Aurinia Pharmaceuticals Inc

Greetings and welcome to Arena Pharmaceutical's third quarter 2024 earnings call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require appropriate 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 Communications and Investor Relations for Arenaforms Instituticals. Thank you. You may now 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, Arena's President and Chief Executive Officer, Joe Miller, our Chief Financial Officer, and Dr. Greg Keenan, our Chief Medical Officer. Today, we will review and discuss ARINIA's 2024 third quarter financial and operational results, as communicated in the company's press release issued this morning. The company also filed its quarterly financial statements on Form 10-Q 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 discussion of factors that could affect Arrhenius' future financial results and business, please refer to the disclosures in Arrhenius' press release, its quarterly report on Form 10-Q, and its annual report on Form 10-K, and all of its recent 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 November 7, 2024, unless otherwise noted and are based upon information currently available to us. Except as required by law, Arunia assumes no obligation to update any such statement. Now, let me turn the call over to Arunia's President and CEO, Peter Greenleaf. Peter?

Thanks, Andrea, and good morning, everyone. I want to thank everybody for joining us on the call today. On this morning's call, I'll provide the details on our third quarter business metrics and how we are preparing for the rest of the year. I'll then turn the call over to Joe Miller, our CFO, to provide additional details on our financial results. With continued focus on commercial execution, we achieved a strong third quarter performance. For the third quarter of 2024, total net revenue was $67.8 million, compared to $54.5 million for the same period in 2023, representing a 24% growth. For the first nine months of 2024, total net revenue was $175.3 million compared to $130.4 million for the same period in 2023, representing 34% growth. For the third quarter of 2024, net product revenue was $55.5 million compared to $40.8 million for the same period in 2023, representing 36% growth. For the first nine months of 2024, net product revenue was $158.6 million compared to $116.2 million for the same period in 2023, this representing 36% growth. The company generated approximately $17 million in cash flow from operations in the third quarter, reflecting continued strong operational execution and further strengthening of our financial positions. The company had cash, cash equivalents, restricted cash and investments at $348.7 million as of September 30th, 2024. In terms of commercial performance and metrics for the third quarter, we added 364 PSFs and 146 new patients who were either restarting loop kinase or receiving it through the hospital pharmacy. Together, these total 510, compared to 436 PSFs in the prior year third quarter, representing 17% year-over-year growth. We also achieved 25% growth in total patients on loop kinase therapy, with approximately 2,422 patients on therapy as of September 30th of 2024. This compared to 1,939 patients as of September 30th of 2023. This significant year-over-year growth was driven by patients restarting loop kinase after being off therapy for an extended period of time, as well as hospital fills and maintaining high persistency rates year-over-year. We're encouraged by the continued increase in our persistency rates across all time periods and that our rapid conversion time and overall conversion and adherence rates remain consistent and consistently at high levels. Finally, we're off to a strong fourth quarter start, and we're looking forward to communicating those results next year when we report full year results. As a result of our strong commercial performance, we're reiterating our net product revenue guidance range of $210 million to $220 million. In summary, we're very pleased with our net revenue and cash flow from operations figures for the quarter. which represent record performance for the company. We also achieved several very important milestones in the third quarter. We announced that the first participant has been dosed in a phase one study of AUR200, our Bath-April dual antagonist for autoimmune disorders. We look forward to sharing initial results from this study and advancing clinical developments into 2025. We also announced that Japanese regulatory authorities approved Lupkinus to treat lupus nephritis, triggering the recognition of an additional $10 million milestone payment in the quarter. The company anticipates low double-digit royalties on net sales once Lupkinus is launched in Japan. Our successful partnership with Otsuka has allowed us to bring Lupkinus to lupus nephritis patients across Europe and now Japan, where there's a high rate of lupus nephritis. Additionally, there were five presentations on lupkinis at the recent American Society of Nephrology Kidney Week meeting. These presentations described the critical role lupkinis plays in advancing the treatment of lupus nephritis, especially in populations disproportionately impacted by the disease. An analysis of baseline data from the ENLIGHT-LN registry provided important insights into real-world treatment patterns. Data were also presented supporting a growing body of evidence that Leukinus, through a unique mechanism of action, favorably affects podocytes, which in turn should improve kidney health in adults with active lupus nephritis. Now, let me shift gears and discuss today's announcement that we are restructuring our operations to sharpen our commercial and R&D efforts. Our goal through this initiative is to implement a highly focused, industry-leading operational strategy that will enable us to lean further into key areas of the commercial loop kindness business that have historically delivered optimal returns by accelerating clinical development of AUR 200. We also expect the restructuring to further strengthen our balance sheet. Going forward, our targeted commercial strategy for Loop Kindness will allow us to lean further into key areas of business that have historically been our highest growth drivers. As part of the restructuring, we will be reducing our workforce by approximately 45%. We anticipate that this initiative will further improve operational efficiency with anticipated post-restructuring annualized cash-based operating expense savings of more than $40 million. This initiative will further strengthen our financial position and provide more flexibility to engage in future business-building activities. I'd like to now turn the call over to Joe Miller, our CFO, for a more detailed review of our financial results. I'll then return at the end of the call for a quick recap and to open up the line to any questions you might have. Joe?

