Aurinia Pharmaceuticals Inc (AUPH) 2025 Q4 法說會逐字稿

Good morning. Welcome to the Aurinia Pharmaceuticals fourth quarter and full year 2025 conference call. (Operator Instructions) I will now turn the call over to Peter Greenleaf, President and Chief Executive Officer of Aurinia. Peter, please go ahead.

Good morning. We want to thank you all for joining us today to discuss Aurinia’s fourth quarter and full year 2025 update. Joining me on the call today are Joe Miller, our Chief Financial Officer, and Dr. Greg Keenan, our Chief Medical Officer.

On today's call, we will report fourth quarter and full year 2025 financial results and provide an update on recent business progress. During today's call, we may make forward-looking statements based on current expectations. These forward-looking statements are subject to a number of significant risks and uncertainties, and actual results may differ materially.

We are pleased to have delivered strong LUPKYNIS sales in 2025, growing at a rate of 25% year over year. And for 2026, we expect net product sales of $305 million to $315 million, up 12% to 16% compared to 2025.

And with that introduction, I'd like to now turn the call over to Joe to review our financial results, Joe.

Thank you, Peter. Total revenue for the fourth quarter of 2025 was $77.1 million, up 29% compared to $59.9 million for the same period of 2024. Net product sales of LUPKYNIS for the fourth quarter of 2025 were $74.2 million, up 29% compared to $57.6 million in 2024.

Net income for the fourth quarter of 2025 was $210.8 million up 14,957% from $1.4 million in 2024. In the fourth quarter of 2025, the company recorded an income tax benefit of $175.1 million primarily due to the release of its valuation allowance on deferred tax assets that the company now expects to realize.

Net income before income taxes for the fourth quarter of 2025 was $35.7 million, up 2,875% from $1.2 million in 2024. Diluted earnings per share for the fourth quarter of 2025 was $1.53, up 15,200% from $0.01 in 2024. Lastly, cash flows from operating activities for the fourth quarter of 2025 were $45.7 million, up 52% from $30.1 million in 2024. Total revenue for the year ended December 31, 2025, was$283.1 million, up 20% compared to the $235.1 million for the same period of 2024.

As a reminder, the 2024 period included a milestone payment of $10 million associated with LUPKYNIS regulatory approval in Japan. Excluding the one-time milestone, total revenue increased by 26% over the same period in 2024. Net product sales of LUPKYNIS for the year ended December 31, 2025, were $271.3 million, up 25% from $216.2 million in 2024.

Net income for the year ended December 31, 2025, was $287.2 million up 4,852% from $5.8 million in 2024. For the year end of December 31, 2025, the company recorded an income tax benefit of $173 million primarily due to the release of its valuation allowance on deferred tax assets that the company now expects to realize.

Net income before income taxes for the year ended December 31, 2025, was $114.2 million, up 1,443% from $7.4 million in 2024. Diluted earnings per share for the year ended December 31, 2025, was $2.07 up 5,075% from $0.04 in 2024.

Lastly, cash flows from operating activities for the year end of December 31, 2025, were $135.7 million, up 206% from $44.4 million in 2024. As of December 31, 2025, the company had cash equivalents, restricted cash and investments of $398 million compared to $358.5 million on December 31, 2024.

For the year ended December 31, 2025, the company repurchased $12.2 million common shares for $98.2 million and fully diluted shares outstanding were reduced from $149.8 million to $139.7 million. As a result of LUPKYNIS continued momentum, we are pleased to announce our 2026 guidance. We expect total revenue of $315 million to $325 million up 11% to 15% compared to 2025.

We expect net product sales of $305 million to $315 million of 12% to 16% compared to 2025. Now I would like to turn the call back over to Peter for some business updates.

Thanks, Joe. Turning now to aritinercept, we are very excited about the potential of this novel biologic in the treatment of a wide range of autoimmune diseases. As we've previously discussed, aritinercept is a dual BAFF/APRIL inhibitor that was well tolerated at all dose levels tested in a phase one single ascending dose study.

Single doses of aritinercept led to robust and long-lasting reductions in immunoglobulins, supportive of once monthly dosing. Aurinia has initiated a clinical study of arintercept in one autoimmune disease and plans to initiate a clinical study in an additional autoimmune disease in the first half of 2026.

In summary, we continue to drive growth in our commercial LUPKYNIS business while at the same time advancing the clinical development of aritinercept.

