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spk09: Mari Raycroft at Jefferies. Dr. Raycroft, your line is open.
spk10: Hi, good morning. Congrats on the progress and thanks for taking my questions. Let's see, so just wondering if you can elaborate on patient discontinuations that you mentioned in your 4Q update. Are these transient compliance issues or related to how the doctor is managing the patient or are there any other insights or explanations you can provide at this point?
spk08: Yeah, I'm going to ask Max to join me on that conversation. I think my answer would be it's across the board. And we're providing six months of data because we have a healthy number of patients who have crossed six months of therapy. Obviously, since we launched at the end of January, the number of patients seeing 12 months of therapy is lighter. So, as we go forward, we'll start to give longer-term views on that. But, Max, you want to give any color as to, you know, why patients, you know, the 30% or so might be falling off the product? Yes, sure.
spk02: Sure. Thanks for the question, Maury. And I'll make one more point before commenting that, which is that 30% discontinuation at six months, we've seen that now consistently. for a couple quarters here. So in terms of reasons for discontinuation, I would say that it's really the typical reasons that you would expect patients discontinuing. As a start, there's tolerability issues for some patients that show up early in the treatment, and that's the primary reasons that patients will discontinue. I'll make just one more point, Maury, which was, you know, we talked about that there was, you know, above and beyond just the discontinuation, there was just this temporary impact in the beginning of the quarter on refill rates. And that was outside of the kind of the discontinuation. And then, as I noted, that just rebounded. And really what we see now is consistent discontinuation with what we saw in the fourth quarter.
spk10: Got it. Okay. And so presumably outside of the safety or tolerability, some of these patients could actually come back onto therapy. Is that the right way to think about it?
spk08: We've seen even just tracking analog products like MMF and others that patients do. It's not in the guidelines, but patients do cycle on and off of products. And I think one way to explain that would be a patient you know, stops taking therapy, finally sees their doctor, doctor says your proteinuria is still high, start taking your therapy again. So, you know, they can come back. It's not like we see this as once they've seen the product, they're considered a non-responder or something and don't come back and, you know, we're not getting reasons coming back to us saying the patient's proteinuria wasn't under control. A lot of these are patient-driven decisions, and we'll have to continue to, and you heard that we have an increase in our focus on the patient, educating the patient, and all of that pertains to education on disease itself, importance to stay on your medication and keep on your medication over time.
spk10: Got it. That's really helpful perspective. And then just wondering if you can talk more about what you're seeing with pricing metrics and what your latest assumptions are.
spk08: Well, as we said, we're giving an average net in the first year of launch at or around this 65,000 net per year per patient. As we indicated in the quarter, it's been above that. We haven't given specifics because the last thing that we really want you to do is plug in a number that's had variability and then carry that forward and then it changes. The one thing we do know is that we believe it will continue to migrate towards that average net and that's why we're sticking pretty consistent to that. Adherence, once a patient goes on drug, Maury, has been at around 80%. So if they're on the prescription, they're staying on it. And that's a good thing in terms of looking at your average monthly number of doses, et cetera. So, you know, as we've said, average net has been higher than 65, but we think it's a safe bet to land on 65 at this stage until we just have more data. Because mix of patients, depending on insurance carrier, public versus private pay, how much EGFR dosing is utilized, and adherence are all going to vary over time.
spk10: Got it. Okay. Makes sense. Thanks for taking my questions.
spk08: Thanks, Maureen.
spk09: Coming up next, the question to follow is Stacy Koo at Cowan & Company. Your line is open. Please go ahead.
spk05: Hi, good morning. Congrats on the quarter, and thanks for taking our questions. So first, a really specific one on the patient start form addition. From our map and your comments from last quarter, we're seeing roughly 260 patient start forms that we added in March. So just wanted to confirm that. And what are you seeing in terms of the cadence of kind of quarter over quarter patient start forms? What are you seeing in Q2 so far? How should we be thinking about the March additions? Is that a run rate or are you seeing more growth from that number? So that's your first question. The second question is, If you could talk about repeat prescribers. So once they've kind of figured out how to use lupkinase, they've written for lupkinase, they're getting good, they're happy with kind of the efficacy, maybe the palatability profile. What kind of metrics do we want to provide around those that kind of have adopted versus those that are still kind of waiting and seeing? So those are our two questions. Thank you.
spk08: Let me start with PSFs and have Joe Miller just make sure I'm honest with the math. What we said was we didn't give the exact number for March, but just told you that in March we had our highest yet. And I don't know, Joe, did you count what she said, 260?
