NASDAQ:AUPH Aurinia Pharmaceuticals Q1 2025 Earnings Report $7.59 +0.12 (+1.61%) Closing price 07/8/2025 04:00 PM EasternExtended Trading$7.62 +0.03 (+0.33%) As of 07/8/2025 07:02 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast Aurinia Pharmaceuticals EPS ResultsActual EPS$0.16Consensus EPS $0.08Beat/MissBeat by +$0.08One Year Ago EPSN/AAurinia Pharmaceuticals Revenue ResultsActual Revenue$62.47 millionExpected Revenue$61.06 millionBeat/MissBeat by +$1.41 millionYoY Revenue GrowthN/AAurinia Pharmaceuticals Announcement DetailsQuarterQ1 2025Date5/12/2025TimeBefore Market OpensConference Call DateMonday, May 12, 2025Conference Call Time8:30AM ETUpcoming EarningsAurinia Pharmaceuticals' Q2 2025 earnings is scheduled for Wednesday, July 30, 2025, with a conference call scheduled on Thursday, July 31, 2025 at 8:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)SEC FilingEarnings HistoryCompany ProfilePowered by Aurinia Pharmaceuticals Q1 2025 Earnings Call TranscriptProvided by QuartrMay 12, 2025 ShareLink copied to clipboard.Key Takeaways Total revenue reached $62.5M in Q1, up 24% year-over-year, while Lupkynis net product sales grew 25% to $60M. Generated $1.3M of cash flow from operations versus a $18.6M outflow last year, or $12.4M excluding restructuring payments. Operating expenses dropped to $40.6M from $63.6M in Q1 2024 due to strategic restructuring and reduced R&D spend. Reiterating 2025 guidance with total revenue of $250–260M and net product sales of $240–250M, reflecting confidence in growth trajectory. On track to report initial Phase 1 data for AUR200, a dual BAFF/APRIL inhibitor, later this quarter, informing next steps in the pipeline. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallAurinia Pharmaceuticals Q1 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Greetings, and welcome to the Aurinia Pharmaceuticals Inc. Q1 twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. Call. As a reminder, this conference is being recorded. Operator00:00:26It's now my pleasure to turn the call over to Andrea Christopher, Corporate Communications and Investor Relations. Please go ahead, Andrea. Andrea ChristopherHead of the Corporate Communications & Investor Relations at Aurinia Pharmaceuticals00:00:34Thank 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 Doctor. Greg Keenan, Aurinia's Chief Medical Officer. Today, we will review and discuss Aurinia's first quarter twenty twenty five 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. Andrea ChristopherHead of the Corporate Communications & Investor Relations at Aurinia Pharmaceuticals00:01:04S. Securities And Exchange Commission and Canadian Securities Authorities, which are also available on Aurinia's website at irinipharma.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. Andrea ChristopherHead of the Corporate Communications & Investor Relations at Aurinia Pharmaceuticals00:01:34S. Securities and Exchange Commission and Canadian Securities Authorities. Please note that all statements made during today's call are current as of today, 05/12/2025, 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 Greenlee. Peter? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:02:01Thanks, 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 twenty twenty five 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. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:02:32For the first quarter of twenty twenty five, total revenue was $62,500,000 up 24% from $50,300,000 in the same period of 2024. For the first quarter of twenty twenty five net product sales of Loop Kinus, the first FDA approved oral therapy for the treatment of adult patients with active lupus nephritis or LN were $60,000,000 up 25% from $48,100,000 in the same period of 2024. The increase is primarily due to an increase in the number of Leukinus cartons sold to specialty pharmacies and driven by further lupus nephritis penetration. For the three months ended 03/31/2025 cash flow generated from operations was $1,300,000 compared to a negative 18,600,000.0 in cash flow used in operations in the same period of 2024. Excluding $11,100,000 of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12,400,000 for the three months ended 03/31/2025. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:03:47Exiting the quarter, we have cash, cash equivalents, restricted cash and investments of $312,900,000 as compared to $358,500,000 in 12/31/2024. For the three months ended 03/31/2025 the company repurchased $5,800,000 of its common shares for $47,400,000 With our solid 25% increase in sales growth for Loop Kinus 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 loop kinase into first line therapy, our commercial organization is focused on educating rheumatologists about the benefits of initiating Loop Kinus earlier in the treatment paradigm. We have started the year in a solid position with a highly efficient organization focused on Loop Kinus growth and are therefore reiterating our total revenue guidance in the range of $250,000,000 to $260,000,000 and net product sales guidance in the range of $240,000,000 to $250,000,000 for 2025. Finally, we remain on track to report initial results from the Phase one study of our pipeline product AUR-two hundred, a dual BAP April inhibitor for the potential treatment of a range of autoimmune diseases later this quarter. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:05:21I'd like to now turn the call over to Joe Miller, our CFO for a more detailed review of our first quarter twenty twenty five 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? Joe MillerChief Financial Officer at Aurinia Pharmaceuticals00:05:38Thank you, Peter, and good morning, everyone. Let's take a few minutes to discuss the first quarter twenty twenty five financial results. For the three months ended 03/31/2025, total revenue was $62,500,000 compared to $50,300,000 in the same period of 2024. As Peter mentioned, we had cash, cash equivalents, restricted cash and investments of $312,900,000 as of 03/31/2025, and generated cash flows from operations of 1,300,000.0 Excluding $11,100,000 of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12,400,000 for the three months ended 03/31/2025. 