Earnings Call Transcript - AUPH Q2 2024

Operator, Operator

Good day, everyone. Welcome to the Aurinia Pharmaceuticals Second Quarter 2024 Earnings Call. As a reminder, this conference is being recorded. I will now hand over the call to your host, Andrea Christopher, Head of Corporate Communications and Investor Relations for Aurinia Pharmaceuticals. Thank you. You may begin.

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 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 second 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 US 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 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 US Securities and Exchange Commission and Canadian securities authorities. Please note that all statements made during today's call are current as of today, Thursday, August 1, 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, CEO

Thanks, Andrea, and good morning, everyone. I want to thank everybody for joining us on today's call. On this morning's call, we will focus on the company's second quarter performance. I'll then turn the call over to Dr. Greg Keenan, our Chief Medical Officer, to give an update on our medical work across the business, including the development of our pipeline asset AUR200. Greg will be followed by Joe Miller, our CFO, to provide additional details on our financial results and highlights. Now let me provide some details on our second quarter business metrics and how we're preparing for the rest of the year. With the continued focus on commercial execution and accelerating the company's operations towards cash flow positivity, we achieved a strong second quarter performance. For the second quarter of 2024, Aurinia achieved $57.2 million in total net revenue. This is versus $41.5 million in revenue for the same periods in 2023, representing growth of approximately 38%. Year to date, total net revenue was $107.5 million for the six months ended June 30, 2024, as compared to $75.9 million for the same period in 2023, representing growth of approximately 42%. Net product revenue, consisting of loop kinase and voclosporin product sales was $55 million for the three months ended June 30, 2024, and $41.1 million for the same period in 2023. This represents growth of approximately 34%. Net product revenue was $103.1 million for the six months ended June 30, 2024, and $75.4 million for the same period in 2023, representing growth of approximately 37%. We also achieved approximately $15.8 million in positive free cash flow in the second quarter, ahead of our initial projections, which further strengthens our financial position and provides more flexibility to engage in business building activities for the future. The company had cash, cash equivalents, and restricted cash and investments of $330.7 million as of June 30, 2024. In terms of commercial performance metrics, we added 428 patient start forms and approximately 127 new patients who are either restarting loop kinase or receiving it through a hospital pharmacy. Together, these total approximately 555 PSS in combination with restarts and hospital fills as compared to 451 PSS in the prior year second quarter, representing substantial year-over-year growth. We also achieved 22% growth in total patients under kinase therapy with approximately 2,336 patients on therapy as of June 30, 2024, as compared to 1,911 patients as of June 30 of 2023. The significant year-over-year growth was driven by increased new starts. Patients restarting loop kinase after being off therapy for an extended period of time are hospital fills and improving persistency rates year over year. From April 1, 2024, through July 31, 2024, we added approximately 538 PSS and approximately 155 new patients from restarts in the hospital channel. We continued to sustain a high conversion rate in the quarter with approximately 85% of PSS converting to patients on therapy. We also sustained a rapid conversion time with approximately 60% of patients starting therapy within 20 days. Our overall adherence rate remained high at 88% through the second quarter, and we continued to achieve strong persistency with approximately 56% of patients remaining on therapy at 12 months. Additionally, in the second quarter, 51% and 46% of patients remained on therapy at 15 months and 18 months respectively. So in summary, we believe our second quarter accomplishments reflect solid execution against our previously announced business priorities. Based on this, we're narrowing our full-year net product revenue guidance range to a range of $210 million to $220 million from the previously established guidance range of $200 million to $220 million. Looking forward to the second half of the year, we have several innovative commercial initiatives planned as well as some upcoming key milestones. Importantly, as one example of these initiatives, Aurinia is launching a new marketing campaign that reinforces the company's commercial strategy to accelerate market growth by encouraging rheumatologists to prescribe loop kinase and do it earlier in the lupus nephritis treatment paradigm and to maintain that therapy for at least three years in accordance with current treatment guidelines. This innovative and eye-catching campaign highlights the importance of prescribing loop kinase as part of the foundation therapy to treat lupus nephritis from the start to reduce the risk of irreversible kidney damage caused by proteinuria. Our commercial activities outside the US continue to grow. Otsuka's launch efforts in Europe are generating meaningful collaboration revenues. And we are also working diligently with Otsuka to seek approval for loop kinase in Japan. Recall that Otsuka filed a JNDA with the Japanese regulatory authorities in November of 2023 for the hopeful approval of loop kinase to treat adults with lupus nephritis. And we anticipate a response in the second half of this year on that filing. Upon approval, we expect to receive a milestone payment from Otsuka for $10 million as well as low double-digit royalties on net sales once loop kinase is launched in Japan. In terms of our pipeline, we're excited to let you know that we continue to progress AUR200 into the clinic. And importantly, we anticipate funding the development of AUR200 with available cash flow that will not impact previously announced post-restructuring operating expense targets. And as a reminder, we expect to recognize $50 million to $55 million in annual cost savings following the restructuring with approximately 75% of that will be recognized in 2024. So with that, I'd now like to turn the call over to Dr. Greg Keenan, our Chief Medical Officer, for a more in-depth discussion on our medical affairs strategy in greater detail on our near-term AUR200 development strategy. Greg will be followed by Joe Miller, our CFO, for a more detailed review of our financial results. Of course, I'll then return to the end of the call for a quick recap and then to open up the mic in order to have you ask your questions. So with that, let me turn it over to Dr. Keenan. Greg?

