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spk06: Today, ladies and gentlemen, welcome to Aurinia Pharmaceuticals' second quarter 2024 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star, then zero on your telephone keypad. As a reminder, this conference is being recorded. I would like to turn the conference over to your host, Andrea Christopher, Head of Corporate Communications and Investor Relations for Aurinia Pharmaceuticals. Thank you. You may begin.
spk05: Andrea Christopher 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 Arrhenius' 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 Arrhenius' filings with the U.S. Securities and Exchange Commission and Canadian Securities Authorities, which are also available on Arrhenius' website at arrheniapharma.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 ARINIA's future financial results and business, please refer to the disclosures in ARINIA'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, Thursday, August 1st, 2024, unless otherwise noted, and are based upon information currently available to us. Except as required by law, ARINIA assumes no obligation to update any such statements. Now, let me turn the call over to ARINIA's President and CEO, Peter Greenleaf. Peter?
spk08: 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, AUR 200. 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, Arunia achieved $57.2 million in total net revenue. This is versus $41.5 million in revenue for the same period 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 Kynas and Baclosporin product sales, was $55 million for the three months ended June 30th, 2024, and $41.1 million for the same period in 2023. This represents growth of approximately 34%. Net product revenue is $103.1 million for the six months ended June 30th, 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 30th, 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 PSFs in combination with restarts and hospital fills. As compared to 451 PSFs in the prior year second quarter, representing substantial year-over-year growth. We also achieved 22% growth in total patients on loop kinase therapy, with approximately 2,336 patients on therapy as of June 30, 2024, as compared to 1,911 patients as of June 30, 2023. This significant year-over-year growth was driven by increased new starts. patients restarting loop kindness after being off therapy for an extended period of time, our hospital fills, and improving persistency rates year over year. From April 1st, 2024 through July 31st, 2024, we added approximately 538 PSFs and approximately 155 new patients from restarts in the hospital channels. We continued to sustain a high conversion rate in the quarter with approximately 85% of PSFs 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 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 to $220 million, from the previously established guidance range of $200 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, Zirinia 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 U.S. continue to grow. Atsuka's launch efforts in Europe are generating meaningful collaboration revenues, and we are also working diligently with Atsuka to seek approval for lupkinus in Japan. Recall that Otsuka filed a JNDA with the Japanese regulatory authorities in November of 2023 for the hopeful approval of Loopkinus 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 Loopkinus is launched in Japan. In terms of our pipeline, we're excited to let you know that we continue to progress AUR 200 into the clinic. Importantly, we anticipate funding the development of AUR 200 with available cash flow that will not impact previously announced post-restructuring operating expense targets. And as a reminder, we expect to recognize $50 to $55 million in annual cost savings following the restructuring. with approximately 75% of that 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 and greater detail on our near-term AUR 200 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 you 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?
spk04: 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 engagement 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 NLITE 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 amends. amongst LN patients taking lupkinus and receiving care in U.S. 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 lupkinus patients. Our medical team attended key meetings in the U.S., 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 ULAR, an analysis of the clinical value of lupkinase in combination with MMF and low-dose steroids versus MMF and steroids alone were 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 CNI. As Peter's 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 BAF and APRIL. AUR200 is an IgG4 FC fusion protein containing a structurally engineered B-cell maturation antigen, BCMA, domain. There's no appreciable effector function on this molecule. AUR200 binds and neutralizes BAF 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 to 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 this SADD study in the first half of 2025, which will inform our subsequent development program. Deliverables from our SADD 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 immune need. I'll now turn the call over to Joe Miller. Joe?