Thank you, Peter, and good morning, everyone. Let's take a few minutes and go into detail regarding our financial results for the third quarter and nine months ended September 30, 2024. As of September 30, 2024, we had cash, cash equivalents, restricted cash, and investments of $348.7 million compared to $350.7 million as of December 31, 2023, and $330.7 million as of June 30, 2024. The change from the year-end balance is primarily related to the continued investment in commercialization activities, and post-approval commitments of Loop Kindness, model plan payments, share repurchases, and restructuring-related payments offset by an increase in cash receipts from Loop Kindness sales and cash payments from Otsuka. The increase in the balance over prior quarter is due to cash receipts from Loop Kindness sales and cash payments from Otsuka partially offset by commercialization activities, model plan payments, and inventory purchases. Cash flow generated by operations was $17 million for the three months ended September 30, 2024, compared to $13.3 million in cash flow used for the three months ended September 30, 2023. Cash flow generated by operations was $14.3 million for the nine months ended September 30, 2024, compared to $47.8 million in cash flow used for the nine months ended September 30, 2023. Total net revenue was $67.8 million for the three months ended September 30, 2024, and $54.5 million for the same period in 2023. Year-to-date total net revenue was $175.3 million for the nine months ended September 30, 2024, compared to $130.4 million for the same period in 2023. Net product revenue was $55.5 million for the three months ended September 30, 2024, and $40.8 million for the same period in 2023. Net product revenue was $158.6 million for the nine months ended September 30, 2024, and $116.2 million for the same period in 2023. The increase in both periods is primarily due to increased loop kindness sales to the company's two main specialty pharmacies, driven predominantly by further penetration of the LN market. Additionally, for the nine months ended September 30, 2024, Arunia had sales of semi-finished product to Otsuka as Otsuka continues to commercialize in its territories. License, collaboration, and royalty revenue was $12.3 million. and $13.7 million for the three months ended September 30, 2024 and September 30, 2023, respectively, and $16.7 million and $14.2 million for the nine months ended September 30, 2024 and September 30, 2023, respectively. The revenue is primarily due to a $10 million milestone recognized in the third quarter of 2024 for the Japanese Ministry of Health, Labor, and Welfare approval of Loop Kindness and a $10 million milestone recognized in the third quarter of 2023 for pricing and reimbursement approval, coupled with manufacturing services revenue from Otsuka related to the shared capacity services that commenced in late of June 2023. Cost of sales were $6 million and $6.8 million for the three months ended September 30, 2024 and September 30, 2023, and $22.7 million and $8.8 million for the nine months ended September 30, 2024 and September 30, 2023, respectively. The increase for the nine-month period is primarily due to the amortization of the model plan finance right of use asset, which was placed in the service in late June 2023, and therefore only partially impacting prior year results. Gross margin for the three months ended September 30th, 2024 was 91% compared to 88% for the three months ended September 30th, 2023. Gross margin for the nine month ended September 30th, 2024 was 87% compared to 93% for the nine months ended September 30th, 2023. SG&A expenses inclusive of share based compensation were 42.4 million and 47.8 million for the three months ended September 30th, 2024 and September 30th, 2023 respectively. SG&A expenses inclusive of share based compensation were 135 million for the nine months ended September 30th, 2024 compared to $145 million for the same period ended September 30, 2023. The decrease in both periods is primarily due to lower employee-related costs, including share-based compensation and overhead, as a result of reduction in general and administrative headcount, which occurred late in the first quarter of 2024. Research and development expenses, inclusive of share-based compensation, were $3 million for the three months ended September 30, 2024, compared to $13.6 million for the three months ended September 30, 2023. R&D expenses, inclusive of share-based compensation, was $12.7 million and $39.4 million for the nine months ended September 30, 2024 and September 30, 2023, respectively. The primary drivers for the decrease in both periods were lower employee costs related to a reduction in headcount, which occurred late in the first quarter of 2024, a decrease of expenses related to ceasing ARENIA's AUR 300 development program, and the timing of expenses related to developing AUR 200. For the three months ended September 30th, 2024, Arunia recorded a net income of $14.4 million or $0.10 net income per common share as compared to a net loss of $13.4 million or $0.09 net loss per common share for the three months ended September 30th, 2023. For the nine months ended September 30th, 2024, Arunia recorded net income of $4.3 million or $0.03 net income per common share as compared to a net loss of $51.1 million or $0.36 net loss per common share for the nine months ended September 30, 2023. With that, I'd like to hand the call back over to Peter for some closing remarks.

