, unfortunately, has stunted the growth of the market a little bit. It seemingly is recovering more recently, but generally about 550,000 patients. As Erik alluded to, all those dialysis patients, you have really three segments of the market. There are the folks that are in the home population, and that's about 80,000 patients. You have the patients that are not well managed on an ESA. What that means is-
... they're either receiving higher doses of ESAs because their response rate is not very well, or they're continuing to fluctuate in their ESA dose. In other words, they're coming in for consistent dose modifications. That kind of hemoglobin cycling, that high-dose ESA, has been associated with increased cardiovascular risk, and so that population is very important, as well. And then our label is very broad. You've got the general population that is under the care of an ESA but is also a population that Vafseo can address as well.
And so just to hone in on that a little bit, I think about patients that are having a difficult, you know, ability maintaining hemoglobin, and sometimes they, you know, go beyond where they need to, and it becomes a safety issue. Could you maybe highlight a little bit about the safety profile, about Vafseo that is interesting and helpful in this situation?
Yeah. So when you look at Vafseo, you know, when you, when you're using ESA, you're usually using a synthetic hormone, you're really dumping it in at the end of the chain. Where Vafseo is working earlier, and using the body's and trying to help the body naturally stimulate erythropoietin. And so what we see is instead of a large bolus of ESA going in and then over time declining, Vafseo from an EPO effect actually has very minor but consistent increases in EPO levels that leads to a more consistent treatment paradigm. And we believe that more consistent treatment paradigm will lead to better outcomes. Obviously, the VOICE trial is out there trying to prove that.
Sure.
In addition, you're getting ancillary benefits, iron mobilization. You know, and in order to make a healthy red blood cell and oxygen, you kinda need two things: erythropoietin and iron.
Mm-hmm.
And so, you know, having iron mobilization is a very interesting way to be able to get, you know, a dual mechanism action around how do you treat these patients appropriately.
That's great. And, you know, congratulations on the progress that you guys have had. You're two full quarters into the launch so far. Would love to get some perspectives on the progress that you guys have made, and sort of what has been the response that you have seen from prescribers and from docs that are in the space?
Yeah. We've been overwhelmingly happy with the advocacy, the interest from physicians. Let's be honest, they've been waiting for a HIF- PHI for quite some time. And so it's really great that we've been welcomed with open arms. You know, we do peer-to-peer engagement programs, and record attendance at those.
Mm-hmm
... which has been great by both physicians and clinic staff. When we think about how that translates into, we'll call it, the results, Erik alluded to the 725 physicians, the on average thirty prescriptions. You know, right now, our primary customer is USRC. The other organizations are going through the protocoling process, which we'll talk about, I imagine, in a little bit. But from a USRC perspective, over 80% of their physicians have written a prescription for Vafseo. Over 80% of their clinic have prescribed Vafseo.
Mm.
And so when you think of demand growth of 55%, Q2 versus Q1, it's really that core physician base expanding and going deeper. The other thing we're very happy to see is dose. You know, dose, yet making sure patients are on the right dose is so important to controlling any disease state, anemia in particular. And so when we think about dose, it's been increasing. They've been titrating up from the starting dose of 300 mg. We've seen about a 25%-30% increase in dose as patients continue to get refills, and that dose level is approximating what we saw in the INNO2VATE trial study, which is one of our pivotal clinical studies that led to approval.
Sometimes when you put in a product into clinical practice, the actual results don't actually match up with your study. It's good to actually see that we're seeing what we saw there and good for patients. They're getting to the right dose, their anemia is controlled, and frankly, 25% more dose means it's 25% more revenue.
Yeah. I mean, I can't imagine the inertia that continues to exist with nephrologists that have treated dialysis patients for a long time in order to get them to convert over to writing and getting comfortable and prescribing a new drug. It's a lot of legwork, and so congrats on that. Yeah. I know you mentioned a little bit earlier, like, this growth from 40,000 up to 275,000 potential prescribers, by the end of this year. Would love to get just a little bit more granular around sort of how that is progressing, like, what the steps are, sort of what that looks like, and you know, how you guys see it moving forward.
Yeah. So when you think about the dialysis market, it is, you know, a majority of it, of the dialysis population sits in, we'll call it, the top five dialysis organizations. You know, there's Fresenius and DaVita that both have over 200,000 patients. They're the big, the larger LDOs, as we call them. And then you have a group of mid-sized dialysis organizations that includes U.S. Renal Care at about 36,000 patients. IRC and DCI both have about 16,000 patients. When we think about where we were in the first half of the year, USRC was the vast majority of our sales. They protocolized quickly. We are thankful for their partnership. They are advocates for the product.
