Aurinia Pharmaceuticals Inc. Price & Performance (AUPH)

Thank you, operator, and thank you to everyone for joining today's call and webcast. Joining me on the call this morning are Peter Greenleaf, Aurinia's President and Chief Executive Officer Joe Miller, Aurinia's Chief Financial Officer Doctor. Greg Keenan, Aurinia's Chief Medical Officer. Today, we will review and discuss Aurinia's fourth quarter and full year 2024 financial [indiscernible] and provide an update on recent corporate progress as communicated in the company's press release and annual report on Form 10 ks issued this morning. For more information, please refer to Aurinia's filings with the U. S. Securities and Exchange Commission and Canadian Securities Authorities. Which are also available on Aurinia's website at auriniapharma.com. During today's call, Aurinia may make forward looking statements. Based on current expectations. These forward looking statements are subject to a number of significant risks and uncertainties. And actual results may differ materially. For a discussion of factors that could affect Aurinia's future financial results and business, please refer to the disclosures in Aurinia's press release. Annual Report on Form 10 ks and all other filings with the U. S. Securities and Commission and Canadian securities authorities. Please note that all statements made during today's call are current as of today 02/27/2025.

Unless otherwise noted and are based upon information currently available to us. Except as required by law, Aurinia assumes no obligation to update any such statements. Now, let me turn the call over to Avernia's President and CEO, Peter Greenleaf. Peter?

Thanks, Andrea, and good morning, everyone. 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 the 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 twenty twenty four. For the fourth quarter of twenty twenty four, total revenue was $59,900,000 up 33% from $45,100,000 in the same period of 2023. For the full year 2024, total revenue was $235,100,000 up 34% from $175,500,000 in 2023. For the fourth quarter of twenty twenty four, net product sales of Flukinus the first FDA approved oral therapy for the treatment adult patients with active LN were $57,600,000 up 36% compared to $42,300,000 in the same period of 2023, For the full year of 2024, net product sales were $216,200,000 up 36% from $158,500,000 in 2023. The increase in both periods is primarily due to an increase in the number of lube kinase cartons sold to specialty pharmacies, driven by further LN market penetration. For three months ended 12/31/2024, cash flow generated from operations was $30,100,000 compared to $14,300,000 in the same period of 2023. For the year ended 12/31/2024, cash flow generated from operations was $44,400,000 compared to cash flow used in operations of $33,500,000 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 $358,500,000 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 lupus kinase 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 lupkinis restarts. Second, we expect the new ACR lupus nephritis treatment guidelines to help drive positive momentum for lupinus this year and we're continuing to create a treat to target mindset among rheumatologists that drives the overall treatment urgency screen and treat lupus nephritis more aggressively. Third, we continue to reinforce the impressive three year after to clinically differentiate lube kinase 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 $250,000,000 to $260,000,000 and net product sales in the range of $240,000,000 to $250,000,000 for 2025. Finally, we are also continuing to advance the development of our pipeline product AUR200, a potentially best in class dual AFPIL inhibitor for the potential treatment of a range of autoimmune diseases. We initiated a Phase one study last September and expect to report out initial results from this study in the second quarter of twenty five 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 [indiscernible] For the three months ended 12/31/2024, total revenue was 59,900,000.0 compared to $45,100,000 for the same period of 2023. For the year ended 12/31/2024, total revenue was $235,100,000 compared to $17,075,500,000.0 dollars in 2023. As Peter mentioned, we had cash, cash equivalents restricted cash and investments of $358,500,000 as of 12/31/2024 and generated cash flows from operations 44,400,000.0 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 02/25/2025, the company has repurchased approximately 9,700,000.0 of its common shares for approximately $70,000,000 since the launch of the program in the first quarter of twenty twenty four. For the three months ended 12/31/2024, cost of revenue was $5,600,000 compared to $5,400,000 in the same period of 2023. For the year ended 12/31/2024, cost of revenue was 28,200,000.0 compared to $14,100,000 in 2023. The increase for the full year is primarily due to the amortization of the finance rate of use lease asset recognized in connection with the mono plant which was placed into service in late twenty twenty three and therefore only partially impacted by prior year cost of revenue.

For the three months ended 12/31/2024, gross margin was 91% compared to 88% in the same period of 2023. For the year ended 12/31/2024, gross margin was 88% compared to 92% in 2023. [indiscernible] the three months ended 12/31/2024, total operating expenses were $61,500,000 compared to $74,800,000 in the same period of 2023. For the year ended 12/31/2024, total operating expenses were $239,800,000 compared to $267,200,000 in 2023. The decrease in both periods is primarily due to lower personnel costs including share based compensation and overhead costs, 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-three hundred 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 12/31/2024, net income was $1,400,000 or $0.01 of earnings per share compared to net loss $26,900,000 or $0.19 of net loss per share in the same period of 2023. For the year ended 12/31/2024, net income was $5,800,000 or $0.04 of earnings per share compared to a net loss of $78,000,000 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 of AUR200 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. Our first question is from Stacy Ku with TD Cowen. 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 and about 2025, can you give us some more detail around addition to the ACR guidelines. Maybe some more details on these prescriber segments. And then On 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 clean or infer from it? 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 sort of post our restructuring maximizing the opportunity as it relates to LoopKines. As we went through in the call, I think we've got four key areas we're focused on. And 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 our SLE patients that progressed to worsening outcomes and they present, well, they present probably originally at a primary care 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 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 that we're able to look at in a blinded fashion. So the rheumatology, high prescribing rheumatology offices, one area, hugely important. The guidelines you mentioned in your question, hugely important since we know that there's an under diagnosis and an under treatment 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 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 focus them down against two segments that we think are critically important. On your second question, which focuses on AUR200, as you heard on the Paul, we're looking forward to disclosing what we see from our our single ascending dose trial that's ongoing and will lead out at the end 2Q this year.