Greg Keenan, Chief Medical Officer

Thanks, Peter. And good morning, everyone. I'd like to take a few minutes to provide you with an overview of our medical and scientific efforts as it pertains to loop kinase and our AUR200 development plans. Our medical affairs strategy is focused on important scientific engagements with the lupus nephritis treating community. In the second quarter, our medical affairs team had approximately 180 interactions with the top 30 experts in lupus nephritis. In the first half of the year, we had over 1,200 engagements with both rheumatologists and nephrologists. Collectively, these discussions are focused on strategies to identify appropriate LN patients for whom loop kinase should be considered and understanding the clinical attributes of loop kinase that make it an optimal therapy in the management of LN. Additionally, across more than 70 sites participating in the registry, we've enrolled 32 patients this quarter and are ahead of our goal to fully enroll the registry by the end of next year. This is a registry that monitors important outcome measures and safety events amongst LN patients taking loop kinase and receiving care in US community and academic practices. We've submitted an abstract to a major academic society for their fall meeting, which will provide the first view of the diverse demographics of loop kinase patients. Our medical team attended key meetings in the US, including CCR East and NKF, as well as 38 additional regional and international symposia and medical society meetings in the quarter. Notably, at both ERA and ULR, an analysis of the clinical value of loop kinase in combination with MMF and low-dose steroids versus MMF and steroids alone was delivered in oral sessions. Four manuscripts were published this quarter as well, including a loop kinase cost-effectiveness model as well as preclinical work, demonstrating differences in lipid metabolism and electrolyte metabolism relative to first-generation CNIs. As Peter mentioned, we are also moving forward with AUR200, our potential next-generation therapy for autoimmune disease. It's a highly potent and specific immune modulator targeting BAFF and April. AUR200 is an IgG4 Fc fusion protein containing a structurally engineered B cell maturation antigen, BCMA domain. There is no appreciable effector function on this molecule. AUR200 binds and neutralizes BAFF and April, thus affecting B cell survival and maturation, resulting in a decrease in B cell populations and immunoglobulins. We believe AUR200 has the potential to serve as a best-in-class treatment in diseases with high unmet need. We intend to develop it in disease areas where there are few current market entrants. Our overall development strategy for AUR200 includes exploring one larger indication and one fast-market smaller indication that meets the FDA criteria for orphan and rare diseases. We expect to have first patients entering our Phase one single ascending dose study of AUR200 in the third quarter of this year. We anticipate having data available from the SAD study in the first half of 2025, which will inform our subsequent development program. Deliverables from our SAD program will include data on safety, tolerability, pharmacokinetics and biomarkers. We're excited to move forward with this high-potential differentiated molecule that could make a significant impact earlier in the treatment algorithm in numerous autoimmune diseases with high unmet need. I'll now turn the call over to Joe Miller. Joe?

