Aurinia Pharmaceuticals Inc. (AUPH) Q2 2025 Earnings Report, Transcript and Summary

Greetings, and welcome to the Aurinia Pharmaceuticals Second Quarter 2025 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Joe Miller, Chief Financial Officer for Aurinia. Thank you. You may begin.

Thank you, operator, and thank you, 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; and Dr. Greg Keenan, Aurinia's Chief Medical Officer. Today, we will review and discuss Aurinia's second 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 U.S. 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 a discussion of factors that could affect Aurinia's future financial results and business, please refer to the disclosures in Aurinia's press release, quarterly report on Form 10-Q and all other filings with the U.S. Securities and Exchange Commission and Canadian securities authorities. Please note that all statements made during today's call are current as of today, July 31, 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 statements. Now let me turn the call over to Aurinia's President and CEO, Peter Greenleaf. Peter?

Thanks, Joe, 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 second quarter results and provide an update on all corporate initiatives. I'll then turn the call back over to Joe to provide additional detail on our financial results. We continue to achieve strong growth in total revenue and net product sales in the 3 and 6 months ended June 30, 2025. For the 3 and 6 months ended June 30, 2025, total revenue was $70 million and $132.5 million, up 22% and 23%, respectively, from $57.2 million and $107.5 million, respectively, in the same periods of 2024. For the 3 and 6 months ended June 30, 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 $66.6 million and $126.5 million, up 21% and 23%, respectively, from $55 million and $103.1 million in the same periods of 2024. The increase for both periods is primarily due to an increase in the number of LUPKYNIS cartons sold to specialty pharmacies, driven by further LN market penetration. For the 6 months ended June 30, 2025, cash flow generated from operations was $45.5 million. This is compared to a negative $2.8 million in cash flow used in operations in the same period of 2024. Excluding $11.5 million in cash payments made in 2025 in connection with the November 2024 restructuring, cash flow generated from operations was $57 million for the 6 months ended June 30, 2025. As of June 30, 2025, we have cash, cash equivalents, restricted cash and investments of $315.1 million. This is compared to $358.5 million at December 31, 2024. For the 6 months ended June 30, 2025, the company repurchased $11.2 million of its common shares for $90.8 million, including commissions and excise tax. As a result of the sustained growth we've seen in the first half of 2025, we are increasing our full year 2025 total revenue guidance from a range of $250 million to $260 million to a range of $260 million to $270 million and our net product sales guidance from a range of $240 million to $250 million to a range of $250 million to $260 million. Finally, we reported positive results from our aritinercept Phase I single ascending dose study on June 30, 2025. Aritinercept is a dual BAFF APRIL inhibitor. It contains a BCMA engineered extracellular binding domain that's optimized for superior affinity to APRIL and BAFF. We remain on track to initiate further clinical studies for aritinercept in at least 2 autoimmune diseases in the second half of this year. We are very excited about the wide range of therapeutic possibilities for aritinercept, but for competitive reasons, we will not be disclosing further detail about our future plans at this time. I'd now like to turn the call back over to Joe for a more detailed review of the second quarter 2025 financial results. I'll then return at the end of the call for a quick recap and to open up the line for any questions you might have. Joe?

