Earnings Call Transcript - AUPH Q3 2024

Andrea Christopher, Head of Corporate Communications and Investor Relations

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, our Chief Financial Officer; and Dr. Greg Keenan, our Chief Medical Officer. Today, we will review and discuss Aurinia'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 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, 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, Aurinia assumes no obligation to update any such statements. Now let me turn the call over to Aurinia's President and CEO, Peter Greenleaf. Peter?

Peter Greenleaf, President and Chief Executive Officer

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 9 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 9 months of 2024, net product revenue was $158.6 million compared to $116.2 million for the same period in 2023, 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 position. The company had cash, cash equivalents, restricted cash, and investments of $348.7 million as of September 30, 2024. In terms of commercial performance and metrics for the third quarter, we added 364 PSFs and 146 new patients who were either restarting LUPKYNIS or receiving it through the hospital pharmacy. Together, these totaled 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 LUPKYNIS therapy with approximately 2,422 patients on therapy as of September 30, 2024. This compared to 1,939 patients as of September 30, 2023. This significant year-over-year growth was driven by patients restarting LUPKYNIS 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 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 I study of AUR200, our BAFF/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 LUPKYNIS 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 LUPKYNIS is launched in Japan. Our successful partnership with Otsuka has allowed us to bring LUPKYNIS to lupus nephritis patients across Europe and now Japan, where there's a high rate of lupus nephritis. Additionally, there were 5 presentations on LUPKYNIS at the recent American Society of Nephrology Kidney Week meeting. These presentations describe the critical role LUPKYNIS 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 LUPKYNIS, through its 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 LUPKYNIS business that have historically delivered optimal returns while accelerating clinical development of AUR200. We also expect the restructuring to further strengthen our balance sheet. Going forward, our targeted commercial strategy for LUPKYNIS 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 Miller, Chief Financial Officer

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 9 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 LUPKYNIS, milestone payments, share repurchases, and restructuring-related payments, offset by an increase in cash receipts from LUPKYNIS sales and cash payments from Otsuka. The increase in the balance over the prior quarter is due to cash receipts from LUPKYNIS sales and cash payments from Otsuka, partially offset by commercialization activities, milestone payments, and inventory purchases. Cash flow generated by operations was $17 million for the 3 months ended September 30, 2024, compared to $13.3 million in cash flow used for the 3 months ended September 30, 2023. Cash flow generated by operations was $14.3 million for the 9 months ended September 30, 2024, compared to $47.8 million in cash flow used for the 9 months ended September 30, 2023. Total net revenue was $67.8 million for the 3 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 9 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 3 months ended September 30, 2024, and $40.8 million for the same period in 2023. Net product revenue was $158.6 million for the 9 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 LUPKYNIS sales to the company's 2 main specialty pharmacies, driven predominantly by further penetration of the LN market. Additionally, for the 9 months ended September 30, 2024, Aurinia had sales of semi-finished product to Otsuka as they continue to commercialize in their territories. License, collaboration, and royalty revenue was $12.3 million and $13.7 million for the 3 months ended September 30, 2024, and September 30, 2023, respectively, and $16.7 million and $14.2 million for the 9 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 LUPKYNIS 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 June 2023. Cost of sales were $6 million and $6.8 million for the 3 months ended September 30, 2024, and September 30, 2023, and $22.7 million and $8.8 million for the 9 months ended September 30, 2024, and September 30, 2023, respectively. The increase for the 9-month period is primarily due to the amortization of the milestone finance right-of-use asset, which was placed into service in late June 2023 and therefore only partially impacted prior-year results. Gross margin for the 3 months ended September 30, 2024, was 91% compared to 88% for the 3 months ended September 30, 2023. Gross margin for the 9 months ended September 30, 2024, was 87% compared to 93% for the 9 months ended September 30, 2023. SG&A expenses, inclusive of share-based compensation, were $42.4 million and $47.8 million for the 3 months ended September 30, 2024, and September 30, 2023, respectively. SG&A expenses, inclusive of share-based compensation, were $135 million for the 9 months ended September 30, 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 3 months ended September 30, 2024, compared to $13.6 million for the 3 months ended September 30, 2023. R&D expenses inclusive of share-based compensation were $12.7 million and $39.4 million for the 9 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 Aurinia's AUR300 development program, and the timing of expenses related to developing AUR200. For the 3 months ended September 30, 2024, Aurinia 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 3 months ended September 30, 2023. For the 9 months ended September 30, 2024, Aurinia 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 9 months ended September 30, 2023. With that, I'd like to hand the call back over to Peter for some closing remarks.

