Ladies and gentlemen, thank you for standing by and welcome to the Tricida Second Quarter 2022 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during that time, please press star one on your telephone keypad. If you would like to withdraw your question, press star one. As a reminder, today's call is being recorded. I will now hand today's call over to Jackie Cossmon of Tricida. Please go ahead. Thank you, Tamika. Good afternoon, and thank you for joining the Tricida Second Quarter 2022 Financial Results and Business Update Conference Call. In today's call, Gerrit Klaerner, our Founder, CEO, and President, will provide an update on the ongoing VALOR-CKD renal outcomes trial and discuss our business progress. Jeff Parker, our COO and CFO, will discuss our financial results for the second quarter and review our financial guidance. Please note that in today's call, we will be making various statements that include forward-looking statements as defined under applicable securities laws. Forward-looking statements include our anticipated activities related to the VALOR-CKD renal outcomes clinical trial, including anticipated endpoint events accruals, and the estimated timing for receipt of top-line data, as well as our expectations regarding our financial runway. Management's assumptions, expectations, and opinions reflected in these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from any future results, performance, or achievements discussed in or implied by such forward-looking statements. Tricida can give no assurance that these statements will prove to be correct, and we do not intend and undertake no duty to update these statements. We also urge you to read the risks and uncertainties associated with our business that are described in our filings with the Securities and Exchange Commission. We issued our second quarter financial results press release this afternoon just after the close of market. For copies of our press release, please go to www.tricida.com and follow the link to our investor relations page. I would also like to note that we've posted an updated slide presentation on the investor relations portion of our website that includes updated information from our press release and call. At this time, I'll turn the call over to Gerrit. Thank you, Jackie. Thank you all for joining us today. As we reported in May, we've stopped the VALOR-CKD trial early for administrative reasons, as permitted by the existing study protocol to allow for six months of financial runway following the reporting of top-line results. We've continued to accrue primary endpoint events as clinical trial subjects complete their participation in the study. As of today, the 148 subjects who were randomized in the VALOR-CKD trial had an average treatment duration of approximately 26.5 months, and the trial had accrued 281 subjects with positively adjudicated primary endpoint events defined as renal death, end-stage renal disease, or ≥40% reduction in eGFR. Given the current event rate trend, we are increasing our estimate for positively adjudicated primary endpoint events in the final analysis. We now anticipate between 285 and 295 subjects with primary endpoint events in the final analysis, which is up from our prior estimate last quarter of 250-270 events. We anticipate that the last subjects will complete their participation in this trial in the third quarter, and we plan to report top-line results from VALOR-CKD in October 2022. We've reviewed various hazard ratios and corresponding powering assumptions for VALOR-CKD in prior calls. These calculations are also in our investor presentation on our website. To recap, assuming a true hazard ratio of 0.70, which corresponds to a 30% reduction in veverimer versus placebo endpoint events, if there are 250 events in the final analysis, the trial has 78% power. If there are 300 events in the final analysis, the trial has 85% power. Switching from power to observed hazard ratio statistics, the trial is expected to meet its primary endpoint with 250 events if the observed hazard ratio is 0.78 or lower, and with 300 events if the observed hazard ratio is 0.79 or lower. We believe that the VALOR-CKD trial will provide interpretable data to evaluate how treatment with veverimer impacts slowing of CKD progression in patients with metabolic acidosis and CKD. Before I turn the presentation over to Jeff, I'd like to say that we are really proud of our Tricida team, along with our partner CROs, who are doing a fabulous job ensuring an orderly completion of the VALOR-CKD trial at almost 200 sites in over 30 countries to enable top-line data in October. With that, Jeff will now provide an overview of our financial results for the quarter. Thanks, Gerrit. Our second quarter results were in line with our expectations with R&D expense of $16.9 million and $19.8 million for the three months ended June 30th, 2022 and 2021 respectively. The decrease in R&D expense was primarily due to a decrease in clinical development costs related to our VALOR-CKD trial following the administrative stop announced in May 2022. G&A expense was $9.8 million and $9.6 million for the three months ended June 30th, 2022 and 2021 respectively. The increase in G&A expense was primarily due to higher stock-based compensation expense. Net loss was $28.5 million and $33.6 million, and non-GAAP net loss was $21.3 million and $24.6 million for the three months ended June 30th, 2022 and 2021 respectively. As of June 30th, 2022, cash, cash equivalents, and investments were $98.7 million. We believe our current financial resources will fund our planned operations into early in the second quarter of 2023, which is approximately six months from the anticipated October announcement of top line results for VALOR-CKD. With that, I will turn the call over to the operator for questions. Operator. Thank you. At this time, if you'd like to ask a question, press star one on your telephone keypad. If you'd like to remove yourself from the queue, please press star one. Our first question comes from the line of Eva Privitera from Cowen. Hi. Congrats on the execution of the trial, and thank you for taking our questions. The event accrual seems to be happening faster than what was previously guided, which is great. What do you think is accounting for this faster rate? And is it still within the range of what you had previously modeled? Yes. Eva, thanks for the question. This is Gerrit. Yes, it's spot on. It's right in, I think, in the middle of what we expected, you know, over time. There was some uncertainty, you know, as we bring people in for the last visit in shorter intervals, if we would still see the same number of events that we've seen pretty consistently over the last year or year and a half of the trial. That's clearly the case. We continue to stay on track. Excellent. Thanks. Second question. You list the 0.76 hazard ratio, and that's, you know, based on the serum bicarbonate I've seen in the 301 trial and the Tangri model developed a few years back. There was a paper published last year by Tangri that draws from a larger database of patients. Is 0.76 still kind of the base case assumption, or can you point us to anything to point to possibly different hazard ratio? Yeah. I think we have a couple of different buckets here that we draw from, right? One