Joe Miller, CFO

Thank you, Greg, and good morning, everyone. Let's take a few minutes and go into detail regarding our financial results for the second quarter and six months ended June 30, 2024. As of June 30, 2024, we had cash, cash equivalents, restricted cash and investments of $330.7 million compared to $350.7 million at December 31, 2023, and $320.1 million at the end of Q1 2024. The decrease from year-end cash, cash equivalents, restricted cash and investments is primarily related to the continued investment in commercialization activities and post-approval commitments of the kinase, model plan payments, share repurchases and restructuring-related payments, partially offset by an increase in cash receipts from sales of loop kinase and cash payments from Otsuka. Through July 31, Aurinia had repurchased 3.4 million shares for approximately $18.6 million at an average cost of $5.36. As Peter mentioned, our free cash flow in the second quarter of 2024 was approximately $15.8 million ahead of initial projections and demonstrated the positive impact of the restructuring efforts the company undertook in first quarter of 2024. Total net revenue was $57.2 million for the quarter ended June 30, 2024, and $41.5 million for the same period in 2023, representing growth of approximately 38%. Year to date, net revenue was $107.5 million for the six months ended June 30, 2024 compared to $75.9 million for the same period in 2023, representing growth of approximately 42%. Net product revenue consisting of loop kinase, voclosporin product sales was $55 million for the quarter ended June 30, 2024, and $41.1 million for the same period in 2023, representing growth of approximately 34%. Net product revenue was $103.1 million for the six months ended June 30, 2024 and $75.4 million for the same period in 2023, representing growth of approximately 37%. The increase is primarily due to an increase in sales of kinase to our two main specialty pharmacies driven predominantly by further penetration into the market. Additionally, we had sales of semi-finished product to Otsuka as they continue to commercialize in the Otsuka territories and prepare for approval launch in Japan. License collaboration and royalty revenue was $2.2 million and $394,000 for the quarters ended June 30, 2024 and June 30, 2023. License collaboration royalty revenue was $4.4 million and $466,000 for the six months ended June 30, 2024 and June 30, 2023. The increase is primarily due to manufacturing service revenue from Otsuka related to shared capacity services that commenced in late June of 2023. Total cost of sales and operating expenses, inclusive of restructuring costs in the second quarter of 2024 were $58.7 million and $57.7 million for the quarters ended June 30, 2024 and June 30, 2023. Total cost of sales and operating expenses, inclusive of restructuring costs in the first half of 2024 were $122.3 million and $121.7 million for the six months ended June 30, 2024 and June 30, 2023. Let me now give you a further breakdown of operating expenses, drivers and fluctuations. Loss of sales were $8.9 million and $1.6 million for the quarters ended June 30, 2024 and June 30, 2023, cost of sales were $16.7 million and $2 million for the six months ended June 30, 2024 and June 30, 2023. The increase is primarily due to the amortization of the MultiPlan finance right-of-use asset, which was placed into service in late June of 2023. Semi-finished product sales to Otsuka and increased sales of kinase. Gross margin was approximately 84% and 96% for the quarters ended June 30, 2024 and June 30, 2023. Gross margin was approximately 85% and 97% for the six months ended June 30, 2024 and June 30, 2023. Gross margin for the quarter and full year of 2024 were negatively impacted by the amortization of the mono plant and lower margin sales of semi-finished product to Otsuka for distribution in Europe in anticipation of product approval in Japan. SG&A expenses inclusive of share-based compensation were $44.9 million and $47.1 million for the quarters ended June 30, 2024 and June 30, 2023. SG&A expenses inclusive of share-based compensation were $92.6 million and $97.2 million for the six months ended June 30, 2024 and June 30, 2023. The primary driver for the decrease were lower employee and overhead costs due to a reduction in general and administrative headcount, which occurred late in the first quarter of 2024, partially offset by an increase in legal fees. Non-cash SG&A share-based compensation expense included with SG&A expenses was $8.1 million and $9.8 million for the quarters ended June 30, 2024 and June 30, 2023. Non-cash SG&A share-based compensation expense included within SG&A expenses was $15.6 million and $17.4 million for the six months ended June 30, 2024, and June 30, 2023. R&D expenses, inclusive of share-based compensation expense were $4.1 million and $12.7 million for the quarter ended June 30, 2024 and June 30, 2023. R&D expenses, inclusive of share-based compensation expense were $9.6 million and $25.8 million for the six months ended June 30, 2024 and June 30, 2023. The primary drivers for the decrease were lower employee costs due to a reduction in head count, which occurred late in the first quarter of 2024, a decrease of CRO and development expenses related to ceasing development of our AUR300 program and timing of expenses related to AUR200. Non-cash R&D share-based compensation expense included within R&D expense was $87,000 and $2.1 million for the quarters ended June 30, 2024 and June 30, 2023. Non-cash R&D share-based compensation expense included within R&D expense was a $2.1 million credit and a $3.7 million expense for the six months ended June 30, 2024 and June 30, 2023. The non-cash R&D share-based compensation credit in the six months ended June 30, 2024 is due to the reversals of expense for forfeitures related to a reduction in headcount, which occurred in the first quarter of 2024. Restructuring expenses were approximately $1.1 million ended zero for the quarters ended June 30, 2024 and June 30, 2023. Restructuring expenses were approximately $7.8 million and zero for the six months ended June 30, 2024 and June 30, 2023. Restructuring expenses primarily included employee severance, one-time benefit payments and contract termination expenses. The company does not expect to incur additional material restructuring-related expenses going forward. Other income net was $290,000 and $3.6 million for the quarters ended June 30, 2024 and June 30, 2023. Other income net was $4.4 million and $3.3 million for the six months ended June 30, 2024 and June 30, 2023. The changes were primarily driven by changes in the fair value assumptions related to our deferred compensation liability and the foreign exchange remeasurement of the mono plant lease liability which commenced in June 2023 and is denominated in Swiss franc. Interest income was $4.2 million and $4.1 million for the quarters ended June 30, 2024 and June 30, 2023. Interest income was $8.7 million and $7.9 million for the six months ended June 30, 2024 and June 30, 2023. Interest expense was $1.2 million and $65,000 for the quarters ended June 30, 2024 and June 30, 2023. Interest expense was $2.5 million and $65,000 for the six months ended June 30, 2024 and June 30, 2023. The interest expenses related to the amortization of our model plan financing lease. For the quarters ended June 30, 2024, Aurinia recorded net income of $722,000 or $0.01 net income per common share as compared to a net loss of $11.5 million or $0.08 net loss per common share for the quarter ended June 30, 2023. For the six months ended June 30, 2024, Aurinia recorded a net loss of $10 million or $0.07 net loss per common share as compared to a net loss of $37.7 million or $0.26 net loss per common share for the six months ended June 30, 2023. With that, I'd like to hand the call back over to Peter for some closing remarks. Peter?