Peter Greenleaf, President and Chief Executive Officer

Thanks, Joe. We're looking forward to a strong finish for 2024 and heading into 2025 with a highly efficient organization focused on LUPKYNIS growth and advancing AUR200. I want to thank you all for your time today. We'll now open the lines for any questions you might have.

Stacy Ku, Analyst

So I wanted to ask a few more questions on the restructuring. 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 PSF 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 a follow-up, for AUR200, can you just talk about what exactly you plan to disclose after the Phase I single-ascending dose? And what kind of disclosures you might expect?

Peter Greenleaf, President and Chief Executive Officer

Stacy, 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 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 a signal 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, I think at least our interpretation internally is PSFs have moved from where we were in quarter 3 last year, just having PSFs to today 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 3 in combination, along with strong persistency that we've driven from the follow-up AURORA trials, and the 3-year data that we had through AURORA are all helping to continue to drive the compound. So we're not deemphasizing 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 and the hospital-based business. And 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 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.

Maurice Raycroft, Analyst

Congrats on the progress, and thanks for taking my question. Maybe just starting with thinking about the 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 if the higher end of guidance is potentially conservative, if you can comment on that.

Peter Greenleaf, President and Chief Executive Officer

Yes. 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 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 that might put you on the low end versus the high end, obviously, you have a lot of patients with the year-end insurance changes, et cetera, that kind of move 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.

Maurice Raycroft, Analyst

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 nephritis treatment paradigm and how LUPKYNIS is used. And you continue to get a nice uptick in patients restarting LUPKYNIS. Are you getting insights into how the segment is defined and if you can potentially influence and ramp up this effect going forward?

Peter Greenleaf, President and Chief Executive Officer

Yes. 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 of the actual data at this year's ASN, he can talk to you more about that. And I think 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 whether you look at EULAR or the KDIGO guidelines that were recently 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 elevated proteinuria in the urine, and keeping patients on drug for 3 to 5 years and not doing these treating flares is going to be absolutely consistent, at least our prediction. And 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 ENLIGHT-LN registry, what would you add there?

Greg Keenan, Chief Medical Officer

Just we're starting to gain insight into the real world as to who's receiving this treatment. And importantly, a larger proportion than typically observed in clinical trials we see of African-Americans that are receiving the treatment. The most recent data cut showed that 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 LUPKYNIS. We're starting to see at least a little bit of combinations with BENLYSTA and just a few with anifrolumab. So we think over time, we'll gain more insight as to how people are using LUPKYNIS in the real world. For now, we're pleased with the number of patients we have and the success of the registry.

Olivia Brayer, Analyst

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? 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?

Peter Greenleaf, President and Chief Executive Officer

Olivia, I believe the key point is that we are currently conducting single-ascending dose and will soon start multi-ascending dose studies. These are all important questions, and we will address them through our research in humans. We look forward to sharing the findings with you as we collect data.

Will Soghikian, Analyst

We just have two quick ones. First, on LUPKYNIS, can you just provide a bit more color commentary on the environment in the third quarter? We can appreciate that sales remained 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?

Peter Greenleaf, President and Chief Executive Officer

I'll address the last question first. We need to gather data from the SAD/MAD studies before we specify which indications we plan to target. It's essential to obtain some human clinical data here. I'm not avoiding the question, but we need to analyze the trial results before determining our direction. As for your first question about PSFs, there's always a summer dynamic in the third quarter, but I don't want to focus too much on that. We are increasingly observing that combining PSFs with restarts and the hospital business offers the best insight into our revenue outlook. Additionally, monitoring our patient retention over 12-month and 24-month periods is key to predicting revenue growth. Our business's consistency has become more predictable as we move into the fifth year since the drug's launch. PSFs are important, particularly for new patients starting on the drug through our process, but it's also crucial to recognize that some patients begin treatment outside our process, including those getting restarts or being treated in hospitals. When you consider these factors together, we've seen strong growth quarter-over-quarter. In Q4, when we report our figures, we will provide detailed numbers for PSFs, hospital starts, and new patient restarts from both Q4 last year and this year. This will allow us to analyze the total number of new patients starting the drug within the quarter.

Andrea Christopher, Head of Corporate Communications and Investor Relations

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.

Operator, Operator

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