Then we'll get set with our next presentation here, Fireside Chat of Aurinia Pharmaceuticals. Today with me is Peter Greenleaf, the President and CEO. I'm Doug Miehm, I cover the company for RBC, and have for a number of years. I thought maybe for setting the stage here, Peter, what we could do is can you talk about the data that's been generated recently, including biopsy data and those sorts of things, and how it's going to figure in the messaging in terms of the company? Sure. Well, thanks for having us here, Doug, and good to see you. There've been a couple data sets that we most recently reported on over the last, let's call it, 12-18 months. The first being the extension study to the original AURORA pivotal study, which was one year of data that we filed on with the FDA. We extended that an additional two years, so three total years of data. That data was actually published, and now can be used much more significantly now that it's in the public domain and published. In addition to that, we did a sub-study of the AURORA analysis, where we looked at a subgroup of patients over an 18-month period, where we did serial biopsies on those patients. Mm. Both obviously, and in addition to that, we submitted all of those data sets to the US FDA, and got an updated label, which we most recently reported out on. I think collectively, all that data is important for our prescribers to see in terms of both the continued efficacy of the drug, so it works. It not only does it rapidly, but it sustains, a proteinuria reduction response all the way out to, three years, and it does it in a setting where you're not, giving anything up in terms of the risk profile. Right. Obviously, our drug is a next generation calcineurin inhibitor, and they've had a history of using things like tacrolimus and cyclosporine. And there's not a lot of long-standing data in lupus nephritis for either of those drugs or even the novel drugs that have been out there. So, in terms of whether it's the efficacy side of the equation or it's just the continued reinforcing of the positive safety profile of the product, both are extremely meaningful to docs. The impact side of it that you're asking, I think we've seen it in a couple different ways. One, in terms of just attitude and awareness work that we do with physicians, the comfort is probably at an all-time high in terms of our product and their perception of. And second, the prescribing. I, You know, we continue to see new patients being put on drug, yes, but in addition to that, patients being kept on the drug for longer periods of time. Most evidenced by this last quarter, when we reported where we saw a pretty meaningful improvements at 12 and 18 months persistency on the product, going up a couple percentage points on both. So it'll take time, but, the data's obviously been meaningful, and it's completely threaded into, our message and what we try to promote out there. Okay, perfect. Now, when you think about the guidelines that are available now, EULAR, ASN, how are doctors actually prescribing and treating relative to how you think they should be? Well, what's interesting is, the new guidelines provide updates in terms of some of the goals of therapy, but more importantly, they incorporate novel therapies into the approach. But there's been consistency, even in the old versions of guidelines, awareness of, around target areas for treatment, diagnosis, how aggressively, physicians should be working to hit certain targets in terms of proteinuria reduction, and the impact of doing so. What we've found is there's a pretty significant disconnect between, diagnosis rates, so on every visit, and all the guidelines are fairly consistent. Every visit a lupus patient has, we're not even at nephritis yet, but a lupus patient visiting a rheumatologist should be getting a 24-hour urine screen. Mm. We know from other data sources that, you know, less than 50% of these patients even get a diagnosis. So and our belief, and from the data we have internally, is that there's a significant under-diagnosing that's happening in the marketplace today, where patients have the issue, and it's not being recognized. So a lot of our campaigns center around that. The guidelines are very, very consistent. Every time a lupus patient comes to the office, they should be doing a proteinuria screen. It's a huge area of lupus. It's progression. When it becomes nephritis, obviously, there's a material impact to how the patient will actually progress from a negative standpoint. So under-diagnosis, a big issue and opportunity as it relates to guidelines. The second is treating to target. What we're finding in the actual treatment of the disease, from pulling ICD-10 codes to what we know just in our own data we have on the utilization of our drug and MMF, is that there's a greater preponderance of physicians who will actually treat the disease when a patient has or shows one gram or more of proteinuria. But when a patient actually is diagnosed, and they have below one gram, they're more often not treating that disease. They're even coding it differently in some cases, where they'll code it as lupus with kidney involvement and not actually code it as lupus nephritis. Well, your question about the guidelines, the guidelines are crystal clear about three things: diagnose on every visit; once a patient is above a certain level, and it's in that range of 0.5-0.7, that they need to get them down below those rates. What we know, they're not diagnosing much, and when they're at those levels, physicians aren't aggressively treating. They're waiting till the patient is