spk07: That's a little bit high. We gave kind of an average number coming into year-end earnings. It wasn't the full February through the end of the month when we did that number. So you're a little bit high on March. But overall, as you kind of look at monthly run rates, March was our highest month to date.
spk08: Yeah, and then what I would say about quarter, we report, and we've consistently done this, we'll give you the end of quarter number, but then we'll always give you, depending on when we do the earnings call, we'll give you the most up-to-date PSF number. And that's what we gave you as of Friday of last week. And that was, what was the number we reported? It's here today, 647. What I can tell you about that number, Stacy, is it is on track with or growing ahead of where we were in Q4, which is what I think you want to see. You want to see consistent quarter-on-quarter growth. And as we noted, we saw a slight dip from Q4 to Q1. and then we're seeing growth that's representative growth over q4 so far into q2 and that's right on track with where we want to be in terms of your question on prescriber habits and repeat prescribers let me share just a couple things here and just for being expedient here you know kind of cover off on this for max um One, yes, prescribers are more apt to use the product once they've used it. So we do see strong secondary prescribing. And so from after initial prescription, repeat prescribing is quite high and consistent. Second, obviously, we decile our docs. And in our top decile docs, our penetration increase and continues to grow. And to put that into perspective, the top tier docs have, in some cases, 10 to 12 times the number of patients. And we're talking a small number of patients per doc, but then the average lower decile. And our penetration there has continued to grow. As we get, you know, over the next couple quarters, you know, we'll continue to share more as to what both our depth and breadth of prescribers look like. But we've been quite happy, based upon our deployment with our sales force, as to what our penetration's been in the highest deciles, the breadth of our prescribing, and then, more importantly, the depth. Physicians are reusing the drug after start, more apt to once they do.
spk05: That's very helpful. Thanks again.
spk09: Our next question today will come from Ed Arce at HC Wainwright. Please go ahead.
spk11: Hi, everyone. Thanks for taking my questions. Can you hear me okay?
spk08: Sure can.
spk11: Great. A few questions for me. I wanted to ask, well, you mentioned in release the PSF conversion rates at about 80% after 90 days. My question is if you could describe for us the, for that conversion, the average period from the PSF to treatment on average, what does that look like? And then wondering now that you've had over a year now experience with patients. Any lessons learned so far as you work on keeping patients on therapy, the consistency, the persistence, compliance, obviously towards not just refill rates, but staying consistent. Any lessons learned there and perspectives you could share? And then lastly, Regarding the $30 million, up to $30 million in potential milestones from Atsuka, potentially later this year from the EU approval, is there any details you could provide on to the split and what would be required in terms of labeling and so forth? And then I have a follow-up. Thank you.
spk08: okay and i'll go backwards on this because as you go through those lists usually the last one's the first one on my mind so on the 30 million from atsuka here's what we've said historically the closer we come to a match of the u.s label the closer we'll be assured to a 30 million dollar payment the range of up to 30 million dollars is all comes down to how the label comes together and duration of utilization. So meaning if the product were by the EMA said to be a therapy that can only be used for three to six months, the payment would be lower. That's all the color I can give you on up to 30. But the closer it comes to match the U.S., the closer you can be assured that 30 million is the number we would see. And so far, in our conversations, both at 120 and 157 days, and conversations with the raptor and co-raptor, we don't see any showstoppers here. So we feel good about it. You know, the PSF conversion rate, and then let me go to lessons learned because I want Max's input there. I have plenty, but, you know, you asked specifically about patients, and I think we should give you our color there. PSF conversion rate on average. We are above, at 30 days, more than 50% of patients are converting onto drugs. So we give you a 90% number, which was 80%, a 90-day number, but at 30 days, more than 50, almost up to over 60, are on drugs. So they get on pretty quick. We're improving, as I've said historically, we're looking at 30, we're looking at even pre-30, but the important ones are 30, 60, and 90 days. And we want to have as many converted within that 90-day period as possible. And I think we're getting to a point of almost like, I mean, 100% perfection and we're at 80. and we want to get them on faster. And now to be up over 60% at 30 days is we're on track with where we want to be. Lastly, on lessons learned with patients, I'll just emphasize that it's critical and that because this disease presents with no physical signs and symptoms, There is no natural patient quality of life indicator that forces a patient to stay on drugs. If your joints hurt, you're more apt to stay on a biologic therapy for rheumatoid arthritis because it's helping your joints. Lupus nephritis is a quiet disease until it's not. And we need the healthcare providers. We need the patients to be educated on the overall impact of the disease. and we need the patients themselves to be overly educated to stay on therapy because their kidneys and potentially you know um because of what the data shows if the disease progresses their lives may be at risk so patient education patient support programs um are are continuing to be paramount and as we mentioned in the call script we're increasing our investment there max yeah i mean what i would add and i think peter hit the nail on the head what i would add is that we have improved our processing speed every quarter
spk02: We are, you know, having more than 80% adherence rate is significant for this patient population. And really the key, as Peter highlighted, is education. We put significant resources in Orinia Alliance, our case management team that connects with patients. on a regular basis. We put significant resources in support of physician offices and academic centers to ensure that patient star forms are converted fast, and those investments are bearing fruit in speeding up conversion and also helping patients stay on treatment.
