Q1 2024 Aurinia Pharmaceuticals Inc Earnings Call

Operator: Greetings, and welcome to the Aurinia Pharmaceuticals first quarter 2024 earnings call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad.

Greetings and welcome to the Iridium Pharmaceuticals first quarter 'twenty 'twenty four earnings call.

At this time, all participants are in listen only mode.

Question and answer session will follow the formal presentation. If anyone should require operator assistance. Please press star zero on your telephone keypad as a reminder, this conference is being recorded.

Operator: As a reminder, this conference is being recorded. It's now my pleasure to turn the conference over to Andrea Christopher, head of Corporate Communications and Investor Relations for Aurinia Pharmaceuticals. Please go ahead, Andrea.

It's now my pleasure to turn the conference over to Andrea Christopher Head of corporate Communications and Investor Relations for any of Pharmaceuticals. Please go ahead Andrea.

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 Aurinia's 2024 first 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.

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 or any as Chief Executive Officer, Joe Miller, Our Chief Financial Officer, and Dr. Greg <unk>, our Chief Medical Officer.

Andrea Christopher: For more information, please refer to Aurinia's filings with the U.S. Securities and Exchange Commission and applicable 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.

Andrea Christopher: Today, we will review and discuss <unk> 'twenty 'twenty, four first quarter financial and operational results as communicated in the company's press release issued this morning.

Andrea Christopher: The company also filed its quarterly financial statements on Form 10-Q. This morning for more information. Please refer to erroneous filings with the U S Securities and Exchange Commission and applicable Canadian Securities authorities, which are also available on our radius website at hernia pharma Dot com during today's call Iridium may make forward looking statements based on current.

Andrea Christopher: These forward looking statements are subject to a number of significant risks and uncertainties and actual results may differ materially.

Andrea Christopher: For a discussion of factors that could affect <unk> future financial results and business. Please refer to the disclosures and erroneous 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.

Andrea Christopher: Please note that all statements made during today's call are current as of today, Thursday, May 2, 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 date. Now, let me turn the call over to Aurinia's President and CEO, Peter Greenleaf.

Andrea Christopher: Please note that all statements made during today's call are current as of today Thursday may seven 2024, unless otherwise noted and are based upon information currently available to us.

Andrea Christopher: Except as required by law hernia assumes no obligation to update any such statements now let me turn the call over to erroneous President and CEO Peter Greenleaf Peter.

Peter S. Greenleaf: Thanks, Andrew, 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 first quarter performance. I'll then turn the call over to Joe Miller, our CFO, to provide additional details on our financial results. We saw continued strong momentum in the first quarter, reflecting the initiatives that the companies focused on, including demonstrating solid commercial execution, rapidly restructuring the company and reducing our headcount by approximately 25%, and accelerating the company's timeline toward cash flow positivity.

Peter S. Greenleaf: Thanks, Andrea and good morning, everyone I want to thank everybody for joining us on today's call.

Peter S. Greenleaf: On this mornings call, we will focus on the company's first quarter performance.

Peter S. Greenleaf: I'll, then turn the call over to Joe Miller, our CFO to provide additional details on our financial results.

Peter S. Greenleaf: We saw continued strong momentum in the first quarter, reflecting the initiatives that the company is focused on including demonstrating solid commercial execution.

Joseph M. Miller: Rapidly restructuring the company and reducing our head count by approximately 25%.

Joseph M. Miller: And accelerating the companys timeline towards cash flow positivity.

Peter S. Greenleaf: So now, let me dive into the first quarter business performance and how we're executing on these overall initiatives. For the first quarter of 2024, Aurinia achieved $50.3 million in total net revenue, representing growth of approximately 46% year over year.

Joseph M. Miller: So now let me dive into the first quarter business performance and how we're executing on these overall initiatives.

Joseph M. Miller: For the first quarter of 2020 for Iranian achieved $53 million in total net revenue representing growth of approximately 46% year over year.

Peter S. Greenleaf: We achieved $48.1 million in net product revenue, representing significant growth of approximately 40%. With this momentum, we remain on track to achieve our net product revenue guidance range of approximately 200 to 220 million U.S. dollars. In terms of our restructuring efforts, we executed with speed and precision following the announcement on February 15th, while maintaining our focus on loop kinase and growth. While we've ceased development on AUR 300, we are currently exploring alternative approaches for AUR 200.

Joseph M. Miller: We achieved $48 $1 million in net product revenue representing significant growth of approximately 40%.