spk07: 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 Loop Kindness, monoplant payments, share repurchases, and restructuring related payments, partially offset by an increase in cash receipts from Sales of Loop Kindness and cash payments from Otsuka. Through July 31st, ARENIA 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 demonstrating the positive impact of the restructuring efforts the company undertook in the 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 Kindness, Baclospor, and 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 Loop Kindness to our two main specialty pharmacies, driven predominantly by further penetration into the LN market. Additionally, we had sales of semi-finished product to Atsuka as they continue to commercialize in the Atsuka 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 and 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 for Matsuoka related to the share 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. Cost 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 model plan 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 Loop Kindness. 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 monoplant and lower margin sales of semi-finished product to Atsuka for distribution in Europe and 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 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 ed count, which occurred late in the first quarter of 2024, a decrease of CRO and development expenses related to ceasing development of our AUR 300 program, and timing of expenses related to AUR 200. 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 with an 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 and zero for the quarters ended June 30, 2024 and June 30, 2023. Restructuring expense 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 change is primarily driven by changes in the fair value assumptions related to our deferred compensation liability and the foreign exchange remeasurement of the monoplant lease liability which commenced in June 2023 and is denominated in Swiss francs. Interest income was 4.2 million and 4.1 million for the quarters ended June 30th, 2024 and June 30th, 2023. Interest income was 8.7 million and 7.9 million for the six months ended June 30th, 2024 and June 30th, 2023. Interest expense was 1.2 million and 65,000 for the quarters ended June 30th, 2024 and June 30th, 2023. Interest expense was $2.5 million and $65,000 for the six months ended June 30th, 2024 and June 30th, 2023. The interest expense is related to the amortization of our model plan financing lease. With the quarters ended June 30th, 2024, ARINIA recorded net income of $722,000 or one cent net income per common share as compared to a net loss of $11.5 million or eight cents net loss per common share for the quarter ended June 30th, 2023. For the six months ended June 30, 2024, ARINIA 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?
spk08: Thank you, Joe. We're looking forward to a continued robust performance for the second half of 2024, including solid commercial execution, advancing AUR 200 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?
spk06: At this time, we will conduct the question and answer session. If you would like to ask a question, please press star, then the number one on your telephone keypad now, and you will be placed in the queue in the order received. Once again, please press star, then the number one on your telephone keypad now, and you will be placed in the queue in the order received. Your first question comes from Maury Raycroft with Jefferies. Your line is open.
spk01: Hi, good morning. This is Farzinan from Maury. Thank you for taking our questions. So your growth in PSFs and patient restarts in 2Q came in a bit lower than 1Q, and then this month is also looking slightly lean. So how should we expect about the cadence in the summer months, given the typical seasonal impacts you've seen in the past, and how does that factor into your adjusted guidance?
spk08: Thank you for the question. The simple answer is the quarterly performance from Q1 to Q2 and the trend going into, because as we know, we report PSFs up until the date of the call. are consistent year over year, and there's growth year over year, albeit your observation that Q1 to Q2, our weekly run rate on new patients in combination, is slightly down, but that's consistent with what we've seen over the last several years moving into the summer months. But if you look at the trend year over year, we are up on both on all metrics, Q1, Q2, and the run rate going in on a weekly basis into Q3. Last point, there's the obvious. We need to continue to grow new patients. We're not backing away from that. We need to continue to see PSF growth. We need to continue to see the hospital channel grow, and we need to continue to see consistent growth out of our patient restarts. But the numbers are year over year still growing, albeit your observation is, in fact, right.
spk01: That makes sense. You achieved the free cash flow positivity and have a strong balance sheet. So wondering, should we expect any potential in-licensing assets or other BD options?
spk08: Yeah, I think there's the obvious observation that we, barring AUR200, which is in the process of moving into the clinic, that we are a single product company. And 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 um later stage pipeline but but your observation that that our balance sheet and the need for diversification is there and as a company strategically we continue to work on that got it thank you for taking a question your next question comes from joseph schwartz with lear link partners your line is open hi thanks a lot um i was uh going to ask something on the kindness and then also on aur 200 so
spk03: I guess as we've discussed before, there seems to be an area of significant upside. If the overall Ellen 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 Leptinib?
spk08: So three-point answer to the question, Joe. One is through our awareness studies that we do, our 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 talking to it, meaning educating physicians on the guidelines with the guidelines saying the need to do urine screens on every visit of an SLE patient. But that awareness is up. Second, we pull data on actual urine 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 urine screening is up. We have not seen massive increases. Now, albeit we're in the summer, we're moving into the summertime period, so I think we need to continue to monitor this over time. But that awareness has not translated into a higher rate of diagnosing yet. But the positive momentum is 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. And 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 this key 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 positive momentum. Haven't seen it actually materialize yet, but feeling good about the message at least sticking with physicians.
spk03: 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?
