Greetings, and welcome to the Aurinia Pharmaceuticals Inc. Q1 2025 Earnings Call. At this time, all participants are in a listen-only mode. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Andrea Christopher, Corporate Communications and Investor Relations. Please go ahead, Andrea.

Thank you, operator, and thank you to everyone for joining today's call and webcast. Joining me on the call this morning are Peter Greenleaf, Aurinia’s President and Chief Executive Officer; Joe Miller, Aurinia’s Chief Financial Officer; and Dr. Greg Keenan, Aurinia’s Chief Medical Officer. Today, we will review and discuss Aurinia’s first quarter 2025 financial results and provide an update on recent corporate progress as communicated in the company's press release and quarterly report on Form 10-Q issued this morning. For more information, please refer to Aurinia's filings with the US Securities and Exchange Commission and Canadian securities authorities, which are also available on Aurinia's website at auriniapharma.com. During today's call, Aurinia 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. For discussion of factors that could affect Aurinia's future financial results in business, please refer to the disclosures in Aurinia’s press release, quarterly report on Form 10-Q, and all other filings with the US Securities and Exchange Commission and Canadian securities authorities. Please note that all statements made during today's call are current as of today, May 12, 2025, unless otherwise noted, and are based upon information currently available to us. Except as required by law, Aurinia assumes no obligation to update any such statement. Now let me turn the call over to Aurinia's President and CEO, Peter Greenleaf. Peter?

Thanks, Andrea, and good morning, everyone. I want to thank everybody for joining us today. On this morning's call, I'll provide an update on our first quarter 2025 results and provide an update on recent progress. I'll then turn the call over to Joe Miller, our CFO, to provide additional details on our financial results. With a continued focus on commercial execution and driving operational efficiency, we achieved strong growth in total revenue and net product sales in the first quarter. For the first quarter of 2025, total revenue was $62.5 million, up 24% from $50.3 million in the same period of 2024. For the first quarter of 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis or LN, were $60 million, up 25% from $48.1 million in the same period of 2024. The increase is primarily due to an increase in the number of LUPKYNIS cartons sold to specialty pharmacies and driven by further lupus nephritis penetration. For the three months ended March 31, 2025, cash flow generated from operations was $1.3 million, compared to a negative $18.6 million in cash flow used in operations in the same period of 2024. Excluding $11.1 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12.4 million for the three months ended March 31, 2025. Exiting the quarter, we have cash, cash equivalents, restricted cash and investments of $312.9 million as compared to $358.5 million on December 31, 2024. For the three months ended March 31, 2025, the company repurchased 5.8 million of its common shares for $47.4 million. With our solid 25% increase in sales growth for LUPKYNIS in the first quarter, we are poised for continued success in 2025. Following the recent update of the American College of Rheumatology lupus nephritis treatment guidelines, which recommends the incorporation of drugs like LUPKYNIS into first-line therapy, our commercial organization is focused on educating rheumatologists about the benefits of initiating LUPKYNIS earlier in the treatment paradigm. We have started the year in a solid position with a highly efficient organization focused on LUPKYNIS growth and are, therefore, reiterating our total revenue guidance in the range of $250 million to $260 million and net product sales guidance in the range of $240 million to $250 million for 2025. Finally, we remain on track to report initial results from the Phase 1 study of our pipeline product, AUR200, a dual BAFF/APRIL inhibitor for the potential treatment of a range of autoimmune diseases later this quarter. I'd like to now turn the call over to Joe Miller, our CFO, for a more detailed review of our first quarter 2025 financial results. I'll then return at the end of the call for a quick recap and to open up the line to any questions you might have. Joe?