Joseph M. Miller: With this momentum we remain on track to achieve our net product revenue guidance range of approximately 200 to 220 million U S dollars.

Joseph M. Miller: In terms of our restructuring efforts, we executed with speed and precision following the announcement on February 15th while maintaining our focus on loop kind of some gross.

Joseph M. Miller: While we've ceased development on a EUR 300, we are currently exploring alternative approaches for AUR to hungry.

Peter S. Greenleaf: Taken as a whole, we expect the restructuring will drive the organization to a cash flow positive position, excluding share repurchases, and over time will provide a meaningful accumulation of cash, increasing tangible value, and allowing more flexibility for the company for the future. As part of our corporate restructuring, we reduced employee headcount by approximately 25% in the first quarter.

Joseph M. Miller: Taken as a whole we expect the restructuring will drive the organization to a cash flow positive position, excluding share repurchases and over time, we will provide meaningful accumulation of cash increasing tangible value and allowing more flexibility for the company for the future.

Joseph M. Miller: As part of our corporate restructuring, we reduced employee head count by approximately 25% in the first quarter with this effort, we expect to reduce operating expenses by 50 to 55 million over the next 12 months and approximately 75% of that will be recognized in this year.

Joseph M. Miller: The company expects total annualized operating expenses on a go forward basis to be in the range of 185 to 195 million with.

Joseph M. Miller: With cash based operating expenses of approximately $155 million to $165 million.

Peter S. Greenleaf: With this effort, we expect to reduce operating expenses by $50-55 million over the next 12 months, and approximately 75% of that will be recognized this year. The company expects total annualized operating expenses on a go-forward basis to be in the range of $185 to $195 million, with cash-based operating expenses of approximately $155 to $165 million. With these achievements in mind, I'm very pleased to confirm that we expect to be cash flow positive, excluding share repurchases, in the second quarter of 2024, ahead of our prior projection.

Joseph M. Miller: With these achievements in mind I'm very pleased to confirm that we expect to be cash flow positive excluding share repurchases in the second quarter of 2024 ahead of our prior projections.

Peter S. Greenleaf: On the commercial front, we are laser focused on driving loop kinase revenues and have several key commercial metrics driving the brand's trajectory. In the first quarter, we added 448 patient start forms and approximately 148 new patients who were either restarting lupkinase or receiving it through the hospital pharmacy. Together, these total approximately 596 PSFs in combination with restarts and hospital fills versus 466 PSFs in the prior year's first quarter, representing substantial year-over-year growth.

Joseph M. Miller: On the commercial front, we are laser focused on driving loop kindness revenues and have several key commercial metrics driving the brand's trajectory.

Joseph M. Miller: In the first quarter, we added 448 patient start forms and approximately 148, new patients who are either restarting loop kindness are receiving it through hot the hospital pharmacy.

Joseph M. Miller: Together. These total approximately 596 P. S apps in combination with restarts in hospital sales versus 466 P. S apps in the prior year first quarter, representing substantial year over year growth.

Peter S. Greenleaf: There were approximately 2,178 patients on lupokinase therapy as of March 31st, 2024. In comparison to approximately 1,731 patients as of March 31st, 2023, an increase of approximately 26%. And this was driven by overall improvements in all key commercial metrics.

Joseph M. Miller: There were approximately 2178 patients on <unk> therapy as of March 31, 2024, and comparison to approximately 17 131 patients as of March 31, 'twenty through 2023, an increase of approximately 26% and this was driven.

Joseph M. Miller: By overall improvements in all key commercial metrics.

Peter S. Greenleaf: Net realizable revenue per patient for Lupconnus remains higher than our initial guidance of $65,000 per patient on an annualized basis. As persistency, adherence, and pricing have evolved over time, we now believe that net realizable revenue per patient will be in the range of $70,000 to $75,000 on an annualized basis. From the start of the year through April 28, 2024, the company has added approximately 582 PSFs and approximately 170 new patients from restarts in the hospital channel.

Joseph M. Miller: Net realizable revenue per patient for loop kindness remains higher than our initial guidance of 65000 per patient on an annualized basis.

Joseph M. Miller: As persistency adherence and pricing has evolved over time, we now believe that net realizable revenue per patient will be in the range of 70 to $75000 on an annualized basis.

Joseph M. Miller: From the start of the year through April 28, 2024. The company has added approximately 582 P. S Fs and approximately 170, new patients from restarts in the hospital channel.