And so when you think about that 40,000, it was USRC and a bunch of IDOs, SDOs, I call them dogs and cats, but a lot of smaller ones in there. Maybe they have 1,000 patients, 250 patients, 400 patients, and that made up the 40,000. While we think there's still growth opportunity in that segment, when we look to transition further, it's really going deeper into that. And so we look at what's happening in Q3. We announced a week ago that IRC, at 16,000, has protocolized the product, and it's available for prescribing.
Mm-hmm.
So prescribing access has been achieved. We expect DCI to come on here in the third quarter as well, and so that's really the number four and five will be protocolized, prescribing access achieved, in quarter three. More importantly, the DaVita pilot, right? So DaVita being 200,000 , 204,000 patients.
Big name.
Big name, right?
Yeah.
And they've initiated what they call an operational pilot over a hundred clinics. It's not to check safety and efficacy, it's really to make sure all the systems talk to each other. When you're that complex with thousands of clinics, you wanna make sure everything works right. And so, you know, their over a hundred-clinic pilot would make them just about the fifth-largest dialysis organization. The pilot alone.
Wow!
And so it's massive, and really important for us to get right. And so we're partnering with them well. That kicked off kind of middle of August. Folks are initiating patients on therapy. We're really pleased with where the DaVita pilot is going. Now, that's the pilot's gonna last about three months.
Yeah.
And when successful, they'll open that product up and allow all of their physicians for their 204,000 patients to prescribe. And that's really the goal, that you add all those numbers together, and you get to this 275,000 patients available by year-end.
Got it. No, that's impressive, and it came up a couple of times, and I think we should probably talk about it just a little bit, but what is the process of moving a drug into a new dialysis organization? So from contract to protocol to actual prescriptions, like, what does that look like, and how I can't imagine how detailed it is, but I bet there's a lot of different steps to it.
Yeah, you know, dialysis is always fairly unique, right? And so when I think about it, you have to have a product that has clinical value. But you also have to have an economic value, and patients have to be reimbursed. And so how do you get that economic value with dialysis organizations? Well, you need to contract with them to make sure that they're being reimbursed appropriately for the products versus what they're paying for it. And so, really proud that prior to launch, we had 100% of patients at dialysis organizations having access to contracts.
Hmm.
And representing a favorable economic value proposition. Then you go into the clinical world, where you're working with the clinical side of the dialysis organizations around educating them about the product, the published data, the label, where they can use it. And with that education, they say, "Huh, we wanna use it here or in this patient population." So they write a protocol. The last step of that is they actually have to put the protocol into the system. They have to train their staff. They have to make sure all the systems talk to each other, and so we call that operationalizing the protocol.
And so those are the three steps, and once it's operationalized, then our teams are able to go in there and work with physicians, further educate them, help them identify patients, and then we're off and running.
Are you working hand-in-hand with them to establish those protocols and the setup, or is it largely internalized inside of the dialysis organization?
Yeah. Our medical team has done a wonderful job educating.
Yeah.
It's really around us educating on the breadth of science because as you're probably aware, your label is just a small piece of the data that you've accumulated for the product over time. And so helping them put that in context, helping educate them on the breadth of the data, and then they're really making the decisions around it. As they go through the initiation, they may wanna make tweaks to their protocol-
Mm-hmm.
And we're actively helping educate on whether those tweaks are good, bad, indifferent. And so it's a partnership, but they're responsible for ultimately writing the protocol.
That's right. You know, I think one of the things that I was coming up to speed when, before we met last year, was around the importance of TDAPA and sort of what that means as far as, like, reimbursement in the first two years of the launch. And so for the group that's here and has joined us online, I think it would be great to get, you know, pretty detailed around sort of what that means and what that looks like.
Yeah, you know, CMS really looked at this space and said, "You know, hey, if we go to a bundled payment for each dialysis session, you're likely to squash innovation." They created TDAPA, the Transitional Drug Add-on Payment Adjustment. What that is, is an additional payment outside of the bundled rate, in addition to the bundled rate for innovative therapies. It lasts typically two years long, and products have to qualify for it. So you have to submit, qualify, and be granted TDAPA status, if you will, and then Vafseo has done that. This additional payment is utilized to incentivize dialysis organizations to try innovative therapy.
Hmm.
And that's the thing. If you look at ESAs, they're in the bundled rate.
Sure.
