Aurinia Pharmaceuticals Inc

Greetings and welcome to the Arinia Pharmaceuticals fourth quarter and full year 2024 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Andrea Christopher, Head of Corporate Communication and Investor Relations for Arinia. Thank you. You may begin.

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, Arania's President and Chief Executive Officer, Joe Miller, Arania's Chief Financial Officer, and Dr. Greg Keenan, Arania's Chief Medical Officer. Today, we will review and discuss Arania's fourth quarter and full year 2024 financial results and provide an update on recent corporate progress, as communicated in the company's press release and annual report, on Form 10K issued this morning. For more information, please refer to ARINIA's filings with the U.S. Securities and Exchange Commission and Canadian Securities Authorities, which are also available on ARINIA's website at ARINIApharma.com. During today's call, ARINIA 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 Arrhenius' future financial results and business, please refer to the disclosures in Arrhenius' press release, annual report on Form 10-K, 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, February 27, 2025, unless otherwise noted, and are based upon information currently available to us. Except as required by law, ARINIA assumes no obligation to update any such statements. Now, let me turn the call over to ARINIA's President and CEO, Peter Greenleaf. Peter?

Thanks, Andrea, and good morning, everyone. I want to thank you all for joining us on today's call. On this morning's call, I'll provide an update on our fourth quarter and full year 2024 results and provide an update on our 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 operational efficiency, we achieved significant growth in total revenue and record-setting net product sales in the fourth quarter of 2024. For the fourth quarter of 2024, total revenue was $59.9 million, up 33% from $45.1 million in the same period of 2023. For the full year 2024, total revenue was $235.1 million, up 34% from $175.5 million in 2023. For the fourth quarter of 2024, net product sales of Flukinus increased the first FDA-approved oral therapy for the treatment of adult patients with active LN, were $57.6 million, up 36%, compared to $42.3 million in the same period of 2023. For the full year of 2024, net product sales were $216.2 million, up 36%, from $158.5 million in 2023. The increase in both periods is primarily due to an increase in the number of loop kinase cartons sold to specialty pharmacies driven by further LN market penetration. For three months ended December 31st, 2024. Cash flow generated from operations was $30.1 million. compared to $14.3 million in the same period of 2023. For the year ended December 31, 2024, cash flow generated from operations was $44.4 million, compared to cash flow used in operations of $33.5 million in 2023. Following last year's strategic restructuring, we are pleased with how our cash flow improved throughout 2024. Exiting the year, we have cash, cash equivalents, restricted cash, and investments of $358.5 million as of December 31, 2024. As we are now into our fifth year on the market, we believe that our historical financial results provide sufficient insight into the health of our business to project forward-looking results. Therefore, we're not providing specific patient-level metrics. With our strong 36% sales growth for Lupkinis in 2024, we are poised for continued success and have a commercial strategy that is focused on four key growth drivers. First, we've sharpened our focus on expanding our base of business at academic medical centers and lupus centers. We've also targeted key rheumatology prescriber segments and identified key lupus nephritis patient types. This would include newly diagnosed patients, patients who are only on MMF and steroids, patients receiving treatment but not achieving treatment potential targets, and potential for loop kinase restarts. Second, we expect the new ACR lupus nephritis treatment guidelines to help drive positive momentum for loop kinase this year, and we're continuing to create a treat-to-target mindset among rheumatologists, that drives the overall treatment urgency to screen and treat lupus nephritis more aggressively. Third, we continue to reinforce the impressive three-year efficacy data and safety data from our Aurora clinical program to clinically differentiate lupkinus and position it earlier in the treatment paradigm. And lastly, we're focused on improving continuity of care for lupus nephritis patients by growing our hospital business and keeping patients on therapy for longer periods of time. We're very pleased to start 2025 in a solid position with a highly efficient organization focused on loop kinase growth and therefore expect total revenue for 2025 in the range of $250 to $260 million and net product sales in the range of $240 to $250 million for 2025. Finally, we are also continuing to advance the development of our pipeline product, AUR200, a potentially best-in-class dual-AF-APRIL inhibitor for the potential treatment of a range of autoimmune diseases. We initiated a Phase I study last September and expect to report out initial results from this study in the second quarter of 2025. I'd now like to turn the call over to Joe Miller, our CFO, for a more detailed review of the fourth quarter and full-year financial results. I'll then return to end the call for a quick wrap-up and 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 fourth quarter and full-year 2024 financial results. For the three months ended December 31, 2024, total revenue was $59.9 million, compared to $45.1 million for the same period of 2023. For the year ended December 31, 2024, total revenue was $235.1 million compared to $175.5 million in 2023. As Peter mentioned, we had cash, cash equivalents, restricted cash, and investments of $358.5 million as of December 31, 2024, and generated cash flows from operations of $44.4 million. 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. As of February 25th, 2025, the company has repurchased approximately 9.7 million of its common shares for approximately 70 million U.S. dollars since the launch of the program in the first quarter of 2024. For the three months ended December 31, 2024, cost of revenue was 5.6 million compared to 5.4 million in the same period of 2023. For the year ended December 31, 2024, cost of revenue was $28.2 million compared to $14.1 million in 2023. The increase for the full year is primarily due to the amortization of the finance right of use lease asset recognizing connection with the model plant, which was placed into service in late 2023 and therefore only partially impacted by prior year cost of revenue. For the three months ended December 31, 2024, gross margin was 91% compared to 88% in the same period of 2023. For the year ended December 31, 2024, gross margin was 88% compared to 92% in 2023. For the three months ended December 31, 2024, total operating expenses were $61.5 million compared to $74.8 million in the same period of 2023. For the year ended December 31, 2024, Total operating expenses were $239.8 million compared to $267.2 million in 2023. The decrease in both pre-arrays is primarily due to lower personnel costs, 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 AUR 300 development program. These savings in both periods are partially offset by a one-time termination benefits, contract terminations, and other costs associated with our strategic restructuring efforts undertaken throughout 2024. For the three months ended December 31, 2024, net income was 1.4 million or one cent of earnings per share compared to net loss of 26.9 million or 19 cents of net loss per share in the same period of 2023. For the year ended December 31, 2024, net income was $5.8 million, or $0.04 of earnings per share, compared to a net loss of $78 million, or $0.54 of net loss per share in 2023. With that, I'd like to hand the call back over to Peter for some closing remarks. Peter?