Peter S. Greenleaf: We continue to sustain high conversion rates, 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 rates remained high at 87% through the first quarter, and persistency grew year over year from approximately 51% of patients remaining on therapy at 12 months to approximately 56% remaining on therapy at 12 months. Additionally, in the first quarter, 50% and 46% of patients remained on therapy at 15 and 18 months, respectively. Based on all of the above, we are reiterating our full-year guidance.

Joseph M. Miller: We continue to sustain high conversion rates with approximately 85% of psf's converting to patients on therapy.

Joseph M. Miller: We also sustained a rapid conversion time with approximately 60% of patients starting therapy within 20 days.

Joseph M. Miller: Our overall adherence rates remained high at 88, 7% through the first quarter and persistency grew year over year from approximately 51% of patients remaining on therapy at 12 months to approximately 56% remaining on therapy at 12 months.

Joseph M. Miller: Additionally, in the first quarter, 50% and 46% of patients remained on therapy at 15, and 18 months respectively.

Joseph M. Miller: Based on all of the above we are reiterating our full year guidance.

Peter S. Greenleaf: Our metrics demonstrate continued growth that is driving the upward trajectory of Leukinas. We are heading towards cash flow positivity and increasing the company's financial strength and flexibility for the future. Along with this strong financial performance, we also recently achieved several key milestones reflecting the importance of lupokinase as a best-in-class drug with a strong clinical portfolio that aligns with the most current treatment guidelines. For example, as announced earlier this week, the FDA has approved a label update for lupikinib. The label no longer includes language indicating that the safety and efficacy of leukinas have not been established beyond one year. Instead, the label now includes long-term data from a post-hoc analysis of the Aurora II extension study.

Joseph M. Miller: Our metrics demonstrate continued growth that is driving the upward trajectory of loop kindness.

Joseph M. Miller: We are heading towards cash flow positivity in increasing the company's financial strength and flexibility for the future.

Joseph M. Miller: Along with this strong financial performance. We also recently achieved several key milestones, reflecting the importance of loop kindness as a best in class drug with its strong clinical portfolio that aligns with the most current treatment guidelines.

Joseph M. Miller: As announced earlier this week the FDA has approved a label update for loop kindness.

Joseph M. Miller: The label no longer includes language, indicating that the safety and efficacy of loop kindness has not been established beyond one year.

Joseph M. Miller: The label now includes long term data from a post hoc analysis of the Aurora two extension study.

Peter S. Greenleaf: The data showed that patients receiving lupokinase achieved sustained complete renal responses at every time point assessed throughout the three years when compared to MMF and low-dose glucocorticoids alone. Moving to our marketing efforts, we recently launched the Know the Signs campaign, an innovative and new campaign designed to increase awareness among rheumatologists about the severity of lupus nephritis and the urgent need to prioritize kidney health for people with lupus, as well as encourage them to increase screening for lupus nephritis among lupus patients. With an underdiagnosed and underserved population, we continue to believe there is still significant untapped potential in the LN market. Current screening and treatment guidelines are not actually being followed.

Joseph M. Miller: The data showed that patients receiving loop kindness achieve sustained complete renal response at every time point assessed throughout the three years, when compared to MMF and low dose globe glucocorticoid steroids alone.

Joseph M. Miller: Shifting to our marketing efforts, we recently launched the no the signs campaign and innovated a new campaign designed to increase awareness among rheumatologists about the severity of lupus nephritis and the urgent need to prioritize kidney health for people with lupus as well as encouraging.

Joseph M. Miller: [noise] them to increase screening for lupus nephritis, among lupus patients.

Joseph M. Miller: With an underdiagnosed and underserved population, we continue to believe there is still significant untapped potential in the airline market.

Joseph M. Miller: Current screening and treatment guidelines are not actually being followed we know that high a high percentage of lupus and lupus nephritis patients are not being given regular urine screens at every visit and may still only receive steroids when proteinuria levels indicate additional treatment is necessary yet.

Peter S. Greenleaf: We know that a high percentage of lupus and lupus nephritis patients are not being given regular urine screens at every visit and may still only receive steroids when proteinuria levels indicate additional treatment is necessary. Yet, our clinical trials have shown that lupokinase reduced proteinuria roughly three times faster than MMF alone. This is why we're heavily focused on improving physicians' understanding of the seriousness of lupus nephritis. We want rheumatologists to understand the necessity of more aggressively treating and diagnosing LN patients by treating them to target protein levels and keeping them on therapy for a minimum of three to five years, all of which closely aligns with current treatment guidelines.