Thank you, Peter. Let's take a few minutes to discuss the second quarter 2025 financial results. For the 3 and 6 months ended June 30, 2025, total revenue was $70 million and $132.5 million, up 22% and 23%, respectively, from $57.2 million and $107.5 million in the comparable periods of 2024. As Peter mentioned, we had cash, cash equivalents, restricted cash and investments of $315.1 million as of June 30, 2025, and generated cash flows from operations of $45.5 million compared to $2.8 million in cash flow used in operations in the same period of 2024. Excluding $11.5 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $57 million for the 6 months ended June 30, 2025. We are continuing to be opportunistic with our share repurchase plan and expect to fund any future discretionary share repurchases with cash flows from operations and cash currently on hand. The company repurchased 18.3 million of its common shares for $138.4 million, excluding commissions and excise tax since the launch of the program in the first quarter of 2024 through today. Additionally, today, we announced that the Board has approved an increase to the share repurchase plan of up to an additional $150 million of common shares over the initially approved $150 million Board authorization. For the 3 and 6 months ended June 30, 2025, cost of revenue was $7.1 million and $15.7 million, respectively, compared to $8.9 million and $16.7 million in the comparable periods in 2024. The decrease for both periods is primarily due to a decrease in sales of LUPKYNIS inventory to Otsuka, which is sold under a cost- plus arrangement and has a lower gross margin than our other LUPKYNIS sales. For the 3 and 6 months ended June 30, 2025, gross margin was 90% and 88%, respectively, compared to 84% and 85% in the same periods in 2024. For the 3 and 6 months ended June 30, 2025, total operating expenses were $49.9 million and $90.5 million, respectively, compared to $58.7 million and $122.3 million in the comparable periods of 2024. The decrease for both periods is primarily due to lower personnel expenses, including share-based compensation and overhead costs as a result of our strategic restructuring efforts in 2024. This was partially offset by an increase in R&D-related expenses as we continue to advance our development activities for aritinercept and voclosporin and other noncash expenses related to the remeasurement of our Swiss franc-denominated monoplant finance lease liability and changes in our fair value assumptions related to our deferred compensation liability. For the 3 months ended June 30, 2025, net income was $21.5 million or $0.16 of earnings per share compared to $722,000 or $0.01 of earnings per share in the same period of 2024. For the 6 months ended June 30, 2025, net income was $44.9 million or $0.33 of earnings per share compared to a net loss of $10 million or $0.07 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. Peter?

Thanks, Joe. In summary, we continue to drive growth in the commercial LUPKYNIS business, move forward with the clinical development of aritinercept and maintain excellent operational efficiency. I want to thank you all for your time today. We'll now open the lines for any questions you may have. Operator?

[Operator Instructions] Our first question comes from the line of Stacy Ku with TD Cowen.

This is Vish on for Stacy. Congrats on a great quarter. So you reported some encouraging data for aritinercept. And I understand that you're not for competitive reasons, disclosing any details, but could you at least guide us through how you're thinking about the potential for aritinercept? Where do you think it could generate or add the most value so that us and investors could appreciate how you're thinking about the development? And based on the PK/PD data from the SAD study, how are you thinking about maybe potentially doses to be moved forward for the POC studies? And I have one follow-up.

Yes. I mean I'll start, and I'll ask Greg to jump in where I might miss or where he sees some add-on here. Listen, I think the potential of these B-cell mediated diseases and APRIL/BAFS potential ability to affect these B cell-mediated diseases is apparent today, obviously, in the data that's been rolled out in areas like IgAN. But we, as a company, have done our own assessment internally. We think there's upwards of 20 to north of 20 different B-cell-mediated diseases that you could look at potentially for these compounds. So while we're not disclosing exactly where we're going in our exact approach for competitive reasons at this stage, know that we see a pretty wide open field in terms of other areas that could potentially be addressed even outside of the kidney indications that have been explored to date. So we'll look forward to talking more about that in the future. But at this point, as we've said, we're not disclosing for competitive purposes, but no, we're looking at a range of indications. Greg, do you want to talk maybe a little bit about the dose side of the single ascending dose study?

Sure. Thank you, Peter. Yes, based on the evidence from the single ascending dose study, we're very confident now that a Q4-week dosing schedule is justified with evidence, especially with regard to kinetics, the pharmacokinetics and the pharmacodynamics of -- that we've demonstrated with the single ascending dose. So we think Q4-week dosing will be something we can explore and confidently be able to demonstrate some important evidence as we move forward into the multiple ascending dose studies.

Got it. And then my follow-up was on LUPKYNIS. Actually, clearly, the sales are doing well and you're raising guidance. So can you just detail some effects that you are seeing of the updated ACR guidelines on LUPKYNIS adoption? Maybe discuss how rheumatology versus nephrology prescribing is going and what that looks like right now?