Thank you, Peter, and good morning, everyone. Let's take a few minutes to discuss the first quarter 2025 financial results. For the three months ended March 31, 2025, total revenue was $62.5 million compared to $50.3 million in the same period of 2024. As Peter mentioned, we had cash, cash equivalents, restricted cash, and investments of $312.9 million as of March 31, 2025, and generated cash flows from operations of $1.3 million. Excluding $11.1 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12.4 million for the three months ended March 31, 2025. We are continuing to be opportunistic with our share repurchase program and expect to fund any future discretionary share repurchases with cash flows from operations and cash currently on hand. The company repurchased 14.5 million of its common shares for $108.5 million since the launch of the program in the first quarter of 2024 through May 8, 2025. For the three months ended March 31, 2025, cost of revenue was $8.6 million compared to $7.8 million in the same period of 2024. The increase is primarily due to an increase in Aurinia's net sales of LUPKYNIS. For the three months ended March 31, 2025, gross margin was 86% compared to 85% in the same period of 2024. For the three months ended March 31, 2025, total operating expenses were $40.6 million compared to $63.6 million in the same period of 2024. The decrease is primarily due to lower personnel expenses, including share-based compensation and overhead costs as a result of our strategic restructuring efforts in 2024, coupled with a reduction in non-personnel R&D expenses as a result of ceasing development of the company's AUR300 development program and restructuring-related one-time charges in the first quarter of 2024 that did not recur in 2025. This was partially offset by an increase in R&D-related expenses as we continue to advance our AUR200 program and other non-cash expenses related to the remeasurement of our Swiss franc-denominated model plan finance lease liability and changes in our fair value assumptions related to our deferred compensation liability. For the three months ended March 31, 2025, net income was $23.3 million or $0.17 of earnings per share compared to a net loss of $10.7 million or $0.07 of net loss per share in the same period of 2024. With that, I'd like to hand the call back over to Peter for some closing remarks.

Thanks, Joe. In summary, we're continuing to lean into our highest growth drivers for the commercial LUPKYNIS business, continuing clinical development of AUR200 and maintaining excellent operational efficiency throughout the organization. I want to thank you all for your time today. We'll now open the lines for any questions you might have. Operator?

Our first question is coming from Stacy Ku from TD Cowen. Your line is now live.

Hey, good morning. Congrats on the solid quarter and thanks for taking our questions. First is on LUPKYNIS. Can you maybe just talk about the quarterly cadence as we think about Q1 sales and your guidance for the year? I understand you're not disclosing metrics, but if you're not willing to comment on the quarterly cadence, maybe talk about what's driving sales these days? Is it largely new patient adds? Or is it more of the additional restarts and hospital adds? That's the first question. And then the second question is on AUR200. Just as we near the Phase 1 single-ascending dose update, maybe talk about some base case scenarios on how you give an update on next steps. Just maybe curious if you could speak to some strategies to get to market faster, what type of regulatory pathway you think is feasible as we think about other anti-APRIL/BAFF agents? Thanks so much.

Thanks, Stacy. Let me start with the first one. On LUPKYNIS, obviously, we're guiding to a range of $240 million to $250 million. I think the best way to think about the quarterly gate is to go back and look at historicals. And I think that will help in terms of how this business has performed consistently quarter-on-quarter. And obviously, somewhere in the 2Q, 3Q range, we've historically seen some effect in the summer and then we've historically seen kind of a lift in rise into the back half of the year, and that's been pretty predictive for the last several years. In terms of mix and drivers, what I can tell you is the full complement is still driving the business, everything from new patient adds to persistency, time to getting patients on drug. All of those continue to show improvement for us, but that improvement I would look at holistically it's not any one key driver. I will tell you, lastly, that our goal is to continue to drive rheumatology, and we've actually seen some good improvements in terms of rheumatology prescribing, not that we're overly trying to favor one versus the other, but we think it's indicative of early diagnosis and early treatment when rheumatologists are taking the lead in treating these patients. So, a good quarter. I think our guidance range staying consistent gives you where we think we're going to fall out and I think that's about it. On the AUR200, not to give you nothing here, but we're between now and the end of June, we intend to report out the data, and I would just ask you to wait till then. And that will be our single-ascending dose data. And we'll give more steer on the program once we get there.

Thank you.

Thanks, Stacy.

Thank you. Next question is coming from Maury Raycroft from Jefferies. Your line is now live.

Hi, good morning, congratulations on the quarter and thank you for taking my questions. I have a question about guidance. Historically, the first quarter tends to be the lowest quarter, so I'm curious if you expect the second quarter to be in line with or lower than that. Additionally, what trends are you observing in the initial six weeks of the second quarter that may influence your outlook for the remainder of the year?

Yeah, I'm not sure. I'd have to go back. I don't think 1Q is usually our lowest quarter, I think somewhere between the 2Q, 3Q spread because it incorporates the summer, usually using history has been the lower. And then usually, historically, we've come back to a rise in 4Q. So in terms of our guidance range, I think we are using history probably more than anything to sort of project where we're going for the year. And that would include what we've seen historically as a soft summer only. We're only sort of 1Q through this into 2Q. So we've got some time ahead of us and look forward to reporting 2Q when we do that. In terms of drivers, I kind of already talked to that more. But I think if you look at last year and the year before, probably that's the best way to think about quartering the remainder of the year.

Got it. And just wanted to ask on the ANDA filers too. It seems like there's a good number of those challenging the validity of the 2037 dosing protocol patent. Wondering if you could just talk more about that and what the strategy and risks are there?