Peter Greenleaf, CEO

Thank you, Joe. We're looking forward to continued robust performance in the second half of 2024, including solid commercial execution, advancing AUR200 into the clinic with first patients dosed and a strong balance sheet with cash flow generation. I want to thank you all for your time today, and we'll now open the lines for any questions you might have. Operator?

Operator, Operator

Your first question comes from Maury Raycroft with Jefferies.

Unidentified Analyst, Analyst

Hey, good morning. This is Farzana on for Maury. Thank you for taking my call. So the growth in PFS and patient restarts in 2Q came in a bit lower than expected. And then this month is also looking slightly lean. How should we expect about the cadence in the summer months, given the typical seasonal impacts you have seen in the past and how does that factor into your adjusted guidance?

Peter Greenleaf, CEO

Thank you for the question. The straightforward answer is that the quarterly performance from Q1 to Q2 and the trend moving forward are consistent year-over-year, with growth overall. Although you noted that the weekly run rate of new patients from Q1 to Q2 is slightly down, this aligns with past trends during the summer months. When examining the year-over-year trend, we are seeing improvements across all metrics for Q1, Q2, and the weekly run rate as we head into Q3. It's crucial for us to continue increasing new patients, and we remain focused on that. We aim to see continued growth in PSF and in the hospital channel, as well as steady growth in patient restarts. Overall, the numbers are still growing year-over-year, even if your observation is valid.

Unidentified Analyst, Analyst

All right, that makes sense. You added the free cash flow positivity and have a strong balance sheet. So wondering should we expect any potential in-licensing or assets at other companies?

Peter Greenleaf, CEO

Yeah, I think there's the obvious observation that we, barring AUR200, which has moved into the clinic, we are a single-product company. As we've said on other calls, we think it's important strategically to continue to diversify our pipeline and, of course, be open to commercial opportunities as well. But our priority has been more focused on later-stage pipeline, but your observation that our balance sheet and the need for diversification is there and as a company strategically, we continue to work on that.

Unidentified Analyst, Analyst

Got it. Thank you for taking the question.

Operator, Operator

Your next question comes from Joseph Schwartz with Leerink Partners.