We want to thank you for joining us on today's call, and we look forward to taking your questions. Now, let me ask the operator to open up the line for Q&A. Operator.

Certainly, when I'll be conducting a question-and-answer session.

(Operator Instructions) Maury Raycroft from Jefferies

Good morning. This is Farzin Jefferies. Thank you for taking our questions. So, your issued guidance for 2026 seems somewhat conservative given the 4Q run rate. So what are some of the specifics informing the commercial outlook and as it relates to what you're seeing in the first two months of this year?

Farzin, on the first part, I don't think I got the first part of your question. Can you repeat it or what you're looking for there? I think you want to understand that what's underlying the growth for the company for the year.

Right, like the what's underlying assumptions for the 2026 guidance and then what are you seeing in the first two months of the year to inform that?

Well, I think first off, our strategy for the commercial business of LUPKYNIS continues to be similar to what we've done, for the last probably 6 to 12 months. That's to continue to stand on the incredible data that we have in terms of the efficacy of the product and the treatment of lupus nephritis and the reduction of proteinuria as early as three and six months that we've seen leveraging the expanded data set that we had with the extension study we did with the aurora trial which gives longer-term data, the biopsy study.

And then last year the introduction of the ACR and EULAR guidelines that actually did a really nice job not just promoting. Novel products like LUPKYNIS, but more importantly, more aggressively using diagnostics to identify proteinuria earlier in patients suffering from lupus to identify lupus nephritis. So, our strategy hinges on really trying to change the whole treatment paradigm, the diagnostic paradigm, and then the early treatment aggressively of proteinuria.

We believe our drug does that better than the drugs that have historically been used to treat the disease and what's been seen to date with even the novel newly approved or novel drugs that have produced data. As for the question about the first two months of the year, we're not really giving any steer for the quarter,

but I, nothing's out of the ordinary for what we've seen, historically. We've tried to put emphasis on the best predictor for what we're seeing going forward has been past history. We would refer you to Q1 of 2025 to look for any trends in the business.

Correct. Makes sense. And then a follow-up is on the, you recently terminated the phase 3 and the open level studies in the vocal study and the vocal extension, the pediatric study, and it mentioned like part DSMB recommendations. So can you clarify whether DSMB is asking to stop or is FDA refocused on the drug in any way?

You want to take that, Greg?

Yeah, thanks for the questions, Greg Keenan here. So, the vocal study in its current form was one where, due to technical issues working with the clinicians, it proved to be very difficult to recruit patients for that particular. Study, so we made a decision based on what we saw at that point that we terminate the study and plan to have negotiations soon with the FDA for further plans for meeting our pediatric commitments in lupus nephritis.

Yeah, I think just one thing to add in addition to that is we have data from the work that we've done up to this point. We have in-market data that we know from treatment of patients both on the adolescent and the pediatric side in the current market. So there's data that we can actually provide to the agency, and we look forward to a conversation with the agency about one, meeting the commitment that we had to the agency, and 2, what that would mean for how physicians should be guided. In the treatment of pediatric patients. Last point here, remember that this disease is primarily a disease of women in the middle part of their life, not, it's not really a prominent pediatric condition.

So while we have the commitment with the agency, this is not the burden of this disease in pediatric patients is quite small, and thereby the business opportunity being probably even smaller than that.

Next question.

Thank you.

(Operator Instructions) Joseph Schwartz from Leering Partners. Your line is now live.

Hey guys, this is Will Sawicki on for Joseph Schwartz. Congrats on the quarter and thanks for taking our questions. So just to start for us, I think previously you guys got into a development update for our aritinercept in early 2026.

So, can we still expect this update? and could you please provide some additional context for what this might entail? I understand that for competitive reasons you're keeping the indications of focus close to the vest, but what about the overall study design and the size just so we can have some visibility to the potential data disclosures? And is this a phase 1B or phase two, and I have a quick follow-up. Thank you.

Well, thanks for the question. We're obviously, from the last couple of calls, it should be obvious that we're excited about the therapeutic potential for BAFF/APRIL inhibition across a wide range of these B cell mediated autoimmune diseases.

As we mentioned on this call, we initiated a clinical study of aritinercept in one autoimmune disease, and we plan, obviously, as we said, to initiate another, in an autoimmune disease in the first half of 2026. At that time we'll disclose the indications for each study in the second quarter of 2026, so look for more from us then. I can't say whether we're going to get into trial design, etc. At that, up until that point, but more to come by the second quarter of 2026.