They're in the bundled rate at about $15 of the $274 per treatment. That's ESA-related. When you utilize a TDAPA product, you no longer incur the $15 cost associated with ESA. You still get the $274.
Okay.
You no longer incur the $15 cost, and you get an additional payment for Vafseo. So there's a cost avoidance and an economic profitability component associated with the purchase of Vafseo.
Got it.
Those things, two things together allow them to try these innovative therapies.
And so the TDAPA program lasts for two years, and then post-expiration, what does the world look like after that?
Yeah. We've talked often. I mean, we worked with dialysis organizations prior to launch, and really, going out there is we wanna make sure patients can continue on therapy with Vafseo. Some of the prior products who have launched in the space really didn't have an answer for what happens post-TDAPA. Our answer is: We're gonna match the ESA pricing.
Yeah.
And so we're gonna be very similar to the ESAs that are on the market today, therefore, making sure that there's not a financial disincentive for dialysis organizations and for physicians. Physicians hate putting a patient on therapy and then having to take them off the therapy they're doing well on and put them back on something that they might not do well on.
Right.
And so they don't wanna have that cycling of patients in and out of therapy. We think we've got a solution to that with the matching of the ESA pricing.
Yeah. Right.
That pricing transparency, you know, we think is really important to becoming standard of care.
Yeah.
You know, we talked about other key elements. You know, it all starts with the clinical value proposition, but that price transparency, the continuation of data generation, we talked about VOICE as well. If you have these three elements, again, we really think you're in a good spot to become the standard of care.
I think that's a great position to transfer into, to VOICE, just to understand what that program, you know, what it looks like, what it can mean for the organization, and sort of the timelines around when you guys are expecting to have some data that comes from that side?
Yeah, maybe I'll start and maybe kick it to Erik if he's got additional comments, you know, when you think about a patient population, the voice study is really two things: using the products three times a week in the clinic.
Mm-hmm.
And so you eliminate some compliance challenges, et cetera, et cetera. That patient is well-controlled in a TIW setting. And so it's off-label, but having a proof out there and data out there that you can use it is important for physicians to understand. Secondly, hospitalization and mortality. When you think about the costs that Erik alluded to in this hospitalization rate, on average, a dialysis patient is hospitalized twice a year. On average, each of those hospitalizations costs about $60,000 a year. So there's about $120,000 of cost in that system that the DOs are on the hook for a portion of it. So if you can eliminate that by 10% per patient, that's a $12,000 cost savings per patient. Massive.
Importantly, when the patient's in the hospital, they're not in the chair, so you're not collecting your $274, right? And so that $274 is a meaningful piece if they're out of the chair for a significant portion of time.
They're getting dialyzed at the hospital.
They're being dialyzed-
Yeah, yeah
... at the hospital.
Yeah.
Or, God forbid, foregoing dialysis.
Right.
And so the economic benefit for dialysis organization is, I don't want to say obvious, but a big number.
Yeah.
Patients do better when they're not in the hospital, right? And so being able to keep patients out of the hospital, hopefully being able to demonstrate a mortality impact, we're in the business of working with dialysis and CKD patients to benefit them and improve their lives.
Mm-hmm.
You don't do that without being able to show a positive outcome, in mortality or hospitalization, and so this is a cornerstone of kind of how we think about building the evidence generation for that dialysis population.
That's great. That's great. Erik?
Yeah, I'd just add, you know, maybe it's intuitive, but, you know, that NDD label expansion would provide great synergies from a financial infrastructure perspective, right? Salesforce synergies, manufacturing synergies, general infrastructure synergies. So a really nice add-on to what the product portfolio stands today.
Yeah. No, that's interesting. And so, like, thinking about non-dialysis patients, like, how early could Vafseo be used? Like, is it patients that are truly, like, stage five end-stage renal disease, or could you drop back to stage four, stage three, depending on where their GFR is? Like, what, what is applicable here? And sort of like, when I think of the world around, like, non-dialysis patients and anemia, like, you've got oral iron, IV iron, you've got ESAs, and then you're adding this on, where could this potentially fall in that, you know, range of treatments that would be available?
Yeah, it's a great question. I mean, patients start being anemic in kind of around stage three, right? Now, they increase the percentage of those populations that are anemic from three to four to five. As patients progress, the percentage of those populations that become anemic grows, but there's applicability in all three of those stages. The thing about that market is, yeah, ESAs are available, but they've been declining in use. Just under 30% of patients today who have anemia in non-dialysis are being treated with an ESA. That's a decrease from nearly where it was 50% of patients being treated a number of years ago, it's down to 28%. The question is, why? They're not any less anemic.