Joseph Schwartz, Analyst

Thanks a lot. I was going to ask something on the kinase and then also on AUR200. So I guess as we've discussed before, there seems to be an area of significant upside if the overall LN market embraces more regular urine screening. I was wondering if you could help us understand how much success you've had influencing this behavior and how we should think about your ability to move the needle going forward? Do you have a strong understanding of which practices are not doing this and how effective can you be targeting such sites with your MSLs to educate physicians and encourage more identification of patients that might benefit from the kinase?

Peter Greenleaf, CEO

So three-point answer to the question, Joe. One is on our Aurinia's studies that we do attitude and awareness studies that we do on a quarterly basis. It's clear that both rheumatologists, which by the way, is the primary mover on this one, because rheumatologists are going to be the ones seeing an SLE patient and doing the initial diagnosis in the urine screen awareness is up significantly since we've been talking about this. Now we juxtapose that with the guidelines saying the need for urine screens on every visit of an SLE patient, but that awareness is up. Second, we pull on data on actual hearing screen analysis that's done and we don't target it down to directly the office. We just look at an aggregate to see if the urine screening is up. We have not seen massive increases now, albeit we're moving into the summer time period. So I think we need to continue to monitor this over time, but that awareness has not translated into a higher rate of diagnosis yet. The positive momentum is that awareness is higher. Your question around targeting? Yeah, I think we have a very good understanding of who the high prescribers are and who the high target rheumatologists are with a high number of lupus patients. A part of our plan is to call on both with our MSLs and with our sales representatives to call on those target accounts. The last point I will make is obviously I mentioned in the call that we've launched a new campaign initiative across the business and that campaign initiative is exclusively targeted towards the point that you bring up, that there's a link between what the aspirations and the goals of therapy are and how actual practice is happening from diagnosis through to treatment. And we think once that can catch up, there's significant growth for the market. So our new campaign is all centered around that. So there's positive momentum; we haven't seen it actually materialize yet, but we feel good about the message, at least sticking with physicians.

Joseph Schwartz, Analyst

Thanks. That's helpful. And then can you talk about your decision to bring AUR200 forward again? Is this driven by the strategic interest in this space? Can you talk about how the preclinical data for this agent compares to the many assets in late-stage development? And what indications are you thinking about pursuing?

Peter Greenleaf, CEO

Yeah. So as we've said all along, our restructuring efforts were to, first, bring the company into a more optimized phase, knowing that both we had AUR200, we also had AUR300 alongside of it. We knew that AUR300 we had to take back to form of reformulation. So we exited that asset, and by doing so, we had the ability to cut a significant amount of our operating expense. On AUR200, we said, well, we'll do a market check as well as keep moving the product forward and determine after doing a market check whether to partner it, but whether we should take it forward on our own. While we had interest, it was our determination, one based upon how those potential conversations went, and two, based on the excitement in this space. We've always been excited about the possibility of B-cell inhibition for BAFF and APRIL, and that pathway, and we made the decision to take it forward on our own and did it in a way where we're not changing our '24 operating expense guidance and what we've given in terms of our estimates for operating free cash flow for the year. The last two questions were centered around any data of our Tier two. Greg can talk about that in a second. But on the indication front, I'll oversimplify to say we're going to try to, as Greg said, target an area that might be under orphan designation and alongside that to try to target a much larger area, that would not be in the IDN space. Not that we don't think the product could work, but obviously IDN has been the primary focus of other APRIL/BAFF inhibitors who are further ahead of us. On the differentiation side, let me give Greg a moment to just talk a little bit about what we've seen to date with the compound.

Greg Keenan, Chief Medical Officer

Sure. So thanks, Peter. With some preclinical work that we've done, we've been able to make some comparisons relative to some of the earlier BAFF/APRIL inhibitors, namely Telitacicept. We find that from our work, we have a more potent compound in an equivalent milligram amount of drug. We think that is going to be a favorable attribute for AUR200 as we advance the development. We don't have those comparisons for Tazocept. Relative to how this particular strategy fits compared to other B-cell inhibitors and depleters, we think that given the presumed efficacy of our reductions in B cells and reductions in quantitative immunoglobulins, we expect to see against the backdrop of perhaps maintaining the ability to respond, we believe that this efficacy and safety profile will be favorable compared to other B-cell depleting strategies. Hence, we think it will be a very useful agent in many B-cell-driven diseases.

Joseph Schwartz, Analyst

Thanks for all the color.