Peter? Thanks, Joe. We're looking forward to a strong finish for 2024 and heading into 2025 with a highly efficient organization focused on loop kindness growth and advancing AUR 200. I want to thank you all for your time today. We'll now open the lines for any questions you might have. Operator?

If you wish to ask a question, please press star followed by one on your telephone and wait for your name to be announced. We ask that you limit your questions to one and one follow-up so you're able to take as many questions as possible. Once again, that is star one if you wish to ask a question. And your first question comes from the line of Stacey Q from TD Cohen. Your line is open.

Thanks so much for taking our questions. So we wanted to ask a few more questions on the restructuring process. Is it based on what you're seeing in Q3, Q4, or are you signaling confidence in your competitive positioning for AUR200? So just help us understand the PSS that you saw in Q3, your view on the patient restarts and hospital capture, what's the growth driver in the future, and then the reason for the restructuring. So that's the first question. And then for follow-up, for AUR200, Can you just talk about what exactly you plan to disclose after the phase one single sending dose and what kind of disclosures you might expect? Thanks so much.

Stacey, first off, thank you. And there were multiple questions in there. So why don't I try to dissect them one at a time. And then if I miss on any of them, please come back to me. The first is on the restructuring. So over the last, let's call it 60 to 90 days, we've taken a very aggressive review of the primary drivers of our business, focus of the organization, and the things that we believe are driving growth and value for the organization intrinsically and, of course, hopefully accruing over time to the share price. And by that, I think we were able to really do a – a lot of work that we're able to point us in the direction of what those drivers would be. So this is in no way signaling that we don't have confidence in the business. We're confirming 2024 guidance. We're not giving 2025 guidance today, but this should in no way be interpreted as a slowing down of the growth. We actually think by this focusing, we can continue to grow the compound at the rate we've seen or even better. Moving forward, if you look at the PSFs question, you know, I think at least our interpretation internally is PSFs have moved from where we were in quarter three last year just having PSFs to today it being a combination of PSFs, product coming out of the hospital, which we try to interpret to a patient, but we have ships in most cases that are going into the hospital. And then the restarts in our business. And those three in combination, along with strong persistency that we've driven from the follow-up Aurora trials, the three-year data that we had through Aurora, are all helping to continue to drive the compound. So we're not de-emphasizing PSFs, but I think you need to look in total at the PSFs in combination with restarts in our business, which are growing every quarter more and more, and the hospital-based business. And, you know, since that number did become reflected in Q4 last year, we'll be able to give like-to-like growth numbers of both PSFs, hospitals, and restarts Q4 to Q4 when we report the fourth quarter. Your last question was on AUR200 and what we expect to... to actually present as we move in. We'll have the single ascending dose and the multi-ascending dose trials that we're working on reading out next year. Obviously, there'll be the pharmacokinetic profile of the drug that we'll get from that. And of course, any relevant biomarker work that you would expect to see coming out of those trials.

Thank you so much.

Thanks, Stacey.

Your next question comes to the line of Maury Graycroft from Jefferies. Your line is open.

Hi, good morning. Congrats on the progress and thanks for taking my question. Maybe just starting with thinking about fourth quarter. Typically you guys have a heavier fourth quarter in sales. And if you maintain the current run rate, you should be able to hit the midpoint of your guidance comfortably. So we're just wondering what you're seeing so far in October and And if the higher end of guidance is potentially conservative, if you can comment on that.

Yeah, I wouldn't overread into us maintaining the guidance range that we have right now. We feel comfortable with the range that we've put out there. And at this stage, we did bat around whether, you know, we change or narrow that range. And we thought it was just a more conservative approach. to look at the fourth quarter. The good thing is it lands us right in that guidance range. And if you're looking for anything to point out what might put you on the low end versus the high end, obviously, you know, you have a lot of patients with the year-end insurance changes, et cetera, that kind of moves into the first quarter as well that we'll always work through in the month of December. And you have holidays in November and December. So we wanted to just make sure that we accounted for those as potential factors as well. But you're not incorrect on the historical.

We've seen growth 3Q over 4Q. Got it. That's helpful. And just wondering how the observational registry study, the ENLIGHT-LN study, is providing insights into the real-world lupus enterprise treatment paradigm and how lupkinase is used. And you continue to get a nice uptake in patients restarting leukinus. Are you getting insights into how the segment is defined and if you can potentially influence and ramp up this effect going forward?