Yeah.
And so when you look at the why is ESAs are really a rescue therapy. When you think about how insurance companies and how physicians are using them is they're not allowed to use an ESA until their hemoglobin drops below ten.
Okay.
And so you have a patient that comes in, they're anemic, they get a shot of an ESA, it goes up, it starts to come down. They can't actually treat proactively until it goes below 10. Then they treat again, and you get this hemoglobin cycling that we talked about.
Constantly chasing your tail. Yeah.
Physicians are really worried about, are they? What's the risk-benefit there? Are they doing more harm than good, if you will? So they wait, or they don't use them, and they use it as a rescue therapy. You see transfusions in that population going up, and if you get a transfusion, you reduce your eligibility for a kidney transplant.
Hmm.
That's a massive patient concern.
Yeah.
If you're now moved down the list or you have to wait, imagine every time you get a transfusion, you can't receive a transplant for 90 days. If the call comes, and there's a match, and you're in that ineligible period, you have to forgo it, and hopefully, another one will come up. Massive issue from a patient satisfaction, patient progression standpoint. We view an oral therapy, Vafseo, being able to kind of smooth out that hemoglobin cycling, instead of being a rescue therapy, being a maintenance therapy. Folks being well-controlled over periods of time and not taking them off transplant list, not increasing the cardiovascular risk associated with those patients.
No, that's a really interesting point to consider, especially around becoming ineligible for a transplant. That is not something that I had considered.
Yeah
... in the past. Just to shift back a little bit around to the launch, has there been anything in the commercial launch that has surprised you?
You know, what's interesting is, you know, I've been doing this for way too long, probably. But when you think about a launch, this one was particularly interesting, is binders, phosphate binders, were also going in the bundle at the same time.
Yeah.
While we knew there would be disruption from that, we didn't recognize how much disruption. You know, the larger dialysis organizations kind of had it on rails. They can work their way through it. Their disruptions were relatively minimal, but the medium-sized to smaller folks, it took them longer. It's a bigger cost item that was shifting for them, and so they had to take care of binders first.
Yeah.
And so that took them some time. I think that resulted in us shifting where we're gonna get more access to patients later in the year.
Yeah.
And so that maybe is the surprise of maybe looking at that disruption and thinking it was gonna be more manageable.
And maybe that's a good point to segue into Auryxia, your other product that's been out there that lost exclusivity earlier this year. You know, how has that product continued to fare? Do you see any potential competition that's coming up on the horizon? Any insight into that?
... Yeah, Auryxia is interesting. It's been on the market just about eleven years. Okay. It's a well-understood clinical profile. Physicians really want to use Auryxia for all of its benefits around controlling phosphorus. It's always been plagued with a lower access profile than most. In some ways, our contracting strategy has increased the number of addressable patients.
Mm-hmm.
And so what we see is, we'll call it a resurgence of Auryxia, which has been really good from a P&L perspective, cash flow perspective, patient perspective. But we also know that it might be a little short-lived here. I don't know, Erik, if you want to add commentary onto that one.
Yeah, no, I mean, you know, I would reiterate, yeah, we're obviously really pleased, right? I mean, Auryxia has shown, since losing IP exclusivity, quarterly year-over-year increase, sequential quarterly increase in revenues. There's an authorized generic, but obviously, you know, no incremental generic competition yet. So, you know, we budget conservatively for Auryxia, and, you know, the longer we go without incremental generic, you know, competition is really just more upside to our internal, you know, forecast.
No, that's. It's good insight, and it's good to see the product has hung in there, as well as it has over the last couple of quarters. Fantastic. And then maybe just to close out. I know you guys raised some cash earlier this year. You're starting to generate revenue. What is sort of the financial projections and, you know, the position of the company as it stands now?
Yeah, you know, really happy with our financial position. Ended the second quarter with $137 million in cash. As mentioned, you know, we are financed to profitability, and when we look at that guidance, you know, we take into account, obviously, revenues coming in from the products, but we also take into account the expense side-
Sure.
you know, including the cost of the planned NDD trial.
No, that's great. And I really appreciate the opportunity to meet with you guys here today. I don't know if there's any closing statements that you want to provide, but if not, it's been great to have you here at the conference and to participate in our Fireside Chat again this year. That's really good.
Yeah, no, thank you very much. It was great to be here.
Awesome. Yeah. Thanks, guys. Thank you very much.