spk11: That's great. Thank you. That's helpful. Just one more follow-up for me. You mentioned the vocal pediatric study underway in enrolling patients. Just wondering if you could delineate for us any other post-approval commitments so we could be aware of what's coming up down the line. Thanks so much.
spk08: Yeah, as previously mentioned here, Ed, and just a reminder for everyone on the call, our post-marketing commitments were, one, the Aurora 2 extension data, which has been shared with the agency and the EMA and is part of our application in the EMA. The vocal pede study, which is a pediatric study, obviously, which is ongoing. And then lastly, there was a lactation study and I think a drug-on-drug interaction study. One has been completed. The lactation study is ongoing. The pede study is ongoing. And we'll report out on those over time. As I said, the drug-to-drug interaction study has, I believe, been submitted at this stage, completed and submitted. The Aurora 2 has been submitted, and then the VocalPede study will take some time. Obviously, this is primarily a disease that affects middle-aged females, so getting down into a younger audience will take time, but we have all the belief that we can do that. Those are our commitments, Ed, and we continue to, through the ENLIGHT-LN study, invest in further research both on the higher level, like a global registry, and secondarily with individual investigator-initiated studies and things of that nature to support understanding the therapy in the real-world environment.
spk11: Great. Thanks so much, Peter. Thanks, Ed.
spk09: Next we'll hear from the line of Sahil Dhingra at RBC.
spk01: Hi, this is Sahil. Hi, good morning. This is Sahil for . Thank you for taking my questions. My first question is can you please elaborate on the quarter-on-quarter decline in revenues? When I look at the total number of patients on therapy, they have increased from 884 at the end of the year by end of Q122. So is it a function of refills or is it a function like you have more patients on EGFR that is driving the revenues lower quarter on quarter? Can you please comment on that? And then I have a follow up.
spk08: I'm not sure I understand the question. You're asking about the net price per patient or you're asking, the patients have, accumulated patients have grown. What are you pointing at that I just need to understand and have you clarify a little more? Am I sure I get it?
spk01: So in the press release, it was mentioned that there were 884 patients at the end of Q4, at the end of 2021, and 1,071 at the end of March 22. So there are net additions to patients, but the revenues have declined. So I just wanted to understand is it a function of lower refills during Q1 or is it like there are more patients on the dose reduction program or is it anything else?
spk08: Yeah, so as we said, because I got it now. You're just doing the straight line math. You're saying the question is, if you had 884 and you grew a net 200 patients, why would the quarter be down? And what you're not taking into account there is one is a patient growth number. You also have to look at refill rates. And as we mentioned, with patient insurer plan changes, with the COVID impact and patients not picking up prescriptions due to that, as we mentioned in the call, that your refill rates were lower. So even though we increased the number, the net revenue per patient in the quarter went down. And then we'll see that hopefully in the next quarter buoy up. Partially why we try to keep consistent on this net revenue number because in a quarter like this, obviously we saw a dip primarily due to refills. So the simple answer for you there is it's based on refill rate per patient.
spk01: And the patients on dose reduction that are consistent with the prior quarter?
spk08: Yeah, we haven't seen any dramatic changes there. And, yeah, I would not look to Q1 as anything significant happened with dose adjusting on patients. We've seen pretty consistent at or around what we saw in our clinical trials so far in practice in the market.
spk01: Okay. And I have one more question. Earlier you had mentioned that the discontinuation rate which happens within three months the patient is on the drug. That was around 25 to 30%. And today you have commented on, for six months, a compliance rate, which is around 70%. So when we're looking at net patients, should we deduct both of them individually, or is it combined?