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. Joe MillerChief Financial Officer at Aurinia Pharmaceuticals00:06:30The company repurchased $14,500,000 of its common shares for $108,500,000 since the launch of the program in the first quarter of twenty twenty four through 05/08/2025. For the three months ended 03/31/2025, cost of revenue was 8,600,000.0 compared to $7,800,000 in the same period of 2024. The increase is primarily due to an increase in Aurinia's net sales of loopkindness. For the three months ended 03/31/2025, gross margin was 86% compared to 85% in the same period of 2024. For the three months ended 03/31/2025, total operating expenses were $40,600,000 compared to $63,600,000 in the same period of 2024. Joe MillerChief Financial Officer at Aurinia Pharmaceuticals00:07:15The 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 and D expenses as a result of ceasing development of the company's AUR 300 development program and restructuring related onetime charges in the first quarter of twenty twenty four that did not recur in 2025. This was partially offset by an increase in R and D related expenses as we continue to advance our AUR 200 program and other noncash expense related to the remeasurement of our Swiss franc denominated monoplan finance lease liability and changes in our fair value assumptions related to our deferred compensation liability. For the three months ended 03/31/2025, net income was $23,300,000 or $0.17 of earnings per share compared to a net loss of $10,700,000 or $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. Peter? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:08:20Thanks, Joe. In summary, we're continuing to lean into our highest growth drivers for the commercial Lucanis business, continuing clinical development of AUR 200 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? Operator00:08:42Thank you. We'll now be conducting a question and answer session. Our first question is coming from Stacy Ku from TD Cowen. Your line is now live. Stacy KuAnalyst at Cowen00:09:08Hey, good morning. Congrats on the solid quarter and thanks for taking our questions. First is on lupinus. Can you maybe just talk about the quarterly cadence as we think about Q1 sales and your guidance for the year? 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. Stacy KuAnalyst at Cowen00:09:29Is 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 AUR 200. Just as we near the Phase one 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 BAF agents? Thanks so much. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:10:01Thanks, Stacy. Let me start with the first one. On Leukinus, obviously we're guiding to a range of 2.4 to $2.5 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 and 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. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:11:07It'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. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:11:44And I think that's about it. On the AUR 200, not to give you nothing here, but I think we're between now and the June, we intend to report out the data and I would just ask you to wait till then and that'll be our single ascending dose data and we'll give more steer on the program once we get there. Stacy KuAnalyst at Cowen00:12:10Thank you. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:12:12Thanks Stacy. Operator00:12:14Thank you. Next question is coming from Maury Raycroft from Jefferies. Your line is now live. Maury RaycroftEquity Research Analyst at Jefferies00:12:19Hi, good morning. Congrats on the quarter and thanks for taking my questions. I'll ask one just on guidance too. So for historically first quarter tends to be the lowest quarter. So just wondering if you're expecting second quarter to be in line or lower? Maury RaycroftEquity Research Analyst at Jefferies00:12:34And what are you seeing in the initial six weeks in second quarter that informs your the rest of your outlook for the rest of the year? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:12:42Yes, I'm not sure. I'd have to go back. I don't think 1Q is usually our lowest quarter. 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. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:13:13And that would include what we've seen historically as a soft summer. 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 Maury, 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. Maury RaycroftEquity Research Analyst at Jefferies00:13:41Got 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 02/1937 dosing protocol patent. Wondering if you just talk more about that and what the strategy and risks are there? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:14:01Well, I mean, I think we've commented on this historically. So there's really nothing new outside of the fact that we've 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 thirty month stay of execution and I'll just see that process through and we have continued work that we're doing in the organization to, I guess, would just leave it with the longevity of blue kinase is an A priority for the organization. It's all hands on deck, 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. Maury RaycroftEquity Research Analyst at Jefferies00:14:59Understood. Okay. Thanks for taking my questions. I'll hop back in the queue. Operator00:15:02Thanks. Thank you. Next question is coming from Joseph Schwartz from Leerink Partners. Your line is now live. Joseph SchwartzSenior Managing Director at Leerink Partners00:15:10Great. 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 in MFN. So could you, first of all, just help us understand where the IP is domiciled for leptokinase? 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 U. Joseph SchwartzSenior Managing Director at Leerink Partners00:15:44S, and if you can grow supply within The U. S. Over time? And then, how should we think about any exposure Aurinia has to potential MSN legislation based on the amount of government reimbursement for LUKINUS? Thank you. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:16:04There's a lot there, Joe. So let me just start with the tariff side of the equation, I guess. As you know, our API is done in Switzerland. But to be clear, we have several years worth of product that sits on U. S. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:16:22Soil. And I think that even if tariffs were depending on what the range of tariffs could be, it's on a very small percentage of our overall cost of goods at the API level. We do all our fillfinish work or our packaging work here in The U. S. So we think minimal to no impact over the next several years and then TBD as to what those tariffs would look like and what the impact would be on our API. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:16:55Of course, like most, we're working hard to ensure we have as much product in The U. S. As possible. And as I said, we've got several years here. In terms of transfer pricing, etcetera, we're watching this like everybody else. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:17:10Obviously, we're a Canadian company that does business in transfer pricing is part of how our economic model works. My understanding is it would take not an executive order but an act of Congress to actually go and impact that. So our ears are open and we're kind of watching where the market goes on this and where the President and his administration goes as it relates to not tariffs but the element of transfer pricing for ex U. S. Companies operating within The U. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:17:44S. And then lastly, the most recent executive order, your guess is as good as mine. It kind of seems like there is a directive put out there under an executive order by President Trump and then where it eventually lands, if it lands is kind of a TBD. So we're watching that as closely as you are because obviously the entire pharmaceutical and really healthcare industry is affected by the government pricing side of the business. To recall, our business is pretty evenly split between commercial pay, public pay, or excuse me, private pay the government side of the business. So obviously it's something we're watching closely. Joseph SchwartzSenior Managing Director at Leerink Partners00:18:28Very helpful. Thanks Peter. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:18:31Thank you, Joe. Operator00:18:33Thank you. Next question today is coming from Olivia Brayer from Cantor Fitzgerald. Your line is now live. Olivia BrayerAnalyst at Cantor Fitzgerald00:18:38Hi, good morning. Thank you for the question. So for AUR 200, is there anything you can say just around how many patients 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? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:19:02Yes, I think those are all good questions and we look forward to it's now almost mid May. And as we've said between now and the June, we're going to report out that SAD data. So we look forward to showing you what we've got. Obviously, in the areas of proteinuria kidney diseases and the like, there is more than one April bath ahead of us in the IGAN space. So we'll learn what we've got as it relates to others in just a short couple of weeks. Olivia BrayerAnalyst at Cantor Fitzgerald00:19:36Okay. Peter, anything you can say just around data disclosure in terms of how you guys are, will you host a call and kind of what level of details just in terms of next steps should we expect to see then? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:19:51Yes. I mean outside of the fact that we've committed to reporting out that single ascending dose data by the June, no, we're not giving any guide as to how much data and what will show in addition to that. So more to come. We got to discuss it. We got to see what the data is first because obviously this trial is ongoing and then we have to sit with our board and talk about what we want to disclose publicly as it relates to not just the program, but where we intend to go from there. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:20:23So we look forward to doing that, but it's between now and the June. Olivia BrayerAnalyst at Cantor Fitzgerald00:20:27Okay. Thanks. Looking forward to that. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:20:30Thank you. Operator00:20:33Thank you. Next question is coming from Sejal Dingra from RBC Capital Markets. Your line is now live. Sahil DhingraSenior Equity Research Associate - Healthcare at RBC Capital Markets00:20:39Hi, good morning. This is Sahil for Doug Me. Thank you so much for taking our questions. I have two. My first question is related to the SG and A expense. Sahil DhingraSenior Equity Research Associate - Healthcare at RBC Capital Markets00:20:48So that was around $20,000,000 this quarter and it was a bit below what we were we had modeled. So I wanted to know if there was any one time item in it? And how should we think about the SG and A expense going forward? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:21:03All right. So the question is on SG and A. We don't give expense level guide, but maybe Joe can give a little bit on the quarter and how to think about it as it relates to the year. Joe MillerChief Financial Officer at Aurinia Pharmaceuticals00:21:16Yes. Thank you for the question, Seal. Yes, 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 $40,000,000 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 and 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. Joe MillerChief Financial Officer at Aurinia Pharmaceuticals00:21:58But outside of that, there was nothing unusual embedded within that functional line. Sahil DhingraSenior Equity Research Associate - Healthcare at RBC Capital Markets00:22:06Okay. Then my second question is on Roche's GALCIVA that is expected where the PDUFA date is in October 2025. So how do you expect the evolution of the ELN treatment market? And what impact do you think will it have on leukotrienes adoption? Thank you. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:22:27Why 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 Doctor. Keenan, our 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 Cadaigo 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 GASVAIA has got some data and we've seen it and obviously we're filed. I think we feel pretty confident that their filing will most likely be reviewed and they have a high probability of getting approval. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:23:37Not 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 Greg KeenanChief Medical Officer at Aurinia Pharmaceuticals00:23:56you, Peter. So, first off, it's a great news for individuals and the 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 Benlystin. Greg KeenanChief Medical Officer at Aurinia Pharmaceuticals00:24:22You can imagine the opportunity for obinutuzumab to fit in that category to a B cell agents. We think nonetheless that gluconus with its strong evidence and the timeliness of benefit achieving both 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 three and four, but also in V. And so we think that it's a good day for patients. LUKOIS is going to continue to have an important role in helping patients achieve their goals. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:25:17Yes, think it comes to me comes down to speed. And while these products are obviously getting approved, if it takes two years to get the effect that we get at one year and quite frankly that we see it at three months and six months, the guidelines are calling for rapid reductions of proteinuria and these B cell agents so far have not been able to achieve the rapidity of response and reduction in proteinuria that the guidelines are calling for. So in other words, we think we have a very competitive profile. Greg KeenanChief Medical Officer at Aurinia Pharmaceuticals00:25:53Great. Thank you so much. Operator00:25:57Thank you. Next question is coming from David Martin from Bloom Burton. Your line is now live. David MartinManaging Director & Head of Equity Research at Bloom Burton & Co00:26:02Good morning. Thanks for taking my questions. My understanding is that Luke Kinus 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 with kind of sac commercial scale? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:26:24We don't have any insight into that outside of as part of their ANDA package, you'll have to show that they can actually manufacture it. So we haven't changed our position on what we believe our process is, whether they can duplicate it or find a way to do it differently is TBD. We haven't seen their actual filer package. David MartinManaging Director & Head of Equity Research at Bloom Burton & Co00:26:51Okay. And next major events in the patent litigation, what Operator00:26:58kind David MartinManaging Director & Head of Equity Research at Bloom Burton & Co00:26:58of timing should we expect and what events are coming up? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:27:03I mean, we obviously had to have filed patent infringement lawsuits. I don't think we intend to disclose major milestones in IP patent defense space. We'll 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 end of 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. David MartinManaging Director & Head of Equity Research at Bloom Burton & Co00:27:43Okay. And then one last question. What endpoints do you anticipate could differentiate AUR two hundred from other APRIL and BAF inhibitors with the Phase one SAD results? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:27:57I think the Phase one SAD results are obviously going to give us the pharmacokinetics and the pharmacodynamics of the product. That's everything from the 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 it 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. David MartinManaging Director & Head of Equity Research at Bloom Burton & Co00:28:46Okay, thanks. That's it for me. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:28:49Thank you. Thank Operator00:28:51you. We reached the end of our question and answer session. I'd to turn the floor back over for any further or closing comments. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:28:58Well, 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. Operator00:29:08Thank 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.Read moreParticipantsExecutivesAndrea ChristopherHead of the Corporate Communications & Investor RelationsPeter GreenleafPresident & Chief Executive OfficerJoe MillerChief Financial OfficerGreg KeenanChief Medical OfficerAnalystsStacy KuAnalyst at CowenMaury RaycroftEquity Research Analyst at JefferiesJoseph SchwartzSenior Managing Director at Leerink PartnersOlivia BrayerAnalyst at Cantor FitzgeraldSahil DhingraSenior Equity Research Associate - Healthcare at RBC Capital MarketsDavid MartinManaging Director & Head of Equity Research at Bloom Burton & CoPowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Aurinia Pharmaceuticals Earnings HeadlinesThe Play On Aurinia Pharmaceuticals: Rising Cash Flow Provides OpportunityJuly 7 at 1:12 PM | seekingalpha.comAurinia Pharmaceuticals (AUPH) Gets a Buy from TD CowenJuly 3, 2025 | theglobeandmail.comWhite House to reset Social Security?Elon Musk's parting DOGE gift looks set to shock America... A single announcement by July 22nd could soon bring Elon Musk's DOGE operation to its final, dramatic conclusion - with huge consequences for millions of investors. So if you have any money in the market... you're almost out of time to prepare. This plan has already been put in place... and can operate even if Elon's long gone from Washington. | Altimetry (Ad)Aurinia Pharmaceuticals Inc News (AUPH) - Investing.comJuly 3, 2025 | investing.comAUPH - Aurinia Pharmaceuticals Inc News - MorningstarJuly 2, 2025 | morningstar.comMAurinia Announces Positive Results from Phase 1 Study of Aritinercept (AUR200)June 30, 2025 | businesswire.comSee More