sicker. The last piece, and this is true about MMF, steroids, our drug, now other novel drugs like Benlysta, is they're not keeping patients on drug for long periods of time. All of those guidelines say a patient should stay on drug for between three and five years of therapy, to keep proteinuria in check. What we know is that most physicians opt for, in the conversation with the patient, putting them on drug, getting their proteinuria under control, and then taking them off drugs Yeah only to, when they re-flare, put them back on drug again. So all of these represent a change in physician treatment behavior that we actually have to evolve before you even get into the consideration of what drug are you gonna treat with. Right. Let's expand on that. I know that you've recognized it as a significant issue as it relates to the urine test. Have you been documenting how you've been able to improve those types of numbers as it relates to the tests as a starting point? Yeah, well, if you look at just the awareness studies that we do with rheumatologists, and because that's the primary- Yeah where the initial diagnosis is gonna happen. They're telling us that they recognize it, and they need to do more of it. Have we seen it actually translate Yeah into the coding? And so far, not yet. The intent is there, but the actualization is not there yet, and we just have to continue to work on that. You know, our drug, when you're trying to actually achieve the goals of what these guidelines lay out, is the only drug that's been proven to not only lower proteinuria levels by greater than 50% out to a year, but meaningful improvement to hit the guideline criteria at six months, at as early as one month. That's much better than the current standard of care. So we have to just continue to work with physicians and educate them on the available data that's out there. So the momentum is there. We actually have to start seeing it materialize into how they're treating. Yeah. Well, the data are, you know, they're very, very strong. So one item that you mentioned a couple months ago, and I just found it very surprising, is that even when they identify a patient with too much protein, they're only treated 30% of the time. How does that make any sense? Well, I think it's somewhat of a qualitative answer to it, but remember, rheumatologists on average see about 50 patients a day in the US. The majority of those patients are not coming in with proteinuria involvement. They're coming in with other arthropathies, joint pains, rheumatoid arthritis, et cetera. They're more actively looking at physical signs and symptoms and how the patient is reporting out. If a lupus patient comes in Mm-hmm they're more often gonna be complaining of fatigue, of joint pain, of skin involvement, et cetera. If they're not taking a urine screen, they surely don't know what's happening to the underlying kidney because it's not an outward, there are no outward signs and symptoms of active proteinuria. And when a patient actually does have, and this is the qualitative part, a positive urine screen, we find that at least rheumatologists, it's slightly different with nephrologists, but rheumatologists, when they see a low level of proteinuria, don't qualify it as lupus nephritis and treat it aggressively, which is surprising. And I think we need to you know, I think we have the support of the guideline bodies and, you know, the ACR and the nephrology groups, we need to educate on why it's important to treat at those lower levels. But if you just look at what's happened up to this point, at lower levels of proteinuria, rheumatologists don't seem apt to treat aggressively. Okay, I find that surprising, but okay. So you identify it as an issue. You have so far, you've educated your sales force in that regard. How are you tracking how these rheumatologists are starting to treat based on your messaging? Is it changing, or is it just like the urine test, we haven't seen any evidence of it yet? Well, back to go backwards a little bit on the urine test, the evidence we have seen is that our messaging is impacting docs, and their intent to do better is there, but it actually has to start materializing Yeah in the day-to-day practice. While I can tell you that we track it two ways. We track just ongoing, pretty sizable attitude and awareness of rheumatologists and nephrologists. We ask them the questions, they answer back. We've seen those trends, whether it's rheumatologists treating the disease, diagnosing the disease, or treating to target, all of those say to us that physicians are going to change how they're treating the disease. Where we track is it happening comes down to blinded patient record audits, looking at ICD-10 coding. We get big samples of that. We pull it in, we look at it. Whether it's MMF, MMF and steroids in combination, Benlysta, our drug, they don't appear to be doing it yet. So I think we just have to continue to work on it and move that attitude to actualization in the coding, and obviously, for the patients who go on our drug, we can track all the detail that's behind when they're getting the drug, why they're getting the drug. Okay, so when you do think about this patient population, and there are many more that should be diagnosed, but those that are actually being treated right now, what do you believe your market share is right now for the drug relative to other options that are available and being used to treat these patients? Yeah, just to recount sort of how we see the Yeah broader market, we believe there's probably somewhere in the US, somewhere between 80,000 and 120,000 