spk08: No. What we've done is we originally, when we did not give data for six months or 12 months, was we gave you the best grouping of data we had, which was what happens at 90 days. On a go-forward basis, you should look at our persistency numbers that we give. Like at six months, 70% of patients that get on drug remain on drug as being one number inclusive of those who have actually discontinued drug in the first 90 days. So it's not a double hit.
spk01: Great. Thank you so much for clarifying my questions. That is all from my end.
spk08: Thank you.
spk03: and moving forward our next question comes from david martin at bloom burton yes good morning uh most of my questions morning uh most of my questions being asked but i'll go back to a couple i've had in previous quarters um the doctors that are using are prescribing the kindness are they also prescribing generally ben lista or do they tend to pick one or the other and if they're prescribing both drugs, any insight yet as to which patients they decide to give Leukinus and which they decide to give Ben-Lesta?
spk02: Yeah, thanks for the question. And, you know, the answer to that question is pretty consistent with what we've said in the past, which is, you know, really when we talk with rheumatologists they think about Benlista and Lufkinis for different types of patients. And really, there's almost a different positioning as they think about what the patient's manifestations are, their level of proteinuria, their lupus health state, and how they think about whether to use Lufkinis or Benlista. But we've also, what we've seen in nephrology is a stronger presence. for lupinus, then Benlista. And that comes from just their general experience also with prior generation CNIs.
spk08: Yeah, I think for me on this one, and it's tough in the data to really break through. Rheumatologists have the ability to use Benlista for the treatment of lupus. So sometimes they keep a lupus patient on as they get lupus nephritis. Sometimes they initiate Benlista when the patient has lupus nephritis. And it seems to us that even the rheumatologist is selecting the patients when they get lupus nephritis for a new patient to when they use Benlista or when they use our drug. And then the good thing is in nephrology, we're getting preferential right now. We'll keep you posted on how those numbers move moving forward.
spk03: Okay. Patients with newly diagnosed lupus nephritis, are the doctors waiting until they fail MNF and steroids before they put them on lute kinase, or is it first-line combination?
spk08: Well, I think our greatest tracking towards success, and what we've said is our goal is to change the treatment paradigm, is to track over time the amount of patients who start receiving lubekinase in combination with MMF and steroids as first-line therapy. But as you can appreciate, David, these patients are coming in, the majority of these patients that are in the diagnosed and treated population are going to be on MMF and steroids first. So we are seeing growth in newly diagnosed patients, but it's a smaller percentage of the end, and we're going to track it over time. The majority of our patients have seen a course or are currently on MMF and steroids, and our drug is added to the equation, which is as predicted.
spk03: Okay, and last question. Are doctors keeping the patients on Leukinus only if they achieve a complete remission or is just a lowering of proteinuria a partial remission good enough to keep them on?
spk08: Yeah, I don't know that we sort of longitudinally track you know, protein urea rates on a monthly or... We can only give you what we hear anecdotally, and I'll pitch it to Max to give you what we're hearing from the docs.
spk02: Yeah, and what we're hearing from the docs is that they're looking for protein urea, you know, decreased. overall, and they're, you know, they reach a certain level of, they're happy with a 50% decrease in proteinuria, and clearly their goal is to get to a complete response. But they don't stop treatment. You know, the goal is to get proteinuria down.
spk08: Okay. And recall, in most cases, David, they're adding R-drug to the mix. So you're getting an incremental benefit over the current standard of care for the majority of patients.
spk03: Okay, great. And I do have one other question. When you say adding it to the mix, these patients with lupus that are already on Ben Lista, Are you seeing lupinus being layered on top?
spk08: We have not seen that yet, although our thought leader base talks about whether a strategy in combination with CNI and B-cell inhibition could be an approach. But that's one that's talked about hypothetically as a treatment strategy. We do not see that in practice right now, at least in our data.
spk03: Okay, got it. Thank you, that's it.
spk08: Thanks, David.
spk09: And now we'll hear from Justin Kim at Oppenheimer.
spk06: Hi, good morning, and thanks for taking the questions. Maybe just to follow up on Stacey's prior question, you know, our math seems to suggest a pretty stable quarterly script number between fourth quarter through even our estimate of the 2Q run rate So just trying to understand, you know, what the team expects for maybe those numbers to shift or change as you, you know, look to maybe reach the high end of guidance and, you know, whether it's macro factors or sort of micro with like the sort of physician practices and that's the prescription. Can you walk us through how you think about those script numbers changing or maybe not changing over the balance of the year?