you just described, and that was really important in the context of accelerated approval, where we obviously wanted to connect the serum bicarb effect and then ultimately the expected outcome benefit. Now, the other bucket are really sort of some of the smaller academic trials, the de Brito study, Garneata, where interventions like oral alkali or extreme low-protein diets in patients who could tolerate these interventions were studied in single-center trials. There we had hazard ratios that were much, much lower. That's also in our slide deck, investor slide deck. There, basically you're looking at hazard ratios in the 0.25-0.5 range. Then of course, we had our own study where we had a pre-specified safety analysis that is quite different from the renal endpoint, but had all-cause mortality and dialysis and 50% eGFR decline in the TRCA-301, 301E study. There we saw basically also a fairly significant and small hazard ratio of, I think it was a 65% reduction in those DD50 events. Again, not a renal endpoint and very, very small numbers. The way we think about it, we look at all three, and I think that gives us comfort that we ultimately, when we take a look, that we are below the 0.78 or 0.79 in terms of hazard ratio. That's very helpful. Thank you. Your next question is from the line of Serge Belanger from Needham. Hey, good afternoon. Just a couple from me. I guess first, just looking forward to October and thinking of the data readouts. Are we just going to see the top line, the primary endpoint, or should we also see some of the secondary endpoints at that time? Thinking of those secondary endpoints, which ones are the most important for the what you project the label to be for veverimer? Given the stoppage of the VALOR trial, just curious whether you think the study is powered well enough to see a stat sig difference on some of these secondary endpoints. Thank you. Serge, thanks for the question. Yeah. We, again, we are right now, sort of we're busy really taking down obviously the trial in an orderly manner and then, ultimately locking the database, analyzing the data, and then obviously sort of communicating, as soon as possible. The primary endpoint is really it, right? Let's be very clear in terms of FDA approval, in terms of the claim for slowing of CKD progression, we are really laser-focused on the DD40 endpoint. Now, we do have other endpoints that describe the slowing of CKD progression. There's obviously the DD50. There are the individual components. There's eGFR slope, and they are. I think they're all important. The idea is hopefully that, you know, if we are successful on the primary, there's a good chance we also can see some interesting things on the individual components and some of the other renal-related endpoints. To me personally at least, those are that's really from a labeling perspective, from an FDA discussion perspective, that this is really where the rubber hits the road. Now, we do have endpoints on physical functioning, and obviously that's really very important for patients. I think we are of course interested in the KDQOL, which is the patient-reported outcome and also the repeated chair stand test. I think it's less clear. Those are not basically the same in terms of proven endpoints from a regulatory perspective, but they're obviously really very important for patients and how a patient feels and functions. Those are really the two buckets that we are focused on and that are important to us. Others around mortality and hospitalizations, you know, to be clear, those are all, I think, important endpoints. We did run this against the backdrop of a 100-year pandemic, right? I think that's always a question in terms of what type of noise is generated in terms of hospitalizations and overall mortality. We're paying a lot less attention at least at this stage to some of those other endpoints. Thank you. Look forward to seeing the data. Thank you. Over to you. Your next question is from the line of Jessica Fye with JP Morgan. Hey, guys. Good afternoon. Thanks for taking my question. Maybe asking the first question a little bit of a different way. How much separation between arms on serum bicarb do you think is needed to have an impact large enough to achieve a hazard ratio no higher than 0.79? I'd try to answer that if we were still pursuing accelerated approval. To me, basically, you know, we expect, you know, obviously, you know, a statistically significant difference in serum bicarb between active and placebo patients. I think this overly quantitative view, as I said before, was very important, you know, to get initial approval on the basis of the surrogate, which we didn't. You know, I think that to us, I think it's much more important to have a larger number of events that we are observing right now so that, you know, if we were sitting here just with 200 events or so or 230 events, that would make me, I think, a little bit more nervous than sort of an expected serum bicarb difference because the fewer events you have, the more random variability plays into this. With us having 281 events as of today, I think that really gives us a chance to truly see the effect. I think we stopped right around the time of the CRL or the ADL. We stopped kind of having this very quantitative view of serum bicarb in outcomes. Got it. Just so I better understand, when in the third quarter might you finally stop counting events? It seems like every update we get, the projected number of events goes a little bit higher, and so I wanna make sure I'm thinking about that potentially happening one more time. No, that won't happen because this is the last call before data. Okay. Thank you. Our final question comes from the line of Madhu Kumar with Goldman Sachs. Hey, guys, this is Rob on from Madhu. Thanks for taking our question. So I was just wondering what information will be disclosed in the VALOR-CKD top line data. Then beyond the top line data, are there any other gating factors for an NDA submission? Rob, yeah, as I said, you know, we basically sort of obviously are going to disclose the primary endpoint, you know, and depending on, you know, how many we get to analyze, you know, the secondary endpoints as well. Ultimately, I think the important piece here is also the primary endpoint individual components, you know? To me, everything else is, I think, interesting but not critical, right? Of course safety. I mean, I think, you know, this is a multiyear study and in a large group of patients, and so we'll have obviously safety data. As you know, ultimately what this comes down to from an approval perspective is risk-benefit. I think at top-line, our goal is to give a clear picture of safety and efficacy so that I think this will ultimately then inform the risk-benefit that is underlying the approval decision. As you know, we are very data-driven, and we move very quickly, so we will basically include as much as we can at this time point of communicating top-line data. Thanks. At this time, there are no questions. I will hand the call back over to the presenters for any closing remarks. Thank you all for joining us today. As always, if you have additional questions, don't hesitate to email us at ir@tricida.com. Thank you and goodbye. This concludes today's call. Thank you for joining. You may now disconnect your lines.