Yes. I think we're encouraged by the guidelines. And I think two evidence points, I guess, I would give you that the guidelines are having some impact, albeit they're not quantitative, they'll give you a directional feel for how they're impacting our business. We've seen a really strong uptick in the number of rheumatology prescribers. The guidelines themselves alongside of -- we've got the 2-year extension of the original AURORA study that's been out there. We had the biopsy substudy that was published in a rheumatology journal. I think that, in combination with the guidelines has driven higher prescribing that we're seeing in rheumatology offices, so an increase there. And then in addition, we're seeing an increase in our hospital business. And I think that's a direct reflection of the academic setting and fellows and teaching institutions adopting those guidelines and using them more proactively. So while it's not a quantitative answer, it can give you a really good feel for how we think they're impacting. Rheumatologists are using more of our drug. They're growing at a faster rate than nephrologists right now. And then in addition, our hospital business has been growing in a healthy way since the guidelines have been published.

Our next question comes from the line of Maury Raycroft with Jefferies. James Alexander Stewart Vane-Tempest This is James on for Maury. Congrats on the progress. Just another question on LUPKYNIS and then I have a follow-up question. For the raised guidance, can you talk more about the drivers and what you're seeing from new patient starts and hospital restarts trends in the initial 4 weeks in 3Q and learnings from prior summer months that informs your commercial outlook for 2025?

Yes. I want to start and then Joe, if I miss anything, please jump in. So I think the best way to think about our guidance range is on the lower end to the midpoint of our revised guidance, you'd have to see either a flattening of our business or a declining of our business in the summer months and back to growth in the back half of the year. The higher end of our guidance range is continued growth through 3Q and 4Q. If you look historically, James, at how our sales have progressed. And as we've said on previous calls, we now think history is probably the best way to predict how this business moves forward. The summer months have -- we've seen a slowing in some of our metrics. In particular, the PSFs have been a little lighter historically in the summer months. And our revenue has been relatively flat to the previous quarter, so flat to 2Q using history. So the way we're looking at our guidance range is the low to mid you see the historical trends, high to beat above is we keep growing quarter-on-quarter. And we're really encouraged by everything we're seeing in the business right now. So we're excited to take up the guidance range, and that's kind of how we're thinking about it, James. James Alexander Stewart Vane-Tempest Got it. And then a second one for your BAFF/APRIL inhibitor aritinercept. Can you talk more about when we can see the next data update from the MAD phase and more on rare/orphan autoimmune diseases that you aim to pursue. What are the gating factors to picking specific disease settings to pursue? Are you waiting for competitor updates? Or is it more related to evolving internal strategy?

Well, I mean, I wouldn't assume that we're waiting, and I wouldn't assume that we're ruminating on any of this. I would say -- I would assume we're moving forward. We're just not communicating externally for public reasons exactly what our approach is going to be or the timing of those programs. As we've said, we want to go after at least two B-cell-mediated diseases. We're going to get those enrolling by this year, by the end of this year. And we'll look forward in the future to talking more about it. But at this stage, that's all we're giving, James.

Our next question comes from the line of Joseph Schwartz with Leerink Partners.

This is Will on for Joe. Congrats on the progress this quarter. So I just have one on the B-cell program and then a quick follow-up. So on the prior data call, you had mentioned that you were doing some formulation work for AUR200. Is this work still ongoing? Or is it going to be completed prior to the initiation of these future studies later this year? And can you just help us understand the point of this formulation work? Is it specifically to do an auto-injector? Or what's the ultimate goal here? And I have a quick follow-up.

Yes. As we said on our previous call, Will, our goal would be to try to get it in the most patient-friendly potential formulation and device possible, and that could include an auto-injector. And we actually think looking at the doses we've seen to date, the molecular size that we have -- we could have the possibility to do that. But obviously, once you're in single ascending dose studies, you're not optimized towards -- or at least we haven't to those formulations yet. And that's -- it's parallel pathing with the development work that we're doing. But everything points to us being able to -- from what we've seen in the single ascending dose and in the preclinical work that we've done up to this point that those goals would be attainable.

Great. And then just quickly, a question for Joe. As we see the development of AUR200 ramp up, how should we be thinking about R&D spend moving forward? And can you help us put some brackets or kind of general commentary around the cost for these trials? And do you expect to remain cash flow positive during the development of this asset?