spk08: Well, I think if you look at the total number of prescription start forms that were produced in Q4, and you look at Q1, it was down slightly. And when I say slightly, Joe, what are we talking? It's tens of patients. It's not like 200 patients. So as we move into Q2, we are back at least in a run rate. And again, we don't give quarterly projections on PSFs, but directionally, we're back in a growth trajectory over Q4. So that's where we want to be. We haven't given, but you can probably do your own estimated math on if you believe 70% of patients on are at six months and make an assumption on where they are at 12 months, you carry a prescription Starform rate into the quarter and figure back what our nutrition rate could look like in a quarter, what our growth in PSS have to be, you also can estimate what the retentive rate can be. And maybe there are improvements there. All I can tell you is the way we think about it is the retentive rates we're working on, we want to continue to improve on. But if we held them steady, what would the prescription start form rate have to be in order to achieve growth numbers from Q4 numbers where we were into Q2. Because from a pure revenue standpoint, the numbers from Q2 have to be bigger, obviously, than where we were in Q4, not based off of where we are in Q1. So they have to grow above Q4. And then seeing that growth continue throughout the year. And multiple assumptions there around continued opening, prescription start form activity, refills,
spk06: throughout our entire model and our execution it's not one factor okay okay got it um and and does the team have any updated observations or thinking around how this kinase is being administered beyond maybe the 12-month time point um you know just having onboarded several hundred patients in the commercial setting who could have reached this point
spk08: Yeah, I mean, to me the magical question is what's it going to be in 12 months and then what's it going to be in 18 and 24 months? You know, we benchmarked this, by the way, against biologics and other indications, other rare diseases, et cetera. But in all honesty, just like before, we'd rather report 12-month numbers when we have a significant end of patients that are on the drug. And, you know, through this, through six months, we actually had several hundred patients who had seen the drug at that point. The number is small at 12 months. But I think it's fair to say that our assumption would be that if you're at 70% at six months, you're probably going to be less than that at 12 months. That's just a natural way the business over time will progress and probably less at 18 and less at 24. It's just a matter of what it is. So, you know, Justin, we can't comment on it outside to say, you know, we'll report it when we have a sizable enough end, which each quarter it grows. so that we can give you something that we think is going to be consistent and projectable, and that, generally speaking, we believe it will continue to decline. It's just decline at what rate.
spk06: Okay. And maybe just a final question, if I can squeeze one in, is, you know, taking a look at the abstracts at ERA, you know, we're just kind of curious if there was any observations on the duration of therapy and time to renal response observed commercially, just So I'm curious, you know, with some of the data around pure class five taking longer time to reach renal responses, is that sort of mix of patients being observed maybe as you look at sort of those population sets at later and later time points that maybe they are, you know, falling into one class or another?
spk08: I think you stepped right into the reason we're doing a vocal study, so that we can track prospectively some of those numbers, like in real world what the time to renal response actually looks like. So I can't give you what the time to renal response or the ELITE LN registry, sorry, I think I said vocal. So I can't give you what real world evidence shows in terms of time to renal response, but Dr. Solomon's on the phone. He can probably give a little bit more on the abstract specifically you're talking about. Neil, you want to give any commentary if you heard the question?
spk04: Yeah, I wasn't quite sure exactly what it was you're asking. I think you were saying, did you have any differential information around how quickly classifiers respond compared to proliferative patients? Was that the question?
spk06: So just around whether the time to response is or maybe just class in general and severity of disease is sort of observed as different among the various populations at various time frames. So are patients at longer-term duration therapy potentially more severe in disease and in the commercial setting and whether there are any trends observed as to
spk04: Yeah, I mean, yeah, I think what Pete said about in the real world and the registry is going to give us a wealth of information around that. And I think that's the reason we're doing it. but you know there's so many things at play and of course when you look at the abstracts and the data that's been presented you know only 15% of the patients that went in for example to the Aurora trial and also Aura trials were class 5 so we're kind of looking at relatively small you know populations of patients I think we just don't have enough knowledge at this point, and it'll become more obvious as we do more and more cuts in light and registry. So, yeah, I mean, that's all we have at this point.
spk06: Understood. Thanks.
spk08: All right. So I want to thank everyone for joining us for the call today. I think with that last question, that concludes our Q1 earnings. Thank you for the time, and have a good day.
spk09: Ladies and gentlemen, this does conclude today's Arrhenia Pharmaceuticals first quarter 2022 financial and operational results conference call. You may now disconnect your lines, and we hope that you enjoy the rest of your day.
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