spk08: 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 AUR 200, we also had AUR 300 alongside of it. We knew that AUR 300, we had to take back to reformulation, so we exited that asset and by doing so, we had the ability to cut a significant amount of our operating expense. On AUR 200, we said, well, we'll do a market check as well as keep moving the product forward or the asset forward. and then determine after doing a market check whether we're to partner it or whether we should take it forward on our own um while we had interest it was our determination one based upon how those those potential conversations went and two based on the excitement in the space we've always been excited about the possibility of b cell inhibition for april and bath by the april and bath pathway And we made the decision to take it forward on our own and did it in a way where we're not changing at least our 24 operating expense guidance and what we've given in terms of estimates for operating free cash flow for the year. Last two questions were centered around any data. I'll T to Greg Keenan to 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 of that, to try to target a much larger area that would not be in the IGAN space. Not that we don't think the product could work in IGAN, but obviously IGAN has been the primary focus of other April bath inhibitors who are further ahead of us. On the differentiation side, let me give Greg to just talk a little bit about what we've seen to date with the compound.
spk04: 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 BAF-APRIL inhibitors, namely telatacicept and atacicept. And we find that our KDs and IC50s are lower, meaning we have more compound and equivalent milligram amount of drug. And so we think that is going to be a favorable attribute for AUR200 as we advance it. We don't have those comparisons for Ovitacicept. Relative to how this particular strategy fits compared to other B-cell inhibitors and depleters, we think that given the presumed combination of efficacious reductions in B cells and reductions in quantitative immune globulins that we expect to see against the backdrop of perhaps a maintenance of the ability to have an adaptive immune response. We think that the efficacy and safety profile will be one that compares favorably relative to other B cell depleting strategies. Hence, we think it will be a very useful agent in many B cell driven diseases.
spk03: Thanks for all the color.
spk06: Thanks, Joe. Your next question comes from Stacy Ku with TD Cowan. Your line is open.
spk00: Thanks so much for taking our questions. So we had a few. Just back to the hospital channel that we asked about last time. I know it's still early days, but just help us understand where you think that's going to progress this year and the next few years. It seems like the patient restarts and hospital channel additions are going to be quite important as we think about who kind of is moving forward. And then some metrics around these patient restarts. What's the average amount of time off treatment before the restart? Obviously, probably above 12 months, but just help us understand why they're coming back. Is it a relapse? How do you capture these patients and convert them into more chronic therapy? And then last question is going to be on the long-term trajectory. Just your thoughts around the competitive landscape. So we believe Roche's Obituzumab will have their phase three readout this summer for lupus nephritis. So just curious, any thoughts there? Thanks so much. Okay.
spk08: making sure i have all these let me start first with the hospital channel um because we haven't broken these out let me give a little bit more direction on kind of how these have have rolled through um i think right now the smaller of the two numbers in terms of restarts and the hospital channel has clearly been the hospital channel and we've talked about that um i i would It's hard to say we have enough to really trend it out yet, Stacey, but we're 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 10 patients per queue 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, twosies to now being as high as 30, 40, 50 patients a quarter. And on a base of, you know, four to five to 600 patients per quarter of new patients, you know, 10 to 20% of that base coming from the hospital channel, our hope would be that that's going to continue to grow. And everything points to that. The average in terms of restarts, they have to be, in order to be a restart in our qualification, they have to be off therapy for at least four months. I don't think I have at my hands of those restarts that we have what their average has been. But for us, 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 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 Safnello and and Roche's product, Gaziva, the two that my understanding from what they've reported, Roche hopes to have data soon, hopes to file this year, potentially be on market if data is positive by as soon as next year, and then Safnello is more protracted. Let me start with Safnello. Obviously, they ran a Phase II study. That study did not show a difference in terms of statistically significant difference in terms of reduction in proteinuria, but they did move forward with a Phase III. So, we'll see, and that's a couple years off. both by different pathways, and Greg can build on this if I miss anything, are targeting B cells. So it's our belief that much like Ben-Lista, the data will probably work, but will probably have a more protracted impact in terms of is their impact in 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 good as we do. and these have not been cross-compared, obviously, but in the study data for each individual agent appear to show that they work about as good as we do at a year at two years. These patients have a serious complication to 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?