Joseph M. Miller: Yet our clinical trials have shown that <unk> reduce proteinuria, roughly three times faster than MMF and steroids alone.

Joseph M. Miller: This is why we're heavily focused on improving physicians understanding of the seriousness of lupus nephritis.

Joseph M. Miller: We want rheumatologist to understand the necessity of more aggressively treating in diagnosing L N patients by treating to target protein levels and keeping them on therapy for a minimum of three to five years, all of which closely aligns with current treatment guidelines.

Peter S. Greenleaf: Regarding commercial activities outside the U.S., we're seeing continued revenue from Otsuka's launch activities in Europe, and we're also working diligently to expand access to lupkinis to another key market with our pending regulatory approval in Japan. As previously noted, we expect to receive a response from the Japanese regulatory authorities in the second half of this year regarding the JNDA that Otsuka filed in November of 2023 for the approval of lupkinase to treat adults with active lupus nephritis.

Joseph M. Miller: Regarding commercial activities outside the U S.

Joseph M. Miller: We're seeing continued revenue from otsuka as launch activities in Europe, and we're also working diligently to expand access to look kind of to another key market with our pending regulatory approval in Japan.

Joseph M. Miller: As previously noted we expect to receive a response from the Japanese regulatory authorities in the second half of this year regarding the J NDA that Asuka filed in November of 2023 for the approval of loop kind of <unk> to treat adults with active lupus nephritis.

Peter S. Greenleaf: Upon approval, we expect to receive a milestone of $10 million, and from there, low double-digit royalties on net sales once launched. In summary, we believe our first quarter accomplishments reflect solid execution against our previously announced business priorities. I also want to recognize that May is Lupus Awareness Month. At Aurinia, we take great pride in the work we do every day to improve the lives of people living with lupus nephritis. We are committed to making a difference for this patient community, and we never lose sight of that.

Joseph M. Miller: Upon approval, we expect to receive a milestone of $10 million and from their low double digit royalties on net sales once launched.

Joseph M. Miller: So in summary, we believe our first quarter accomplishments reflect solid execution against our previously announced business priorities.

Joseph M. Miller: I also want to recognize it may as lupus awareness month at <unk>, we take great pride in the work we do every day to improve the lives of people living with lupus nephritis, we are committed to making a difference for this patient community and we never lose sight of that.

Peter S. Greenleaf: I'd now like to turn the call over to Joe for a more detailed review of the financial results. But I'll return at the end of the call for a quick recap, and then open the line to any questions that you might have.

Joseph M. Miller: I'd now like to turn the call over to Joe for a more detailed review of the financial results.

Joseph M. Miller: But I'll return at the end of the call for a quick recap and then open the line to any questions that you might have Joe.

Joseph M. Miller: Thank you, Peter, and good morning, everyone. Let's take a few minutes and go into detail regarding our financial results for the first quarter of 2024. Total net revenue was $50.3 million and $34.4 million for the three months ended March 31, 2024 and March 31, 2023, respectively. Net product revenue over the same periods was $48.1 million and $34.3 million, representing growth of approximately 46% and 40%, respectively. The increase is primarily due to an increase in luteinic cells from our two main specialty pharmacies, driven predominantly by further penetration of the LN mark.

Joseph M. Miller: Thank you Peter and good morning, everyone, let's take a few minutes and go into detail regarding our financial results for the first quarter of 2024 <unk>.

Joseph M. Miller: Total net revenue was $50 3 million and $34 4 million for the three months ended March 31, 2024 at March 31 2023, respectively.

Joseph M. Miller: Net product revenue over the same periods was $48 1 million and $34 3 million representing growth of approximately 46% and 40% respectively. The.

Joseph M. Miller: The increase is primarily due to an increase in loop kind of sales from our two main specialty pharmacies driven predominantly by further penetration of the Ellen market.

Joseph M. Miller: Total cost of sales and operating expenses, inclusive of a one-time restructuring charge in Q1 2024, were $63.6 million for the quarter ended March 31, 2024, and $64 million for the quarter ended March 31, 2023. It is important to note that the first quarter was fairly burdened from an operating expense standpoint, as the restructuring charge was not fully implemented until late in the first quarter of 2024. Let me now give you a further breakdown of operating expenses, drivers, and fluctuations.

Joseph M. Miller: Total cost of sales and operating expenses inclusive of one time restructuring charge in Q1 2024 were $63 6 million for the quarter ended March 31, 2024, and $64 million for the quarter ended March 31 2023.