patients- Sure that suffer from the disease, but that's at the highest level. When you actually get into the percentage that are diagnosed, you probably have to almost half that number, and then if you use the data that you just mentioned, that 30% number of who’s treated, you're taking half of that population, and then you're cutting it down to approximately 30% that are treated. That's how we look at it from almost an epidemiology standpoint, but we've also cross-referenced that versus, you know, coding data that's out there. Our penetration into the treated market is actually quite good. We've not given direct market share numbers because the question comes down to like, okay, what is the market? Is it, you know, just novels? Is it, like us and Benlysta, which, you know, about From what we see, about half of those patients treated with novels are treated with Benlysta and, or treated with our drug. The problem with that data is you've got to look back to when they actually started Benlysta, and because the drug is approved for the treatment of lupus, a lot of times they'll change a code, but the patient's been on Benlysta for their lupus, and then they just continue and keep them on the drug. So there's a little bit of, I don't know, dicing through the data we need to do to actually know what a newly diagnosed, new-to-drug patient is on Benlysta. But I think if you look at the percentage of all patients treated, whether it's on MMF and steroids, other modalities that are out there that are not approved, you know, depending on the data pool, we've got pretty solid market share, and we've not, as I said, we've not given the exact numbers, but you can do that breakdown I've just given you. Yeah and say, "Okay, well, we've had treated to date somewhere around 4,000-5,000 patients. We actively have on drug well north of 2,000 patients, as reported last quarter, and if 30% of that breakdown is actually being treated," you can do the math as to what our penetration has been. Okay. When you look at that 4,000-5,000 patients then, how many of those would have been treated with Benlysta prior to that, if you know so much about these patients? Not as many as you would think. I don't know that I have the exact percentage of lupus patients that we see that have been on a B-cell inhibitor, because I think broadly you have to now think about, well, it's Benlysta, yes, but there's also Saphnelo Yeah AstraZeneca's product, and then there'll be other B-cell inhibitors coming down the road. What I can tell you is, regardless of what they're being treated for in their lupus, they still see breakthrough proteinuria. So I think that opportunity is still very large today, and it's going to grow even more when we see better diagnosis and more aggressive treatment. Okay. Maybe we can spend a little bit of time on persistent rates and those sorts of things at 12, 15, 18 months. They're ticking up a bit, it seems, every single quarter. That, that's obviously positive, but can you walk us through that and where you'd see things, you know, ending perhaps at the end of the year? Yeah, I mean, we haven't given a forward projection on persistency. I can just report on what we've seen. Yeah. I think in the first year we launched the drug, you know, to be at or around 50% at one year was where we were, 50% of patients who continued on the drug. Since having which actually benchmarked in other disease categories, other arthropathies, MS, etc and novel drug treatment, 50% is pretty good for some of these analog chronic treatments or chronic diseases that are out there. Since having the extension data, the biopsy data, the full complement of data out there, we've seen those numbers tick up, you know, 5%-6% Mm over the last three years. And you might say, "Well, is that meaningful, right?" Sure, it's very meaningful- Sure because, I mean, we actually are seeing growth from our product happen in really two ways: new patients coming onto therapy, and then patients staying on therapy over time, and those percentages growing have been very helpful to us. Not only at 12 months have we seen that improvement, we've seen sort of a flattening off that's happened after 12 months, at about 18 months, where the reduction all the way out to 18 months is not that significant. You see about a 10%-15% decline in terms of what the persistency rate looks like, but then it seems to hold. Again, meaningful to, at least for obviously, we're a public company, we revenue is important. That's a meaningful metric for us to be looking at. It's also more meaningful because you're starting to see patients get more consistent performance against what the guidelines are, are trying to drive, which is patients keeping proteinuria in check over time. Always can be better. The data's gonna help us here. It's threaded throughout our message, but we've seen, you know, at 12 months, almost a 5%-6% improvement over time. Right. And so let's switch over to the hospital environment, where that's something a bit newer, and you've obviously been successful there. Is there any update on the integrated healthcare networks or anything like that that you'd like to share? Well, we have a strategy there, and you know, we launched this product right in the heart of the global pandemic and COVID. So a lot of the hospitals, for at least a year, if not a year and a half, were completely closed. Sure to actively having sales reps in there. Since that time period, we've, that has opened more for us. It's much more accessible. We have a group of all of our reps have access to hospitals, but we put together a core group of folks