spk04: No, I think you were spot on. I think the punchline is there's definitely a role for leukinus in many of these scenarios, and it does, with the evidence we've shown, work very, very quickly in these B cells. depleting agents just take that much longer, and that's something clinicians need to be mindful of.
spk08: Other modalities we haven't seen any new interest and or information on and seem to be well off in the time period. The two big ones coming soon are the larger companies. Hopefully, one of these larger companies will also start to focus on educating docs 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 resource and more dollars to do that.
spk00: Okay. That's really helpful. Thank you so much.
spk08: Thanks, Stacey.
spk06: Your next question comes from Ed Arce with HC Wainwright. Your line is open.
spk02: Hi, guys. Thanks for taking my questions and congrats on the quarter. A few questions for me. First, I just wanted to ask, I know this has already been discussed a little bit, but wanted to get a little bit more clarity, if I could, on the PSF and hospital restart numbers, both sequentially down. Just thinking about, you know, the regular annual seasonality first quarter obviously has the insurance restarts is typically a little light. So I'm wondering if you can discuss the seasonality, if there's any from 1Q to 2Q, and how that fits overall with you lowering the end of your guidance range for this year. And then on the income statement, Just looking at your restructuring, I know you had guided initially to 11 to 15 million. You really only have less than eight so far. Just wanted to confirm there won't be any further charges in the third quarter. And then lastly, if you could, the number of share buybacks in the quarter, the number and the amount spent. And then I have a follow up, thanks. Okay.
spk08: Well, let me, I'll let Joe handle both the P&L and or income statement questions that were asked. On the PSF hospital thing and the 1Q to 2Q in relation to how we've guided for the year, As I said previously, and I want to reiterate, I think there's a level of consistency in terms of the business trends that we've seen from 1Q to 2Q and the effect of, which we still characterize more qualitatively as patients, just less patient activity in the offices as well as less doc activity in the offices during the summertime. which I think makes a lot of sense based upon the fact that we have a relatively young patient population, has been consistent since we've launched the product. And the trends that we've seen so far this year align with what we've seen historically and are up year over year, albeit there is the recognition we'd like them to be up even more. As it relates to our guidance for the year, We've posted, I think in total, about 107 million year to date. We would have to see, in order to hit the low end range of our guidance of what was previously 200, we would have to see a significant decrease in the business in the back half of the year. We don't project that, Ed. We project, even if we have a down summer, consistency. And if we are consistent, we will fall within that guidance range and be, you know, well in that guidance range. So we feel comfortable about it based upon that assumption. If we see a great summer performance, we should be at the higher end of that guidance range, or maybe when we report 3Q, we adjust that. But we feel comfortable with the range that we've given based upon that. In terms of the charges, I think if you go back on the transcript, Joe actually addressed this, but I'll help him address it again. And then buybacks, what we did in the Q was in the transcript as well, but let us reiterate it for you.
spk07: Thanks for the question, Ed. Yeah, 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 restructure 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 regards to your second question related to the share repurchase program, I think we disclosed that March 31st that we acquired approximately 2.4 million shares. As of July 31st, we have repurchased approximately 3.4 million shares. So roughly in the time between March 31 and July 31st, approximately 1 million additional shares have been repurchased.
spk02: Great. Fantastic. Then last question, perhaps this is for Greg. Regarding AUR 200, you've decided to move forward and have stated there's a 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
spk04: um data that you expect to report thanks thanks for the question so as you know uh bath april inhibitors um they um block the um maturation and proliferation of uh um short uh live plasma cells uh specifically the ones that are thought to generate um the pathologic uh 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 immune globulin. So IgG, IgM, and IgA. We'll be looking to see what percentage relative to baseline 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. So that will be the key set of numbers that we'll be looking at as it relates to biologic activity.
spk08: The essence of what we're trying to do here is look at those who were ahead of us too and what they've reported on and try to give as much like-to-like data. So, you know, 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 in how they're hitting these targets. So, 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 aprograph space.
spk02: Very helpful. Thank you so much.
spk08: Thanks, Ed.
spk06: At this time, there are no further questions. I'd like to turn the call back over to our speakers for any further remarks.
spk08: 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 it forward. Thanks for your time, everyone.
spk06: Thank you, everyone, for attending the Orania Pharmaceuticals second quarter 2024 earnings call. Have a wonderful rest of your day.
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