Speaker Change: It is important to note that the first quarter was fairly burden from an operating expense standpoint, as the restructuring charge was not fully implemented until late in the first quarter of 2024.

Speaker Change: Let me now give you a further breakdown of operating expenses drivers and fluctuations.

Joseph M. Miller: Cost of sales was $7.8 million for the quarter ended March 31, 2024 and $421,000 for the quarter ended March 31, 2023. The increase is primarily due to increased sales of LoopKindness coupled with the amortization of the monoplant finance right of use asset, which was placed into service in late June 2023.

Speaker Change: Cost of sales was $7 8 million for the quarter ended March 31, 2024, and 421000 for the quarter ended March 31, 2023. The increase is primarily due to increased sales of boot kindness, coupled with the amortization of the monoplane finance right of use asset which was placed into service in late June 2023.

Joseph M. Miller: Gross margins for the quarter ended March 31, 2024 and March 31, 2023 were approximately 85% and 99%. Selling, general, and administrative expenses, inclusive of share-based compensation, were $47.7 million and $50.1 million for the three months ended March 31, 2024 and March 31, 2023, respectively. The primary drivers for the decrease were lower corporate costs, employee-related costs due to the reduction in headcount, which occurred late in the first quarter of 2024, and lower spend on travel.

Speaker Change: Gross margins for the quarter ended March 31, 2024, and March 31, 2023 was approximately 85% and 99%.

Speaker Change: Selling general and administrative expenses inclusive of share based compensation were $47 7 million and $50 1 million for the three months ended March 31, 2024 at March 31 2023, respectively.

Speaker Change: Primary drivers for the decrease were lower corporate costs employee related costs due to the reduction in head count which occurred late in the first quarter of 2024 and lower spend for travel the decrease in SG&A operating expenses reflects the early impact of our restructuring efforts, though this balance does not include the one time restructuring charge the one time restructuring charge.

Joseph M. Miller: The decrease in SG&A operating expenses reflects the early impact of our restructuring efforts, though this balance does not include the one-time restructuring charges. The one-time restructuring charges are reflected as a stand-alone line item in the Profit and Loss Statement and will be discussed separately in a moment.

Speaker Change: Is reflected as a standalone line item in the profit and loss statement and will be discussed separately in a moment.

Joseph M. Miller: Non-cash SG&A share-based compensation expense was $7.5 million for the first quarter of 2024 and $7.6 million for the prior year period. Research and development expenses, inclusive of share-based compensation expense, were $5.6 million for the quarter ended March 31, 2024, and $13.2 million for the quarter ended March 31, 2023. The decrease is primarily related to exiting our pipeline programs, as previously announced, but does not include the impact of the one-time restructuring charge.

Speaker Change: Noncash SG&A share based compensation expense was $7 5 million for the first quarter of 2024, and $7 6 million for the prior year period.

Speaker Change: Research and development expenses inclusive of share based compensation expense was $5 6 million for the quarter ended March 31, 2024, and $13 2 million for the quarter ended March 31 2023.

Speaker Change: The decrease is primarily related to exiting our pipeline programs as previously announced but does not include the impacts of the one time restructuring charge as previously mentioned the one time restructuring charges reflected as a standalone line item.

Joseph M. Miller: As previously mentioned, the one-time restructuring charge is reflected as a standalone line item. Non-cash, share-based compensation expense included within R&D expense was a credit of $2.2 million and an expense of $1.6 million for the quarters ended March 31, 2024, and March 31, 2023. The primary driver for the decrease in share-based compensation is related to the reduction in headcount which occurred late in the first quarter of 2024. Restructuring expenses for the quarter amounted to $6.7 million, and in the prior year period to $0. The balance was primarily made up of employee severance and one-time benefit payments and contract termination costs. The company recognized most of its planned restructuring costs in the first quarter.

Speaker Change: Noncash share based compensation expense included within R&D expense was a credit of $2 2 million and an expense of $1 6 million for the quarters ended March 31, 2024 at March 31, 2023, the primary driver for the decrease in share based compensation is related to the reduction in head count which occurred late in the first quarter of 2024.

Speaker Change: Restructuring expenses for the quarter amounted to $6 7 million in the prior year period to zero. The balance is primarily made up of employee severance and onetime benefit payments and contract termination costs.

Speaker Change: The company says has recognized most of its planned restructuring costs in the first quarter.