Thanks for the question, Will. We haven't provided any specific guidance on operating expenses and/or cash flows going forward. Obviously, as we are moving through 2025, the trial costs were fairly manageable, and you would expect as you kind of move from Phase I and II and on that the costs will increase. But as of right now, we're not giving any specific long-term guidance on OpEx, R&D expenses and/or cash flows.

Yes. I think that's right, Joe. And the only thing I would say is it should be evident to investors that efficient operations and cash flow from operations, however we decide to deploy it is a priority for us as an organization. So that won't change on a go-forward basis.

Our next question comes from the line of Arthur He with H.C. Wainwright.

Congrats on the decent rise. I just had two questions regarding the 200. So Greg, do you guys plan to present the detail data at any medical conference from the SAD study?

Greg, maybe can talk to what our intentions are. I think you should just appreciate that, obviously, we have ongoing patent work, et cetera, with the compound. So what's publicly detailed, we would have that ability to do, but stuff that has not yet been publicly talked about, probably not. Greg, any intentions?

No, nothing more than that. It will be presented in an upcoming meeting, but we haven't determined which meeting at this point.

Okay. Got you. And the second question on the 200. So maybe, Peter, I just want to gauge like at what kind of situation or circumstance you guys would be -- feel comfortable to disclose the information about the details of indication going after for the 200. Just curious.

Well, I mean, the obvious answer is when we move into a certain phase of development, it becomes public information and available on clinicaltrials.gov. So that would be my absolute answer. We haven't really discussed it with our Board, Arthur, or we have, and we've deduced and concluded that for competitive purposes, obviously, we've got people that are ahead of us and behind us, and we want to hold what we're doing close to the vest and ensure that we don't lead people down the path of exactly what we're doing. We haven't determined yet when we would disclose. But do realize from the line of questioning here and on our previous call, that there is a lot of appetite to understand what our plans are.

Our next question comes from the line of Doug Miehm with RBC Capital Markets.

Just with respect to Paragraph IV filers, there's no change there. No change as it stands right now in terms of the exclusivity period and adding pediatric onto that. Any updates?

No. And just to clarify that the pediatric trial work that we're doing was part of the original filing, but was not an extension body of work. So the July 2028 worst-case scenario is not inclusive of 6 months of pediatric exclusivity, Doug. No, no changes. We still have patents going all the way out to 2037. We still have our method of use patents, and we continue to do more work around both patents and other work in the company to ensure the longevity of LUPKYNIS. I would just reinforce that the longevity of this asset to us is paramount and it comes to defending the IP that we have around the compound, and it's a priority for the company. So we'll update you when we have more to talk about. But as you know, the legal process on ANDA filings and the subsequent patent infringement lawsuits is pretty protracted. So I wouldn't expect to hear weekly updates from us.

Okay. Second question just has to do with the buyback, and you're aggressive there. There's an obvious opportunity today. As we think about the future, though, given the amount that you're likely to spend on the R&D side being it's going to increase probably fairly materially, will we think that we could see scaled back buybacks as we think about beyond 2025? I'll leave it there.

Doug, as we've said, it's up to the Board's discretion and as to how they deploy that cash. Obviously, management gives input to our belief as to what we should do. I wouldn't miss that LUPKYNIS continues to grow for us. And the cash flows we reported in this quarter, if you carry those forward and you carry forward continued growth of LUPKYNIS, the amount of cash flow from operations is -- becomes fairly significant. Now we're not giving long-term or even mid- to short-term guidance on cash flows, but you can do the math. And I think it gives us a very unique position as a biotech company in this space to pay our bills. We have cash on our balance sheet. We have cash flows from operations, so we can pay for the things we want to do, continuing to drive LUPKYNIS and developing our pipeline and we have the unique ability to either collect cash -- more cash on our balance sheet and grow that over time or deploy it towards buying back shares, which is positive for all shareholders. So while we're not giving anything for '26, and I don't disagree that, obviously, your R&D expenses go up as you move into further clinical trials, don't miss the fact that if LUPKYNIS, which we fully believe will continue to grow, grows, our cash flow from operations and our balance sheet are still very, very strong.

Thank you and this concludes we have reached the end of the question-and-answer session. And this also concludes today's conference, and you may disconnect your lines at this time. We thank you for your participation, and have a great day.