I think what you can expect to see are normal pharmacodynamics and normal pharmacokinetic data. Obviously, in the April Bath 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 in the MAD study and what structure we actually use in that study as we progress out of the SED and into the MAD. I don't think I missed anything there. Did I Greg?

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 luke kinase growth beyond 2025? 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 AUR200, 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 at this point about half life and potential dose frequency for your candidate? Thank you, guys. [indiscernible] long term guidance on lukinis, but you can see what we've sort of centered our metrics upon and it's listen, this product has been on the 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-two hundred and NASAD data, I will just hold back on saying what we will or won't [indiscernible] think as we move into the MAD study, it would probably be good and there'll probably be an expectation out there that will give some steer as to how we're going to conduct the MAD. But I guess I would just ask that we get this AD data first, see what it shows us, think it'll be really strong context for what we think we have in this versus others that are also doing development in the space. And then the next natural question is, well, how does that inform the MADS 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?

Yes. I guess I would go back to what I just said. Let us get the SAD data first and then we'll 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 Okay, understood. Looking forward to it. Thank you guys. Thanks, Olivier.

Our next question is from Farzin Hake with Jefferies. Hi, this Amin on for Maury.

Thank you for taking our questions. Two from us.

One on the guidance just following up with the previous question. You issued a guidance of two fifty two forty to two fifty and it seems to be somewhat conservative given the 4Q run rate. What are you seeing in initial two months as of this year that informs you the commercial outlook for 2025?

And then on exclusivity, [indiscernible] 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 twenty twenty eight?

Yes.

Let me 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 year.

As you may see, obviously, the low end of that projection is flattish to slightly up versus where we were in Q4. The higher end of that range obviously gets us into 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 there 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 of her obviously, we've been aware that ANDA filings will begin this year. Guidance for its unique chemical entity and obviously also the unique dosing paradigm, which could take us all the way out to 02/1937. As any company would and we fully intend to do, we fully intend to vigorously defend Loopkiness and our intellectual property rights protecting the So more to come as things continue to evolve here. But nothing's changed in terms of the dates and times as far as it Thank you for the question.

Thanks.

Our next question is from Joseph Schwartz with Leerink 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 PSS for the final quarter in 2024.

Guess I'm 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 we be thinking about and trajectory the launch without metrics like this? And then one on AUR200, dividend has a lower KDAIC50 as compared to other [indiscernible] 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, we want to state what we've reported, not necessarily what speculative. So as we said on the call, we're now five years into this. We're into our fifth year on demand. And we believe confidently that our historical financial results provide enough insights 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 30% this year in 2024 and we're guiding luke kinase revenues this year at $240,000,000 to $250,000,000 and at a total company basis, dollars $250,000,000 to $260,000,000 We made the decision at year end because we thought it was the best time. I think you mentioned midyear. We actually believed that doing it now was was the best time to do it. We look forward to reporting out on the key commercial strategy areas that 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 are referencing information that had been reported and presented at the American College Rheumatology Meeting twenty twenty two And what you alluded to was the fact that AUR-two hundred 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 AUR200 with the work we've done thus far pre clinically is very attractive with regard to the amount of compound you need and perhaps the frequency with which you need to give the drug. That is [indiscernible] milligram per milligram basis and perhaps less frequent dosing. Of course, we're doing conducting the single ascending dose study right now as has been discussed earlier 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 information at this point and we're ready to move forward.

Our next question is from Ed Arcee with H. C. Wainwright.

Hey, guys. Thanks for taking my questions. Two for me.

Firstly, ask again On the ACR treatment guidelines, as you mentioned, one of the key drivers for continuing growth wanted to get your perspectives on Your thoughts on the impact of prescriber perspectives and ultimately their script writing and uptake of leukinis especially since historically Scriptwriting from rheumatologists has been a bit more difficult penetrate then nephrologists.

And then secondly, with regard to AUR200 Just wondering if you help us understand As you think about the timeline coming out of the SAD and then later this year into the MAD studies What's the the longer time 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. Hugely beneficial for the market treatment patients and physicians. One is early diagnosis. And treat to target guidelines, basically 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, And we know today that somewhere around when they hit those target levels, only thirty percent 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 no matter what the product is, there's more of a mindset to to a time period where the protein area goes down and then selectively remove medication, which we know from our data [indiscernible] 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.

We have not seen massive change at least in the macro data that we have in terms of earlier diagnosis yet, but we 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 ULR guidelines and the Codigo 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.

Terms of your question on AUR200 time, and once we get out of this ad into the MAD our longer term timelines 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 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 MAD study more to come. Thank you for the questions Ed.

Thank you. This concludes our question and answer session. Would like to hand the floor back over to Peter Greenleaf 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.