Great, that's super helpful. Thanks, Peter. And then just one on lupus kidneys, I guess, things have been going pretty well. I think, raising guidance twice last year is a great indication that there's still some growing demand and momentum here.

So, I guess, could you qualitatively just talk about what's going better than expected? Are patients staying on therapy longer? Are you adding more patients on commercial drugs than expected? Are you seeing a better mix of insurers? I guess what's the the main driver of this continued strong performance as we head into 2026?

While we don't give individual commercial metrics anymore, what I can tell you, thank you for the question, is we are seeing growth across patients. We are seeing very solid and continued adherence to the product and persistency, and even the mix of our business when looking at the average price per commercial patient per year, all continue to perform with a level of Consistency.

Again, why we've kind of steered to... if you look at the historical growth pattern of this product over the last three years, it's probably the best way to think about its growth pattern going forward. And if you do that, I think you'll see why we landed in the guidance range that we did.

Thank you. (Operator Instructions) Arthur Heath from HG Wainwright.

Hey, good morning, Peter and the team. Congrats on the quarter. So, I just, kind of follow-up with the last question. So giving the guidance for the 2026, I'm just curious, how much, the growth is coming from the rheumatologist, versus the nephrologist? and given we have the guidance, the new guide ACR guidance, in hand for a while, do you believe we have reached a steady state of the guidance-driven prescribing, or it's still too early, like for the tails?

So let me break that question just in half. The first half was, are we seeing any break in terms of the trends on rheumatology prescribers as it relates to total revenue contribution versus nephrology?

The answer to that is slightly. One of the things that is key to our mid to longer-term strategy. Is to get earlier diagnosis and earlier treatment, which, by the way, I don't think is unique to Aurinia. I think, for the patients, for physicians, and for the future of this disease, we're strong believers that earlier treatment with drugs like LUPKYNIS are only going to have a short and longer-term patient benefit and probably save more kidneys and more patients extend more patients' lives over time.

So, rheumatology is key to that since these patients are SLE patients before they ever become diagnosed as lupus nephritis and catching them early and getting more aggressive treatment is going to start in the rheumatologist's office.

What I can tell you, because we aren't giving these specific metrics anymore, is we continue, see more prescribers in the rheum space, and while the business is pretty evenly broken between rheumatology and nephrology, it does favor the rheumatologists slightly, and that has been increasing over the last two years.

The second part of your question was centered on, why am I blanking now. Can you repeat it for me?

Yeah, I said like, which inning for the coming from the ACR guidance the policy impact to the prescribing.

Well. I think it's, for me, it's I'd ask Greg to jump in here too if I miss anything. The guidelines emphasize earlier diagnosis, and we know there's a long way to go here. They recommend that every time a lupus patient comes in that they get a urine analysis and look for proteinuria, as well as other indicators of the disease progression when they visit. What we do know is that doesn't happen.

Every time they visit, and as a matter of fact, it probably happens less than 50% of the time that a patient visits an office. So, if we can see that increase, we believe more proteinuria will be identified when more proteinuria is identified, if, and this is the second part, it's identified, we see aggressive treatment.

The guidelines say when you hit a certain target treatment level, that the patient should then be treated. We also know from payer data and database data that's out there that that doesn't happen either. So, more aggressive diagnosis, more aggressive treat to specific target of proteinuria.

Lastly, Target of keeping a patient on drug for three to five years, is clearly written in the guidelines, and we know that not just for LUPKYNIS, but for all drugs included, treating this more like a chronic progressive disease than an acute flare up within the disease, would all be a major progression for the treatment of the disease.

Yeah, no, I just agree with all those points. I think as clinicians become increasingly comfortable, confident in the new agents to include the LUPKYNIS that are more consistently treating for longer periods of time. And so that's something we look forward to continuing to support in the rheumatology and nephrology communities.

Thanks, guys. Maybe just a quick one for Greg. So, speaking of the retainer sector, Greg, could you remind us, how's the ADA situation for the, for your drug, when you see in the health form here?

Right. We mentioned in one of the previous calls that we have seen anti-drug antibodies at low titers, at doses, from 25 mg and above. At this point, as I noted, previously, we didn't see any impact on association with injection site reactions or changes in the pharmacokinetic or pharmacodynamic profile of those with positive ADAs relative to those that have not.