Yeah, I'm going to turn some of this over to Dr. Greg Keenan, who's here with us, who is our chief medical officer and heading up our R&D efforts. But One we had, one of our first presentations is actual data at this year's ASN. He can talk to you more about that. And I think the, you know, the restart dynamic, which I welcome Dr. Keenan's commentary on as well. I think we've learned that this restart phenomenon is kind of how the disease is treated. And today, not directed by guidelines, but actual physician practice, like they put a patient on drug, they get UPCR down to an acceptable level. And many times a physician is then taking the patient off of the drug, not just our drug, any medication that they might be on. If UPCR flares, then they're putting them back on drug. And, you know, whether you look at ULAR or the Cadego guidelines that were recently just updated, or we've got the impending ACR guidelines that we're hoping to get an eye on at this year's ACR meeting, I think the consistency of putting patients on drug, treating aggressively at early signs of UPC, of elevated proteinuria in the urine, and keeping patients on drug for three to five years and not doing these treating flares is going to be absolutely consistent, at least our prediction. We see that as a great opportunity as the market moves forward that will, of course, affect restarts, but will also have a very positive impact on things like persistency. So we think there's wind in our sails on both fronts at this stage and why we see the importance of, growing importance of hospital-based sales and restarts. Greg, on the light LN registry, what would you add there?

I just, we're starting to gain insight in the real world as to who's receiving this treatment, and importantly, a larger proportion than typically is observed in clinical trials we see of African Americans that are receiving the treatment. Most recent data cut was over 35% of the participants are African American or Black. And then the other thing that we do observe is different combinations of treatments along with luteinus. We're starting to see at least a little bit of combinations with Benlista and just a few with anaphralomab. So we think over time we'll gain more insight as to how people are using luteinus in the real world. For now, we're pleased with the number of patients we have and the success of the registry.

Got it. All helpful perspective. Thanks for taking our questions. Thank you, sir.

Your next question comes from Olivia from . Your line is open.

Hi. Good morning. Thank you for the questions. You guys have shown some really nice potency data for AUR200. So how are you thinking about the potential dose levels that you want to test in the clinic? You know, I guess what I'm getting at is we've seen in this class that higher doses can have some safety or tolerability issues. but I'd also think that you guys could probably test lower doses with a higher potency drug. So just any comments on how you're thinking about doses and balancing efficacy with safety would be helpful. And then in terms of administration, it is a subcutaneous regimen. So is it fair to assume that you're looking to develop an at-home administration product?

Olivia, I think the bottom line, and I'll take this question. Greg, is we're in the single ascending dose and multi-ascending dose studies now, or we'll be moving into the multi-ascending dose trial. And these are, they're all great questions. They're all things we're going to figure out in human beings in these studies. So we look forward to reporting them to you as we get data.

Okay. Understood. Thanks, Peter.

Thank you. Your next question comes from the line of Will Suckkin from Lyrinc Partners. Your line is open.

Great. Hey, guys. Thanks for taking our question here. We just have two quick ones. First on Leukinus, can you just provide a bit more color commentary on the environment in the third quarter? We can appreciate that sales remain pretty strong, but the regression in PSFs was a bit more acute than we've seen before just comparing to last year. And then on AUR200, there's been a lot of buzz in the anti-April space. with yet another asset entering the ring last week. So, can you just remind us how you're thinking about competitive differentiation and what indications you might be thinking about? Thank you.

Yeah, I'll answer the last one first. Let us actually get the data from the SADMAD studies and, you know, see what they tell us before we come forward and tell you what indications we're trying to target, et cetera. We've got to get some human clinical data here, so I'm not trying to in any way dodge the question. I think we've got to get smart once we see these trials and then move in the direction of the indications we want to go after. So more to come. On your first question, which centered on PSFs, as I said previously, yeah, I mean, 3Q, we always have a summer dynamic, but I don't want to dig too much into that because I do think there was a little bit of that More and more, we are seeing the combination of PSS alongside of restarts and the hospital business as being the best way to look at that, coupled, of course, with what our patient retention looks like, you know, on a 12-month, 24-month, et cetera, basis is the best way to predict where revenue is going for the company. So, you know, gosh, our consistency, if you just kind of regress the business from launch to where it is today, is getting more and more predictive after four years of the drug being on the market and moving into our fifth year. So not in any way trying to say that PSFs aren't important. They are. They're when new patients are starting drug according to our process. But understand, patients start outside of our process too, and that's restarts and in the hospital setting where they're not using our process. And if you look at those in combination, the growth quarter over quarter was robust. And as I said, Q4, when we report it, we'll actually be able to show you like numbers on Q4 last year for PSFs, Q4 for hospital starts, and Q4 for new patient restarts, and those in combination are where we're moving to really start looking at, in aggregate, the new patients getting on drug within the quarter.

Great.

Thank you for that commentary. There are no further questions at this time, so I would like to hand back to Peter Green, the CEO, for closing remarks.

Thank you, operator, and thank you, everyone, for joining the call today. We look forward to continuing to report our progress as we continue to move the business forward and build the business for the long term. Thank you very much for your time.

That does conclude our conference for today. Thank you for participating. You may now all disconnect.