Well, I mean, I think we've commented on this historically. So there's really nothing new outside of the fact that we had filers initially come in with ANDAs. We've obviously filed patent infringement lawsuits against all of them, intend to vigorously defend the patents that we have and we'll keep you updated along the way. But obviously, you know that through that, it automatically puts these filers under a 30-month stay of execution. And I have to just see that process through, and we have continued work that we're doing in the organization to, I guess I would just leave it with the longevity of LUPKYNIS is a priority for the organization. So lens on deck and not just defending our patents but making sure that we're working hard towards keeping that revenue stream coming in and the drug being an important drug for us well into the future.

Understood. Okay. Thanks for taking my questions. I'll be back in the queue.

Thanks.

Thank you. Next question is coming from Joseph Schwartz from Leerink Partners. Your line is now live.

Great. Thanks very much. So, I just had a couple of questions on potential new federal government policies here and Aurinia's potential exposure to tariffs. So, could you, first of all, just help us understand where the IP is domiciled for LUPKYNIS? How you're importing any product from overseas, whether it's at COGS or transfer prices if you've got significant drug stockpiled in the US? And if you can grow supply within the US over time? And then how should we think about any exposure Aurinia has to potential legislation based on the amount of government reimbursement for LUPKYNIS? Thank you.

There's a lot to unpack, Joe. Let me start with the tariff situation. Our active pharmaceutical ingredient is produced in Switzerland, but we have several years' worth of product already in the U.S. Even if tariffs were to be implemented, they would impact just a small percentage of our overall product costs at the API level. All our packaging and finishing work is done in the U.S., so we anticipate minimal to no impact over the next few years. The future of those tariffs and their effect on our API is still uncertain. Like many others, we are working diligently to maximize our product availability in the U.S. Regarding transfer pricing, we’re monitoring developments closely. As a Canadian company operating in the U.S., transfer pricing is a crucial part of our economic model. I understand that changing this may require more than just executive action; it might need congressional intervention. We are attentive to market trends and any changes coming from the President's administration concerning transfer pricing for foreign companies here. Lastly, regarding the most recent executive order, it's difficult to predict its implications. It appears there's a directive stemming from an order by President Trump, but its final outcome remains uncertain. We're keeping a close eye on this situation, as the entire pharmaceutical and healthcare industries are impacted by government pricing policies. Our business revenue is fairly balanced between private and government payers, so this is an area of concern we are closely monitoring.

Very helpful. Thanks, Peter.

Thank you, Joe.

Thank you. Next question today is coming from Olivia Brayer from Cantor Fitzgerald. Your line is now live.

Hi, good morning. Thank you for the question. So, for AUR200, is there anything you can say just around how many patients we will see data from or how many dose levels you've studied in that SAD trial? And maybe just overall thoughts around what kind of dosing schedule you think you'll need to be competitive and whether at-home administration is important or not?

I believe those are important questions, and we are looking forward to sharing the SAD data by the end of June. We are excited to present our findings. In the context of proteinuric kidney diseases, particularly in the IgAN space, we have additional APRIL/BAFF studies ahead of us. We will have more insights to share in just a couple of weeks regarding our progress and findings.

Okay. Peter, can you share any details about data disclosure regarding whether you'll host a call and what level of detail we should expect for the next steps?

Yes, aside from our commitment to presenting the single-ascending dose data by the end of June, we are not providing guidance on the extent or additional data we will disclose. We need to evaluate the ongoing trial's data first. Then, we will discuss with our Board what we want to make public regarding the program and our future direction. We anticipate sharing more information between now and the end of June.

Okay. Thanks. Looking forward to that.

Thank you.

Thank you. Next question is coming from Sahil Dhingra from RBC Capital Markets. Your line is now live.

Hi, good morning. This is Sahil for Doug Miehm. Thank you for taking our questions. I have two. My first question is about the SG&A expense, which was around $20 million this quarter and slightly below our expectations. I'm curious if there was any one-time item included in that figure, and how we should anticipate the SG&A expense moving forward.

All right. So, the question is on SG&A. We don't give expense level guidance, but maybe Joe can give a little bit on the quarter and how to think about it as it relates to the year.

Yeah. Thank you for the question, Sahil. Yeah, we don't provide specific guidance on OpEx by function. What I will say is that following our restructuring in November, we are on track to achieve our previously announced cash-based OpEx savings of approximately $40 million. So, again, the cash flows reported today is a result of our strong sales performance and represents the early benefit of streamlining our operations. So, as you look to kind of our SG&A expense, there was a small true-up as it related to stock-based compensation that ran through there. You can see that in the footnotes as it relates to our equity-based footnote. But outside of that, there was nothing unusual embedded within that functional line.