I'll just remind that's, each, ADA assay is bespoke antibody. It's not uncommon for drugs to have ADA levels, and we're quite confident as we go into subsequent work in our clinical trial program, that we'll be able to understand more of the impact of these things. At this point, we're very encouraged with, what we see and our confidence is high in this molecule.

Thank you. (Operator Instructions) Sahil Dhingra from RBC

Hi, this is Sahil Dhingra. Thank you so much for taking your questions. My question is related to the competitive landscape. We have seen that Gazyva was recently approved in, the LN indication.

First question is, have you seen any impact of the positioning of LUPKYNIS in the treatment landscape following that launch? And related question is that, is the approval of Gazyva incorporated in your guidance and how do you think it will impact LUPKYNIS going forward? Thank you.

Well, your first question about near term impact from the launch, our answer would be no. We continue to, see the business performing consistently as it has historically. The question of how it will perform on a go forward and represented our guidance? I think our guidance represents a lot of factors including, new competition and progression of implementation of the guidelines and a multitude of different factors as it relates to Gazyva We actually and all new potential competitors.

As I mentioned earlier, I do think there's major room that can be made, improvement that can be made both in awareness building at the patient level. Awareness building on the treatment guidelines and diagnostic guidelines for the treatment of lupus nephritis, identification and more aggressive treatment of the disease, and all of these things will grow the market significantly before you ever get into the question of what's the better treatment option.

And there we believe we have an incredibly competitive profile because the guidelines emphasize rapid reduction in proteinuria as early as three to six months. I would challenge those on the call to go back, and all these drugs stand on their own merits and will be used by physicians based upon the labels that they get. But if you look closely at the data in terms of rapid improvement and reduction in proteinuria.

Generally speaking, the novel competitors that we're seeing in the marketplace appear to not have the ability to reduce proteinuria levels to target treatment guideline levels as quickly as what we've seen with LUPKYNIS. Greg, what would you add?

Just to put a punctuation on that point, in our pivotal trial, we saw a 50% reduction in proteinuria within one month's time from initiation of LUPKYNIS in those that were studied. We know that for hitting the primary endpoint, our study was designed to show the benefits at 12 months, that goals were achieved, for the most part by six months' time.

I'll remind you that with Gazyva, the primary endpoint is at week 76, and it took that long to be able to get important clinical responses, complete renal response. It took a year and a half, so the speed with which it works is notable. I'll Also emphasize relative to Peter's point, Gazyva and B-cell targeted agents are one axis of the immune system.

LUPKYNIS is the only indicated treatment for LN that targets the T cell and also has a podocyte protection effect. These are complementary mechanisms of action. The speed with which LUPKYNIS works is notable, and to Peter's point, the awareness with regard to aggressive treatment that will be created by additional important agents in this area will just improve the likelihood of getting better patient outcomes.

Great, this is very helpful. Thank you so much for taking my questions.

Thank you.

Thank you.

(Operator Instructions) David Martin from Bloom Burton. Your line is now live.

Good morning and congratulations on the quarter.

I realized Lukinis was launched in the US market first. Do you expect the other global markets will catch up to the US as far as penetration in the lupus nephritis patient population?

While I can't speak directly for Otsuka, our partner in Europe and in Japan, I can, give you what we hear through them and what we understand about the market, and I think the short answer there, David, is no. Every country has individual pricing and reimbursement and guidelines as to how They implement the global guidelines for the treatment of the disease. Pricing in every market is different and historically has been lower than what we've seen in the US and North America. So at least from our expectations standpoint and contribution to this company, as we've said historically, we don't see it as a major contributor for our balance of the overall Luke Kiis business. Now that being said, it has been every year, a good contributor to our growth and sustaining of the business just on a relative basis. It's not a large percentage, and we don't expect that it's going to see the same type of aggressive treatment, pricing, and or reimbursement that we see in the United States.

Okay, thanks. And second question, I, are docs, are you finding, are they combining BNT cell therapies or choosing one or the other?