within the company that are only focused on this area. One, we have not, at least at this stage, made the decision to go in and directly contract with these integrated healthcare networks, although clearly, that's a piece of the component that we need to consider over time. There's gaining the formulary acceptances, and then, of course, there's how we interact with the lupus clinics that are there, the patients who are diagnosed acutely in the hospital. It's been progressing. The numbers, obviously, we report now on a quarterly basis, and they went from being immaterial, really having no product shipped to hospitals, to, you know, over the last couple of quarters, we've seen a couple 10, 10 patients here and there that are starting to come out of that environment. The two ways we're gonna capture patients in the hospital network is, one, they come in with acute presentation or are diagnosed in, like an emergency department setting. We're not calling on emergency departments, but if we're on formulary, we become accessible there. And more importantly, at the major medical academic institutions, they have lupus clinics, and if they bring in 60 or 70 patients to a lupus clinic, and those patients actually get a urine screen, we hopefully can capture more patients there as well. Drugs available at many of these institutions, we have a strategy. We're starting to grow. We're optimistic it'll continue in that direction. Okay, so we have about five minutes left, and I thought that we maybe could spend a second on the guidance that you've provided to $200-$220. Q1 was good, but can you talk about the factors that are gonna influence whether we are at the lower end of that range or the higher end of that guidance? Yeah, I don't wanna oversimplify the answer, so I'll start there and see what you dig into. But if you look at our first quarter performance, if we were to just flatline for the rest of the year, we're at the low end of our range. So I think that in order to achieve the low end of our range, we would just need to stay consistent. We've seen historically a little bit of a summer, I don't wanna call it seasonality, but because we're not an antiviral, we're not an antibiotic of sorts, and we're clearly not in the allergy space, so it's not what- Mm what most would qualify as a true seasonality, but during the summertime, we've seen a dip in our business- Sure for the last three years. So, I think you got to factor that into thinking, and when you think about the upper side of our guidance range at $220 and beyond, we would have to see consistent performance, Q1, Q2, continued growth. We'd have to see a solid summer performance, at very least, sort of a flattening of our business in the summer and coming back to growth in the fourth quarter. And then I think you have every ability to be well, you know, at the top end of that range or above that range. So we've got a, you know, a very aggressive, get out there summer campaign. We've done that every year. We'll continue to throw more tactics at the summertime to try to ensure that we, at very least, see, you know, a stabilization of that business in the summertime and come back to growth in the fourth quarter. Okay, what I want to wrap up with is, and this is gonna be complicated, is just intellectual property. I don't think it's a stumbling block in terms of your capabilities to bring this drug and penetrate the market. I think LUPKYNIS is a very good drug. But I do think in terms of value creation, people need to understand your position on the IP side, when you're expecting Paragraph IV filers, probably next January, et cetera, et cetera. Maybe you could just walk us through that and why you feel confident in your position. Yeah, I guess the best place to start is, you know, where the range of our patents are, and to start, you know, the benefits we got around Hatch-Waxman on top of our composition of matter, bring the product with our patent term extensions annually to probably July of 2028. That's sort of your worst case scenario. Yes, eventually you'll have Paragraph IV filers, but even if they were to beat us- Yeah July of 2028 is a worst-case scenario. As I say to many of our investors, it's like, run the math on our cash on hand, the fact that we are, moving to cash flow positivity in Q2, project that forward with a growing brand and look at what the accumulation could be on our balance sheet of cash out to 2028, and there's a disconnect somewhat on, on value, even in the worst case scenario. We have, in addition to that, two patents and more patents on file that we don't talk about until they're actually accepted and issued. two patents that focus on the method of use- Mm-hmm of the product. That was done in both the exploratory studies, the phase II AURA study and the phase III AURORA study, where we had this lowering of, based on eGFR response of the patient, the dose of the drug, and when doing that, we actually saw an improvement in efficacy, which created a host of novel patents. Those patents go all the way out to 2037. You know, those patents, we believe, are very strong. They're method of use patents, much like formulation patents and other patents. Sure. Could they be challenged? Of course. But we think right now we're not getting credit for, you know, the strength Anything beyond of those patents in any way. But I think you have to look at it across the full continuum of what our patent portfolio looks like. Perfect. I think with that, five seconds left. Thank you very much. It was great. Thanks for having me. I hope to see you again next year. Great. Thank you. Excellent. Peter.