Peter Greenleaf, CEO

Thanks, Joe.

Operator, Operator

Your next question comes from Stacy Ku with TD Cowen.

Stacy Ku, Analyst

Thank you for taking my questions. I wanted to revisit the hospital channel we discussed previously. I understand it's still early, but could you provide insights on how you expect it to develop over this year and in the coming years? The patient restarts and additions to the hospital channel appear to be crucial as we look ahead. Additionally, could you share some metrics regarding these patient restarts? Specifically, what is the average duration of treatment prior to a restart? Is it typically over 12 months, and how are you managing to bring these patients back? Are they experiencing relapses? How do you convert them into a more chronic therapy? Lastly, I’d like your perspective on the long-term outlook and the competitive landscape. We anticipate Roche's product will have its Phase three readout this summer, so I'm interested in your thoughts on that. Thank you.

Peter Greenleaf, CEO

Yeah. Making sure I have all these. Let me start first on the hospital channel. Because we haven't broken these out, let me give a little bit more direction on kind of how these have rolled through. I think right now, the smaller of the two numbers in terms of restarts in the hospital channel has clearly been the hospital channel, we've talked about that. I wouldn't say we have enough to really trend it out yet, Stacy, but we are seeing growth in the tens of patients, call it, 10 to 20 patients, 30 patients a quarter, and my hope would be that continues and we start to see this be a significant growth element per quarter, moving from a couple of 10 patients per Q to more than that. But we'll have to see how it trends. We're excited about it. It has moved from almost being just onesies to now being as high as 30, 40, 50 patients a quarter. And on a base of, 400 patients to 500 patients to 600 patients per quarter of new patients, 10% to 20% of that base is coming from the hospital channel. Our hope would be that that's going to continue to grow, and everything points to that. On the average in terms of restarts, they have to be off therapy for at least four months. I don't think I have that at my hands of those restarts, but for us to know that they fall out of our system and they become a restart when they've been off therapy for at least four months. Your last question on competition, obviously, lots of folks are targeting the LN space and more importantly, targeting it as a precursor towards lupus, especially with the B-cell therapies. The most recent activity updates that you're referring to are both on SAPHNELO and Roche's product Gazyva. Both, as I understand from what they've reported, Roche hopes to have data soon, hopes to file this year, potentially having their market data positive as soon as next year. And then SAPHNELO is more protracted. We start with SAPHNELO, obviously they ran a Phase two study that study did not show a statistically significant difference in terms of reduction in proteinuria, but they did move forward with the Phase three. So we'll see, and that's a couple of years off. Both are targeting B-cells. So it's our belief that much like Benlysta, the data will probably work, but they'll probably have a more protracted impact in terms of if their impact on reducing proteinuria to the levels that the guidelines are calling for, where the guidelines are targeting three month, six month, one year reductions in proteinuria. And so far, we've not seen B-cell inhibition be able to hit the target levels at those early stages. Now at two years, they seem to work about as well as we do, and these have not been cross-compared obviously. But in this study, data for each individual agent appear to show that they work, they work about as well as we do at a year at two years. These patients have a serious complication of their disease. They can't wait for two years. So we think our positioning, based upon the rapidity of response and magnitude of response early puts us at a competitive advantage even though the studies haven't been cross-compared. Greg, what did I miss?

Greg Keenan, Chief Medical Officer

No. I think you're spot on. The punchline is there's definitely a role for loop kinase in many of these scenarios that work very, very quickly. These B-cell depleting agents just take that much longer. That's something clinicians need to be mindful of.

Peter Greenleaf, CEO

Other modalities, we haven't seen any new interest and or information on and seem to be well off in that time period. The two big ones coming soon are larger companies. Hopefully, one of these larger companies will also start to focus on educating doctors and patients in the LN market and help us with the expansion and the market development work that we're doing. They obviously have more resources and more dollars to do that.

Stacy Ku, Analyst

Okay. That's really helpful. Thank you so much.

Peter Greenleaf, CEO

Thanks, Stacy.

Operator, Operator

Your next question comes from Ed Arce with H.C. Wainwright.