I think it's a really good question and one that you know we plan to continue to think about and potentially explore moving forward and I welcome Greg's comments here, but just one intro. If you think about it, there's a rationale to potentially combine B cell and more T cell mediated therapies that could potentially even reduce. Proteinuria faster, but faster and or more effectively. But in addition, what we see probably in the market more often is that, lupus patients more are being initiated or looked at as potential candidates for B cell, novel B cell therapies earlier in the treatment. Paradigm and what needs to be considered as a lupus patient when they have controlled symptoms of their lupus, i.e., maybe fatigue or skin condition or tender and aching joints. If those are controlled, yet they have a breakthrough of proteinuria, we often get the question of how to initiate a drug like leukinus. If they're already on a B cell and they don't want to take them off of that B cell. So, point being, there are two reasons to potentially address this. One is to more effectively manage lupus nephritis. The other is, would you, could you not stop one therapy to continue another, and is there a safe and efficacious reason for that? And we are, Seeing it and we are discussing and planning internally to potentially look at how we might address this through research and development work in the combination of the two. Greg.

Yeah, and so thanks, Peter. And the only thing I'd add, because it is logical to consider combining these, I'll point out that the targeted approach of specific B cell and T cell.

Related targeting makes logical sense relative to non-specific immunosuppression. Think of MMF and higher doses of glucocorticoids. So an additional question we get is what's the possibility of reducing some of those other non-specific agents. So relative to your question, the science. The academics in the field are very much posing this as a logical way to do much more targeted efficient treatment of patients with lupus in general, but for lupus supress specifically. So more work to be done there. It's a logical question, and we intend to think about that a lot more in the upcoming months.

Thank you.

(Operator Instructions) Olivia Breyer from Cantor Fitzgerald. Your line is now live.

Hey, good morning, guys. Thank you for the question. On, our Intercept, what's the cadence of updates that we should expect from that program? I mean, it sounds like next quarter we get some more meat on the bone, but beyond that, when can we start to expect to see more meaningful updates and data behind the program? And then given that you are looking at two indications, is there one that you maybe have higher conviction in or feel like Your your program has a better chance in.

Thanks for the question, Olivia. So I would expect to hear more in second quarter 2026. I'll kind of leave it at that, because we're not giving any future view as to what we're going to disclose or not disclose for that matter, and I would say we don't have a preferential indication in mind in terms of probability for success or one we feel more committed to.

I will say what we're excited about the most here is the fact that this looks like not just from our work but from the work of everyone working on both BAFF/APRIL combination or combination or straight BAFF or straight April that these products can address a multitude of different autoimmune diseases and inflammatory conditions.

That's probably what we're the most excited about and we're trying to take a very thoughtful, methodical approach to where we start, where we create a beachhead, and if we're successful there, we think there's great opportunity to potential build that potentially build from there. I think that's been proven by those who are doing work here as well. So more to come, a little bit of a non-answer. I apologize for that, but, not, it's not because we don't want to talk more about the details of our plan. We just want to be purposeful about how we roll it out.

Okay, understood. And then I'll follow-up on Gazyva. What are you guys hearing in terms of what Roche is doing to grow that market, and what's maybe been the initial feedback from physicians just around how they're thinking about sequencing therapies now that there are multiple options available?

Surprisingly, it's been a little bit quiet. I mean, much like Benlysta, the focus appears to be on the larger piece of the population. For context purposes, you've got an SLE population that's, hundreds of thousands of patients in the U.S., and an LN population, which is a subset of that SLE population, that's probably tens of thousands of patients.

If you think about it strategically and from a positioning standpoint, and I think as many. Are aware Gazyva has also produced their data in lupus, and it looks like they'll have a good regulatory pathway in lupus as well. You'd probably want to position these products further upstream for earlier treatment in lupus with the potential to, and not that they've done research this way, avoid kidney complications down the road.

We know that's how Benlysta is currently positioned in the marketplace, and I would think it's highly likely that Gazyva is going to be positioned there as well. We don't have any specifics on marketing materials or how they're positioning it, and lupus nephritis specifically.

But Greg did give a good articulation earlier of. Where we see the competitive profile here and we honestly and truly do believe that a rising tide lifts all boats here. More patients getting identified with nephritis, more patients getting aggressively treated with lupus, awareness building, treatment guideline adoption, all grow this market for patients and for the drugs that are trying to be utilized here for those patients.

Thank you. We've reached the end of our question-and-answer session. I'd like to turn the floor back over for any further closing comments.

No, I want to thank everybody for joining us on the call today. We look forward to further updates in the future and have a great day.

Thank you. That does conclude today's teleconference and webcast. You may just connect your line at this time and have a wonderful day. We thank you for your participation today.