Thanks, Joe. In summary, implementing a highly focused industry-leading operational strategy has allowed us to lean further into the highest growth drivers for the commercial loop kindness business, accelerate clinical development of AOR 200, and further strengthen our balance sheet. We now have more flexibility to engage in activities that can strategically enhance our business. I want to thank you all for your time today. We'll now open the lines for any questions. Operator?

Thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Please proceed with, one moment please while we pull up your questions. Our first question is from Stacy Ku with TD Cowan. Please proceed with your question.

Hi, good morning. This is Vish on for Stacy and congrats on the year and thanks so much for taking our questions. We had a couple. So thanks for talking about your kind of growth, key growth drivers. And so as we think about those in about 2025, can you give us some more details around with the current sales force, how you are maximizing the opportunity for look kindness, especially given the addition of to the ACR guidelines. Maybe some more details on these prescriber segments. And then the second question is probably on the AUR200 asset. So we're really looking forward to the Q2 readout. Can you remind us what sort of data we can expect and what we'll be able to kind of glean or infer from it? Thank you very much.

Vish, thank you for the questions. Let me start with the first and then I might ask Greg to jump in if I miss anything on the second. Your first question on you know, sort of post our restructuring, maximizing the opportunity as it relates to luteinus. As we went through in a call, I think, you know, we've got four key areas we're focused on. And let me try to at least relate two of those to how we address them post the restructuring. The first is a strong focus on rheumatology. As we all know, LN patients are SLE patients that progress to worsening outcomes. And they present, well, they present probably originally at a primary care physician's office, but once diagnosed, they're with a rheumatologist. And if our goal is to drive the ACR guidelines and what they propose should be the treatment of the disease and the diagnosis of the disease, initial diagnosis and initial treatment really should happen aggressively within the rheumatologist's office. So as we restructured our group, one of the things we put a very high priority on was focusing on high prescribing, SLE and LN offices, which we would pick up from both codes through actually looking at patient, not actual patient, but patient charts that we're able to look at in a blinded fashion. So the high prescribing rheumatology offices, one area. Hugely important. The guidelines you mentioned in your question, hugely important since we know that there's an underdiagnosis and an undertreatment of the disease. And then lastly, we've focused our resources, again, against the hospital segment because we know that major medical centers around the country that have lupus centers, that are lupus centers and have lupus clinics, are critically important to capturing patients early and in their diagnosis if they have elevated proteinuria. So those are just a few examples of how we've not just tightened our resources, but focused them down against two segments that we think are critically important. On your second question, which focuses on AUR200, as you heard on the call, we're looking forward to disclosing what we see from our single ascending dose trial that's ongoing and will read out at the end of 2Q this year. I think what you can expect to see are normal pharmacodynamics and normal pharmacokinetic data. Obviously, in the April BAFSS space, there are some important markers such as IgG, IgA, IgM that we would hope to be able to show as well. This data is going to be critically important in understanding what dose we take into the MAD study and what structure we actually use in that study as we progress out of the SAD and into the MAD. I don't think I missed anything there, did I, Greg? No. Thank you. Next question.