Aurinia Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Aurinia Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Aurinia Pharmaceuticals and other key companies, straight to your email. Email Address About Aurinia PharmaceuticalsAurinia Pharmaceuticals (NASDAQ:AUPH). is a clinical‐stage biopharmaceutical company dedicated to developing and commercializing novel therapies for autoimmune and inflammatory diseases. Its flagship product, Lupkynis (voclosporin), is approved for the treatment of lupus nephritis, a severe kidney inflammation that arises from systemic lupus erythematosus. Aurinia’s research pipeline also encompasses investigational candidates targeting other immune‐mediated conditions, leveraging proprietary small‐molecule platform technologies to modulate key pathways involved in disease progression. Since its founding in 1993 and its relocation of global headquarters to Victoria, British Columbia, Aurinia has expanded its operational footprint with a strategic presence in the United States and Europe. The company collaborates with contract research organizations and clinical centers worldwide to advance its studies, ensuring robust patient enrollment and regulatory engagement across major markets. Aurinia’s manufacturing partnerships support scalable production of its lead therapy, while its commercial infrastructure continues to evolve as Lupkynis reaches new patient populations. Under the leadership of an experienced management team with deep expertise in biopharmaceutical development and commercialization, Aurinia is committed to achieving sustainable growth through disciplined clinical execution and strategic alliances. The company’s board of directors includes industry veterans from both large pharmaceutical companies and innovative biotech startups. Aurinia remains focused on delivering transformative treatments to patients with high unmet medical needs and on building long‐term shareholder value through scientific innovation and operational excellence.Written by Jeffrey Neal JohnsonView Aurinia Pharmaceuticals ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Smith & Wesson Stock Falls on Earnings Miss, Tariff WoesWhat to Expect From the Q2 Earnings Reporting CycleBroadcom Slides on Solid Earnings, AI Outlook Still StrongFive Below Pops on Strong Earnings, But Rally May StallRed Robin's Comeback: Q1 Earnings Spark Investor HopesOllie’s Q1 Earnings: The Good, the Bad, and What’s NextBroadcom Earnings Preview: AVGO Stock Near Record Highs Upcoming Earnings Bank of America (7/14/2025)America Movil (7/15/2025)Wells Fargo & Company (7/15/2025)Citigroup (7/15/2025)Charles Schwab (7/15/2025)Bank of New York Mellon (7/15/2025)Progressive (7/15/2025)JPMorgan Chase & Co. 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PresentationSkip to Participants Operator00:00:00Greetings, and welcome to the Aurinia Pharmaceuticals Inc. Q1 twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. Call. As a reminder, this conference is being recorded. Operator00:00:26It's now my pleasure to turn the call over to Andrea Christopher, Corporate Communications and Investor Relations. Please go ahead, Andrea. Andrea ChristopherHead of the Corporate Communications & Investor Relations at Aurinia Pharmaceuticals00:00:34Thank 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 Doctor. Greg Keenan, Aurinia's Chief Medical Officer. Today, we will review and discuss Aurinia's first quarter twenty twenty five 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. Andrea ChristopherHead of the Corporate Communications & Investor Relations at Aurinia Pharmaceuticals00:01:04S. Securities And Exchange Commission and Canadian Securities Authorities, which are also available on Aurinia's website at irinipharma.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. Andrea ChristopherHead of the Corporate Communications & Investor Relations at Aurinia Pharmaceuticals00:01:34S. Securities and Exchange Commission and Canadian Securities Authorities. Please note that all statements made during today's call are current as of today, 05/12/2025, 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 Greenlee. Peter? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:02:01Thanks, 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 twenty twenty five 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. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:02:32For the first quarter of twenty twenty five, total revenue was $62,500,000 up 24% from $50,300,000 in the same period of 2024. For the first quarter of twenty twenty five net product sales of Loop Kinus, the first FDA approved oral therapy for the treatment of adult patients with active lupus nephritis or LN were $60,000,000 up 25% from $48,100,000 in the same period of 2024. The increase is primarily due to an increase in the number of Leukinus cartons sold to specialty pharmacies and driven by further lupus nephritis penetration. For the three months ended 03/31/2025 cash flow generated from operations was $1,300,000 compared to a negative 18,600,000.0 in cash flow used in operations in the same period of 2024. Excluding $11,100,000 of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12,400,000 for the three months ended 03/31/2025. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:03:47Exiting the quarter, we have cash, cash equivalents, restricted cash and investments of $312,900,000 as compared to $358,500,000 in 12/31/2024. For the three months ended 03/31/2025 the company repurchased $5,800,000 of its common shares for $47,400,000 With our solid 25% increase in sales growth for Loop Kinus 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 loop kinase into first line therapy, our commercial organization is focused on educating rheumatologists about the benefits of initiating Loop Kinus earlier in the treatment paradigm. We have started the year in a solid position with a highly efficient organization focused on Loop Kinus growth and are therefore reiterating our total revenue guidance in the range of $250,000,000 to $260,000,000 and net product sales guidance in the range of $240,000,000 to $250,000,000 for 2025. Finally, we remain on track to report initial results from the Phase one study of our pipeline product AUR-two hundred, a dual BAP April inhibitor for the potential treatment of a range of autoimmune diseases later this quarter. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:05:21I'd like to now turn the call over to Joe Miller, our CFO for a more detailed review of our first quarter twenty twenty five 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? Joe MillerChief Financial Officer at Aurinia Pharmaceuticals00:05:38Thank you, Peter, and good morning, everyone. Let's take a few minutes to discuss the first quarter twenty twenty five financial results. For the three months ended 03/31/2025, total revenue was $62,500,000 compared to $50,300,000 in the same period of 2024. As Peter mentioned, we had cash, cash equivalents, restricted cash and investments of $312,900,000 as of 03/31/2025, and generated cash flows from operations of 1,300,000.0 Excluding $11,100,000 of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12,400,000 for the three months ended 03/31/2025. 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. Joe MillerChief Financial Officer at Aurinia Pharmaceuticals00:06:30The company repurchased $14,500,000 of its common shares for $108,500,000 since the launch of the program in the first quarter of twenty twenty four through 05/08/2025. For the three months ended 03/31/2025, cost of revenue was 8,600,000.0 compared to $7,800,000 in the same period of 2024. The increase is primarily due to an increase in Aurinia's net sales of loopkindness. For the three months ended 03/31/2025, gross margin was 86% compared to 85% in the same period of 2024. For the three months ended 03/31/2025, total operating expenses were $40,600,000 compared to $63,600,000 in the same period of 2024. Joe MillerChief Financial Officer at Aurinia Pharmaceuticals00:07:15The 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 and D expenses as a result of ceasing development of the company's AUR 300 development program and restructuring related onetime charges in the first quarter of twenty twenty four that did not recur in 2025. This was partially offset by an increase in R and D related expenses as we continue to advance our AUR 200 program and other noncash expense related to the remeasurement of our Swiss franc denominated monoplan finance lease liability and changes in our fair value assumptions related to our deferred compensation liability. For the three months ended 03/31/2025, net income was $23,300,000 or $0.17 of earnings per share compared to a net loss of $10,700,000 or $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. Peter? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:08:20Thanks, Joe. In summary, we're continuing to lean into our highest growth drivers for the commercial Lucanis business, continuing clinical development of AUR 200 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? Operator00:08:42Thank you. We'll now be conducting a question and answer session. Our first question is coming from Stacy Ku from TD Cowen. Your line is now live. Stacy KuAnalyst at Cowen00:09:08Hey, good morning. Congrats on the solid quarter and thanks for taking our questions. First is on lupinus. Can you maybe just talk about the quarterly cadence as we think about Q1 sales and your guidance for the year? 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. Stacy KuAnalyst at Cowen00:09:29Is 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 AUR 200. Just as we near the Phase one 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 BAF agents? Thanks so much. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:10:01Thanks, Stacy. Let me start with the first one. On Leukinus, obviously we're guiding to a range of 2.4 to $2.5 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 and 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. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:11:07It'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. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:11:44And I think that's about it. On the AUR 200, not to give you nothing here, but I think we're between now and the June, we intend to report out the data and I would just ask you to wait till then and that'll be our single ascending dose data and we'll give more steer on the program once we get there. Stacy KuAnalyst at Cowen00:12:10Thank you. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:12:12Thanks Stacy. Operator00:12:14Thank you. Next question is coming from Maury Raycroft from Jefferies. Your line is now live. Maury RaycroftEquity Research Analyst at Jefferies00:12:19Hi, good morning. Congrats on the quarter and thanks for taking my questions. I'll ask one just on guidance too. So for historically first quarter tends to be the lowest quarter. So just wondering if you're expecting second quarter to be in line or lower? Maury RaycroftEquity Research Analyst at Jefferies00:12:34And what are you seeing in the initial six weeks in second quarter that informs your the rest of your outlook for the rest of the year? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:12:42Yes, I'm not sure. I'd have to go back. I don't think 1Q is usually our lowest quarter. 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. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:13:13And that would include what we've seen historically as a soft summer. 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 Maury, 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. Maury RaycroftEquity Research Analyst at Jefferies00:13:41Got 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 02/1937 dosing protocol patent. Wondering if you just talk more about that and what the strategy and risks are there? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:14:01Well, I mean, I think we've commented on this historically. So there's really nothing new outside of the fact that we've 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 thirty month stay of execution and I'll just see that process through and we have continued work that we're doing in the organization to, I guess, would just leave it with the longevity of blue kinase is an A priority for the organization. It's all hands on deck, 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. Maury RaycroftEquity Research Analyst at Jefferies00:14:59Understood. Okay. Thanks for taking my questions. I'll hop back in the queue. Operator00:15:02Thanks. Thank you. Next question is coming from Joseph Schwartz from Leerink Partners. Your line is now live. Joseph SchwartzSenior Managing Director at Leerink Partners00:15:10Great. 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 in MFN. So could you, first of all, just help us understand where the IP is domiciled for leptokinase? 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 U. Joseph SchwartzSenior Managing Director at Leerink Partners00:15:44S, and if you can grow supply within The U. S. Over time? And then, how should we think about any exposure Aurinia has to potential MSN legislation based on the amount of government reimbursement for LUKINUS? Thank you. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:16:04There's a lot there, Joe. So let me just start with the tariff side of the equation, I guess. As you know, our API is done in Switzerland. But to be clear, we have several years worth of product that sits on U. S. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:16:22Soil. And I think that even if tariffs were depending on what the range of tariffs could be, it's on a very small percentage of our overall cost of goods at the API level. We do all our fillfinish work or our packaging work here in The U. S. So we think minimal to no impact over the next several years and then TBD as to what those tariffs would look like and what the impact would be on our API. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:16:55Of course, like most, we're working hard to ensure we have as much product in The U. S. As possible. And as I said, we've got several years here. In terms of transfer pricing, etcetera, we're watching this like everybody else. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:17:10Obviously, we're a Canadian company that does business in transfer pricing is part of how our economic model works. My understanding is it would take not an executive order but an act of Congress to actually go and impact that. So our ears are open and we're kind of watching where the market goes on this and where the President and his administration goes as it relates to not tariffs but the element of transfer pricing for ex U. S. Companies operating within The U. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:17:44S. And then lastly, the most recent executive order, your guess is as good as mine. It kind of seems like there is a directive put out there under an executive order by President Trump and then where it eventually lands, if it lands is kind of a TBD. So we're watching that as closely as you are because obviously the entire pharmaceutical and really healthcare industry is affected by the government pricing side of the business. To recall, our business is pretty evenly split between commercial pay, public pay, or excuse me, private pay the government side of the business. So obviously it's something we're watching closely. Joseph SchwartzSenior Managing Director at Leerink Partners00:18:28Very helpful. Thanks Peter. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:18:31Thank you, Joe. Operator00:18:33Thank you. Next question today is coming from Olivia Brayer from Cantor Fitzgerald. Your line is now live. Olivia BrayerAnalyst at Cantor Fitzgerald00:18:38Hi, good morning. Thank you for the question. So for AUR 200, is there anything you can say just around how many patients 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? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:19:02Yes, I think those are all good questions and we look forward to it's now almost mid May. And as we've said between now and the June, we're going to report out that SAD data. So we look forward to showing you what we've got. Obviously, in the areas of proteinuria kidney diseases and the like, there is more than one April bath ahead of us in the IGAN space. So we'll learn what we've got as it relates to others in just a short couple of weeks. Olivia BrayerAnalyst at Cantor Fitzgerald00:19:36Okay. Peter, anything you can say just around data disclosure in terms of how you guys are, will you host a call and kind of what level of details just in terms of next steps should we expect to see then? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:19:51Yes. I mean outside of the fact that we've committed to reporting out that single ascending dose data by the June, no, we're not giving any guide as to how much data and what will show in addition to that. So more to come. We got to discuss it. We got to see what the data is first because obviously this trial is ongoing and then we have to sit with our board and talk about what we want to disclose publicly as it relates to not just the program, but where we intend to go from there. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:20:23So we look forward to doing that, but it's between now and the June. Olivia BrayerAnalyst at Cantor Fitzgerald00:20:27Okay. Thanks. Looking forward to that. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:20:30Thank you. Operator00:20:33Thank you. Next question is coming from Sejal Dingra from RBC Capital Markets. Your line is now live. Sahil DhingraSenior Equity Research Associate - Healthcare at RBC Capital Markets00:20:39Hi, good morning. This is Sahil for Doug Me. Thank you so much for taking our questions. I have two. My first question is related to the SG and A expense. Sahil DhingraSenior Equity Research Associate - Healthcare at RBC Capital Markets00:20:48So that was around $20,000,000 this quarter and it was a bit below what we were we had modeled. So I wanted to know if there was any one time item in it? And how should we think about the SG and A expense going forward? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:21:03All right. So the question is on SG and A. We don't give expense level guide, but maybe Joe can give a little bit on the quarter and how to think about it as it relates to the year. Joe MillerChief Financial Officer at Aurinia Pharmaceuticals00:21:16Yes. Thank you for the question, Seal. Yes, 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 $40,000,000 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 and 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. Joe MillerChief Financial Officer at Aurinia Pharmaceuticals00:21:58But outside of that, there was nothing unusual embedded within that functional line. Sahil DhingraSenior Equity Research Associate - Healthcare at RBC Capital Markets00:22:06Okay. Then my second question is on Roche's GALCIVA that is expected where the PDUFA date is in October 2025. So how do you expect the evolution of the ELN treatment market? And what impact do you think will it have on leukotrienes adoption? Thank you. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:22:27Why 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 Doctor. Keenan, our 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 Cadaigo 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 GASVAIA has got some data and we've seen it and obviously we're filed. I think we feel pretty confident that their filing will most likely be reviewed and they have a high probability of getting approval. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:23:37Not 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 Greg KeenanChief Medical Officer at Aurinia Pharmaceuticals00:23:56you, Peter. So, first off, it's a great news for individuals and the 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 Benlystin. Greg KeenanChief Medical Officer at Aurinia Pharmaceuticals00:24:22You can imagine the opportunity for obinutuzumab to fit in that category to a B cell agents. We think nonetheless that gluconus with its strong evidence and the timeliness of benefit achieving both 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 three and four, but also in V. And so we think that it's a good day for patients. LUKOIS is going to continue to have an important role in helping patients achieve their goals. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:25:17Yes, think it comes to me comes down to speed. And while these products are obviously getting approved, if it takes two years to get the effect that we get at one year and quite frankly that we see it at three months and six months, the guidelines are calling for rapid reductions of proteinuria and these B cell agents so far have not been able to achieve the rapidity of response and reduction in proteinuria that the guidelines are calling for. So in other words, we think we have a very competitive profile. Greg KeenanChief Medical Officer at Aurinia Pharmaceuticals00:25:53Great. Thank you so much. Operator00:25:57Thank you. Next question is coming from David Martin from Bloom Burton. Your line is now live. David MartinManaging Director & Head of Equity Research at Bloom Burton & Co00:26:02Good morning. Thanks for taking my questions. My understanding is that Luke Kinus 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 with kind of sac commercial scale? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:26:24We don't have any insight into that outside of as part of their ANDA package, you'll have to show that they can actually manufacture it. So we haven't changed our position on what we believe our process is, whether they can duplicate it or find a way to do it differently is TBD. We haven't seen their actual filer package. David MartinManaging Director & Head of Equity Research at Bloom Burton & Co00:26:51Okay. And next major events in the patent litigation, what Operator00:26:58kind David MartinManaging Director & Head of Equity Research at Bloom Burton & Co00:26:58of timing should we expect and what events are coming up? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:27:03I mean, we obviously had to have filed patent infringement lawsuits. I don't think we intend to disclose major milestones in IP patent defense space. We'll 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 end of 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. David MartinManaging Director & Head of Equity Research at Bloom Burton & Co00:27:43Okay. And then one last question. What endpoints do you anticipate could differentiate AUR two hundred from other APRIL and BAF inhibitors with the Phase one SAD results? Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:27:57I think the Phase one SAD results are obviously going to give us the pharmacokinetics and the pharmacodynamics of the product. That's everything from the 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 it 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. David MartinManaging Director & Head of Equity Research at Bloom Burton & Co00:28:46Okay, thanks. That's it for me. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:28:49Thank you. Thank Operator00:28:51you. We reached the end of our question and answer session. I'd to turn the floor back over for any further or closing comments. Peter GreenleafPresident & Chief Executive Officer at Aurinia Pharmaceuticals00:28:58Well, 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. Operator00:29:08Thank 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.Read moreParticipantsExecutivesAndrea ChristopherHead of the Corporate Communications & Investor RelationsPeter GreenleafPresident & Chief Executive OfficerJoe MillerChief Financial OfficerGreg KeenanChief Medical OfficerAnalystsStacy KuAnalyst at CowenMaury RaycroftEquity Research Analyst at JefferiesJoseph SchwartzSenior Managing Director at Leerink PartnersOlivia BrayerAnalyst at Cantor FitzgeraldSahil DhingraSenior Equity Research Associate - Healthcare at RBC Capital MarketsDavid MartinManaging Director & Head of Equity Research at Bloom Burton & CoPowered by