Okay, thanks. Then my second question is on Roche’s Gazyva that is expected where PDUFA date is in October 2025. So how do you expect the evolution of the LN treatment market and what impact do you think will it have on LUPKYNIS adoption? Thank you.

Why don't I start and I have a rheumatologist here in the room with me. So, it would be good to get his perspective as well, that’s Dr. Keenan, Chief Medical Officer. So, listen, I'm excited to have more large pharmaceutical companies into the lupus nephritis and the lupus market to help us grow awareness. Obviously, these guidelines that are most recently issued by the ACR, and by EULAR, and by KDIGO, all call for much more aggressive diagnosis and early treatment of the disease. If that actually happens, we've got internal data to show that the market will grow. And the more companies we have educating on those guidelines, will help us, we believe, to expand the market. So that's number one. Number two, obviously, Gazyva has got some data. And we've seen it and obviously were filed. I think we feel pretty confident that their filing will most likely be reviewed and they have a high probability of getting approval. Not that we can predict that, not that we're the owners of the asset in those conversations with the agency, but we think it's likely. It is a B-cell pathway drug. Greg, do you want to give any comment on what we see in the data as it relates to the drug and how the guidelines are.

Thank you, Peter. So, first off, it's great news for individuals and clinicians that care for people with lupus nephritis. The data there is encouraging and certainly supplementing what Peter was saying. We believe that this B cell agent will have an important role. The guidelines that were just issued last year, find a place for BENLYSTA you can imagine the opportunity for obinutuzumab to fit in that Category II of B-cell agents. We think nonetheless, that LUPKYNIS with its strong evidence and the timeliness of benefit achieving goals therapeutic goals, some within one month and six months time, that it will have a role in helping patients and doctors meet their goals quickly, which is a key part of what the ACR guidelines emphasize. I'll point out that the ACR guidelines in print have just been released this month, and it's very specific and the role for CNIs like voclosporin is explicit, not just in Class III and IV, but also in V. And so we think that it's a good day for patients. LUPKYNIS is going to continue to have an important role in helping patients achieve their goals.

I believe it ultimately comes down to speed. While these products are being approved, if it takes two years to achieve the results we see at one year, and even at three and six months, the guidelines are calling for quick reductions in proteinuria. So far, these B-cell agents have not been able to provide the rapid response and reduction in proteinuria that the guidelines require. In other words, we believe we have a very competitive profile.

Great. Thank you so much.

Thank you. Next question is coming from David Martin from Bloom Burton. Your line is now live.

Good morning. Thanks for taking my questions. My understanding is that LUPKYNIS is quite difficult to manufacture. The fact that you now have ANDA filers, does that infer to you that they've solved the puzzle and should they be able to manufacture the drug matching LUPKYNIS at commercial scale?

We don't have any insight into that. As part of their ANDA package, they'll need to demonstrate that they can actually manufacture it. Our position on our process remains unchanged. Whether they can replicate it or find an alternative way to do it is yet to be determined. We haven't reviewed our actual filing package.

Okay. And next major events in the patent litigation. What kind of timing should we expect and what events are coming up?

I mean we've obviously, have filed patent infringement lawsuits. I don't think we intend to disclose major milestones in the IP patent defense space. We will report them when there are major things to update on. But now we are in the throes of litigation, and I think you can look at any analog product, small molecule product that is in the ANDA battle and use that as a way to predict what we're going to see going forward, but we don't intend to give timelines on legal proceedings.

Okay. And then one last question. What endpoints do you anticipate could differentiate AUR200 from other APRIL and BAFF inhibitors with the Phase 1 SAD results?

I think the Phase 1 SAD results are obviously going to give us the pharmacokinetics and the pharmacodynamics of the product. That's everything from half-life of the product, which could be directly juxtaposed against what the dose of the product could be, how often you have to give it. We're going to get hopefully a good idea, the range of doses and then the impact on biomarkers like IgG, IgA, IgM and all those things will give us and give the market a way to assess how the product looks versus others in the space. And alongside of a strategic development pathway from there, those will all be important to look at as we roll out this single-ascending dose data.

Okay. Thanks. That’s it for me.

Thank you.

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 or closing comments.

Well, I want to thank everybody for taking the time with us today. Happy belated Mother's Day, and we look forward to updating you as the quarters roll forward here. Thank you.

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