Our next question is from Olivia Breyer with Cantor Fitzgerald.

Hi, good morning. Thank you for the questions. How are you all thinking about loop kindness growth beyond 2025? It looks like you're guiding to about 13% this year at the midpoint. So is low double digits the right way to think about growth rate these next few years? And then on AOR 200, will you guys actually be disclosing the dose for the MAD portion and indication selection in that second quarter update? And is there anything you can tell us at this point about half-life and potential dose frequency for your candidate? Thank you, guys.

Thanks, Olivia. So we haven't historically and don't intend to today give long-term guidance on Leukinus, but you can see what we've sort of centered our metrics upon. And it's, listen, this product's been on the market now for four going into its fifth year. And we think those historical trends are the best way to think about the product on a go-forward basis. So hopefully that's helpful. On AUR 200 and the SAAD data, I will just hold back on saying what we will or won't disclose because we actually have to see the data first. I think as we move into the MAD study, It would probably be good, and there would probably be an expectation out there that we'll give some steer as to how we're going to conduct the MAD. But I guess I would just ask that we get this MAD data first, see what it shows us. I think it'll be really strong context for what we think we have in this versus others that are also doing development in this space. And then the next natural question is, well, how does that inform the MADD study, which we're just a few months away from, so look forward to having that conversation.

Okay, understood. Thanks, Peter. What about in terms of timelines for, obviously, I know we have to see the SAD data first, but in terms of next steps and timelines for that MAD portion of the study, can you guys put any kind of numbers or timelines around that?

Yeah, I guess I would go back to what I just said. Let us get the SAD data first, and then we'll tell you what we intend to do in the MAD, and that will inform how long that's going to take and what our projections are to completion of that. So more to come.

Okay, understood. Looking forward to it. Thank you, guys.

Thanks, Olivia.

Our next question is from Farzan Haidt with Jefferies.

Hi, this is Amin An for MORI. Thank you for taking our questions. Two from us. One on the guidance, just following up with the previous question. You issued the guidance of 250, 240 to 250, and it seems to be somewhat conservative given the 4Q round rate. What are you seeing in initial two months of this year that informs you the commercial outlook for 2025? And then on exclusivity, Lipokinase has orange book exclusivity protection until January 26, if I'm not mistaken. And as expected, an NDA was filed by Lotus earlier this month. Maybe talk about your strategy there and is the base case assumption is still that the earliest generic can come to market in first half 28?

Yeah, let me start on the first question, which was our guidance range and what have we seen early in the year. I think our guidance range is, as we said on the call, very much driven by what we know now after being in our fifth year on the market. And looking very closely at our historical financial results and using that to sort of project out where we see the year. As you may see, obviously, the low end of that projection is, you know, sort of flattish to slightly up versus where we were in Q4. the higher end of that range, you know, obviously gets us into a higher growth category. So we feel good about the numbers across the board. Do we think they're conservative? No, we think they're based on what we're seeing in the marketplace today. On your second question, I think your point was, it was a little bit of a reiteration of some dates and times and The mid-portion of 2028, I think we can reaffirm, but I do want to just confirm for folks that we're aware, obviously, we've been aware that ANDA filings will begin this year. We have a robust patent portfolio covering leucinase for its unique chemical entity and obviously also the unique dosing paradigm, which could take us all the way out to 2037. As any company would, and we fully intend to do, we fully intend to vigorously defend Lucaina Center intellectual property rights, protecting the product. So more to come as things continue to evolve here, but nothing's changed in terms of the dates and times, Farson. Thank you for the question.

Thanks.

Our next question is from Joseph Schwartz with Learing Partners.

Hey, all. This is Will for Joe today. Thanks for taking our question. Congrats on the progress this quarter. So just two from us. I guess first, could we just go back and talk a little bit more about your decision to no longer report PSF for the final quarter in 2024? I guess we're just trying to understand why you might make that switch in the middle of the year rather than something as you move forward in 2025. How should you be thinking about a trajectory to launch about metrics like this? And then one on AUR 200. Given it has a lower KD and IC50 as compared to other anti-able assets, is it fair to assume that the higher potency should allow for a lower or less frequent dose? I guess when we're looking at the NHP data, it looks like dosing was once weekly, which is in line with other assets. So can you help us understand this dynamic and the potential differentiation here versus other therapies in development? Thank you.