Ed Arce, Analyst

Thank you for taking my questions, and congratulations on the quarter. I have a few inquiries. First, I would like to clarify the PSF and hospital restart numbers, which have both shown a sequential decline. Considering the usual annual seasonality of the first quarter, which often experiences a slight drop due to the insurance restart, could you elaborate on the seasonality between the first and second quarters and how this relates to your revised guidance range for the year? Additionally, regarding your income statement and the restructuring costs, I know you initially projected between $11 million and $15 million, but it seems you have incurred less than that so far. Can you confirm whether there will be any additional charges in the third quarter? Finally, could you provide a summary of the share buybacks for the quarter, including the number of shares and the total amount spent? I have a follow-up after this.

Peter Greenleaf, CEO

Okay. I will let Joe address both the P&L and the impact on the income statement regarding the questions that were asked. Regarding the PSF hospital situation and the transition from 1Q to 2Q in relation to our guidance for the year, I want to emphasize that there is a consistent pattern in the business trends we've observed from 1Q to 2Q. We still view this as a qualitative impact due to reduced patient and doctor activity during the summer months, which makes sense given our relatively young patient demographic that has remained stable since we launched the product. The trends we are experiencing this year align with historical patterns and show year-over-year growth, although we recognize that we would prefer to see even greater increases. Concerning our guidance for the year, we have reported approximately $107 million so far. To reach the low end of our previous $200 million guidance, we would need to experience a significant decline in business during the latter half of the year, which we do not anticipate. We expect that even with a slower summer, maintaining consistency will allow us to stay within our guidance range, which gives us confidence based on that assumption. If we perform exceptionally well over the summer, we could reach the higher end of our guidance range, and we may adjust our figures when we report for the third quarter, but we are comfortable with the range we've provided. Regarding the charges, Joe has addressed that in the transcript, but I will mention it again. As for buybacks, we included that information in the transcript as well, and we will reiterate it for you.

Joe Miller, CFO

Thanks for the question, Ed. Yes, so on the restructuring charge, for all intents and purposes, all restructuring activities were completed in the second quarter. So we do not anticipate any further material spend related to the restructuring plan that was announced early in the first quarter. So yes, you're right. We had roughly approximately $8 million of total restructuring and related costs, about $1.1 million of that reflected in Q2, slightly less than our guidance range initially. But we don't expect anything further thereafter. In regard to your second question related to the share repurchase program, I think we disclosed at March 31, that we acquired approximately $2.4 million shares, as of July 31, we have repurchased approximately 3.4 million shares. So roughly in the time between March 31 and July 31, approximately $1 million additional shares have been repurchased.

Ed Arce, Analyst

Great. Fantastic. Then a last question, perhaps this is for Greg, regarding AUR200, you've decided to move forward and I've stated there's an SAD study data readout expected in the first half of next year with safety, tolerability and PK. I'm wondering if you could provide any detail around the biomarker data that you expect to report. Thanks.

Peter Greenleaf, CEO

Thanks for the question. So as you know, BAFF/APRIL inhibitors block the maturation and proliferation of short-lived plasma cells, specifically the ones that are thought to generate the pathologic antibodies that drive disease. So from the standpoint of healthy volunteers, we can get an early impression as to whether or not we'll have an impact on those measures, namely quantitative immunoglobulins. So IgG, IgM, and IgA, we'll be looking to see what percentage relative to baseline as those levels drop over time. Of course, it's only a single dose, and so the impact may be relatively modest, but it will give us an early impression as to whether or not we've got a molecule here that is biologically active. That will be the key set of numbers that we'll be looking at as it relates to biologic activity. The essence of what we're trying to do here is look at those who were ahead of us to and what they've reported on and tried to give as much like-for-like data. So the question that was asked previously around how do you see your molecule sort of mapping towards the others who might be ahead of you? Each one is slightly different. Now, they're hitting these targets. We think even that early biomarker data will have key points of differentiation in both shaping how we move into further clinical development, the indications we go after, and how we should be looking at this compound relative to potential competitors in the APRIL/BAFF space.

Ed Arce, Analyst

Very helpful. Thank you so much.

Peter Greenleaf, CEO

Thanks, Ed.

Operator, Operator

At this time, there are no further questions. I'd like to turn the call back over to our speakers for any further remarks.

Peter Greenleaf, CEO

I have no further remarks. I want to thank everybody for joining us on the call today. We look forward to continuing to keep you updated on our business as we move forward. Thanks for your time, everyone.

Operator, Operator

Thank you, everyone, for attending the Aurinia Pharmaceuticals second quarter 2024 earnings call. Have a wonderful rest of your day.