So I'll start with the first question, then I'll ask Greg to jump in and obviously remind, I mean, want to state of what we've reported, not necessarily what's speculative. So as we said on the call, we're now five years into this, or we're into our fifth year on the market. And we believe confidently that our historical financial results provide enough insight, sufficient insight into the health of our business to project it on a forward basis. We're excited to have grown the product more than 35% this year in 2024, and we're guiding Loop Kindness revenues this year at $240 to $250, and at a total company basis, $250 to $260 million. We made the decision at year end because we thought it was the best time. I think you mentioned mid-year. We actually believed that doing it now was the best time to do it. We look forward to reporting out on the key commercial strategy areas that I mentioned on the call and mentioned in the previous question as we focused on them as our drivers for 2025 and beyond. Greg, do you want to take the next one?

Sure. So you were referencing information that had been reported or presented at American College Rheumatology Meeting 2022. And what you alluded to was the fact that AUR200 in the preclinical models that we've conducted, we've identified that there's a lower KD and lower IC50. Lower means resulting in equivalent impact with lower amounts of compound, just like you're alluding to. So we think that the potency of AUR200 with the work we've done thus far preclinically is very attractive with regard to the amount of compound you'd need and perhaps the frequency with which you'd need to give the drug. That is less milligram per milligram basis and perhaps less frequent dosing. Of course, we're conducting the single ascending dose study right now as has been discussed earlier. And in people, we'll learn exactly what will be the take forward frequency of dosing and the milligram amount that would be appropriate in diseases that we select later. So thanks for the question. Good information at this point, and we're ready to move forward.

Our next question is from Ed Arcee with HC Wainwright.

Hey, guys. Thanks for taking my questions. Two for me. Firstly, I wanted to ask again, on the ACR treatment guidelines, as you mentioned, one of the key drivers for continuing growth, I wanted to get your perspectives on your thoughts on the impact of prescriber perspectives and ultimately their script writing and uptake of Leukinus, especially since You know, historically, script writing from rheumatologists has been a bit more difficult to penetrate than nephrologists. And then secondly, with regard to AUR 200, just wondering if you could help us understand, excuse me, As you think about the timeline coming out of the SAD and then later this year into the MAD studies, what's the longer term timeline look like as you think about ultimately selecting an initial indication and moving into an early phase two? Thank you.

Thanks for the question, Ed. On the ACR treatment guidelines, to oversimplify for folks on the call the two biggest areas, and there really are, actually I'll go through quickly three, that we see as being hugely beneficial for the market, treatment, patients, and physicians. One is early diagnosis and treat-to-target guidelines. do proteinuria screens on every patient that has SLE when they enter the office, and that's a rheumatologist's office. That doesn't happen today. Second, when they hit a target level, UPCR, to treat. And we know today that somewhere around when they hit those target levels, only 30% of those patients even get treated. Huge opportunity. And then lastly, regardless of the product that they're on, that they need to be kept on that product for up to three to five years. And we know today that no matter what the product is, there's more of a mindset to treat to a time period where the proteinuria goes down and then selectively, potentially, they remove medication, which we know from our data that patients then have to be restarted on the product. So all three of those are benefits to patients with LN, the overall market, and of course our product. So impact on behaviors, what I can tell you is greater than 50% of our prescriptions today come from rheumatologists, and that number is slowly growing. We have not seen massive change, at least in the macro data that we have in terms of earlier diagnoses yet, but we have to recognize that the ACR guidelines only came out in November. So I think there's plenty of time ahead where These guidelines, along with the ULAR guidelines and the Cadego guidelines, are all very positive for the LN market going forward and our product. So we'll look forward to reporting numbers on market, Ed, as we go forward, but that's the high level. We're seeing some impact, and we look forward to seeing more impact on actual treatment and diagnosis behaviors moving forward. In terms of your question on AUR200, time, And once we get out of the SAD, into the MAD, our longer-term timelines, well, what I would say is let us get through the single ascending dose trial. Let us articulate what our approach to the multi is going to be. And I think that will, whether we give guidance to longer term or not, it will at least give some steer towards where we're going and how long that might take. But I think we got to get through this sad. It's not far away. Look at what those kinetics and dynamic data tell us and use that as an informed decision to move into the MADS study. So more to come. Thank you for the questions, Ed.

Thank you. This concludes our question and answer session. I would like to hand the floor back over to Peter Greenlee for any closing comments.

I want to thank you all for joining us today. We look forward to a strong 2025, and we'll keep you updated along the way. Have a great day, folks.

This concludes today's presentation. You may disconnect your lines at this time. Thank you for your participation.