Joseph M. Miller: Other income was $4.1 million, and interest expense was $1.3 million for the quarter ending March 31, 2024, compared to other income of $290,000 and no interest expense for the prior year period. The changes for both other income and interest expense related to our monoplant finance right of use asset, which is denominated in Swiss francs and was placed into service in late June 2023. Interest income was $4.5 million for the quarter ended March 31, 2024, and $3.8 million for the prior year period. The increase is due to higher yields in our investments as a result of increased interest.

Speaker Change: Other income was $4 1 million and interest expense was $1 3 million for the quarter ended March 31, 2024 compared to other expense of 290000 and no interest expense for the prior year period.

Speaker Change: The changes for both other income and interest expense related to our motto plant finance right of use asset which is denominated in Swiss francs and was placed into service in late June 2023.

Speaker Change: Interest income was $4 5 million for the quarter ended March 31, 2024, and $3 8 million for the prior year period. The increase is due to higher yields in our investments as a result of increased interest rates.

Joseph M. Miller: Aurinia recorded a net loss of $10.7 million, or $0.07 net loss per common share, for the quarter ended March 31, 2024, as compared to a net loss of $26.2 million, or $0.18 net loss per common share, for the quarter ended March 31, 2023. As of March 31, 2024, Aurinia had cash, cash equivalents, and restricted cash investments of $320.1 million, compared to $350.7 million at The decrease is primarily related to continued investment in commercialization activities and post-approval commitments for our approved drug Lupkinas, monoplant payments, share repurchases, and restructuring-related payments partially offset by an increase in cash receipts from sales of Lupkinas. The company remains debt-free at March 31, 2020. With that, I would like to hand the call back over to Peter for some closing remarks. Okay, Peter?

Speaker Change: <unk> recorded a net loss of $10 7 million or <unk> <unk> net loss per common share for the quarter ended March 31, 2024, as compared to a net loss of $26 2 million or 18 net loss per common share for the quarter ended March 31 2023.

Joseph M. Miller: As of March 31, 2024, hernia had cash cash equivalents and restricted cash and investments of $320 1 million compared to $350 7 million at December 31, 2023. The decrease is primarily related to continued investment in commercialization activities and post approval commitments of our approved drugs loop kindness.

Speaker Change: Mono plant payments share repurchases and restructuring related payments, partially offset by an increase in cash received from sales of the kindness.

Speaker Change: Company remains debt free at March 31, 2024.

Speaker Change: With that I would like to hand, the call back over to Peter for some closing remarks Peter.

Peter S. Greenleaf: Thanks, Joe. Obviously, we're looking forward to continued strong performance in 2024 and beyond. I want to thank you all for your time today. We will now open up the lines for any questions you might have. Operator?

Peter: Thanks, Joe obviously, we're looking forward to continued strong performance in 2024 and beyond I want to thank you all for your time today, we will now open up the lines for any questions you might have operator.

Operator: Thank you. We will now be conducting your question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. We ask that you please ask one question and one follow-up. Once again, that's star 1 to be placed in the question queue. If you'd like to remove your question from the queue, please press star 2. Our first question today is coming from Maurice Raycroft from Jeffries. Your line is now live.

Speaker Change: Thank you, we'll now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad. We ask you. Please ask one question and one follow up once again, that's far wanted to be placed in the question queue, if you'd like to remove your question from the queue. Please press star two and our first question.

Maurice Thomas Raycroft: It's coming from Maury Raycroft from Jefferies. Your line is now live.

Farzin Haque: Hi, good morning. Thank you for taking my questions. This is Farzin Haque from MORI. I wanted to ask about the implications of the updated label. Your conversion rate for the PSFs has been in the mid-80s. Do you expect that to improve further, or do you expect primarily it to influence prescribers' perception of it?

Maurice Thomas Raycroft: Hi, Good morning. Thank you for taking my questions. Just first thing on for Murray I wanted to ask on the implications of the updated label your conversion rate for the PSA testing to meet <unk> do you expect that the two five inch primarily to influence the prescribers that perception of the truck.

Peter S. Greenleaf: So, thank you for the question. Listen, I think the label update is a recognition by the agency of the data that we provided in addition to the original Aurora Pivotal Study. I think it's going to be helpful not to conclude in the indication language that anything beyond one year has not been studied. To have that taken out and to have the three-year data incorporated into labels is going to help us on multiple fronts.

Speaker Change: So thank you for the question.

Peter S. Greenleaf: Listen I think the label update is a recognition of a by the agency of the data that we provided in addition to the original Aurora pivotal study I think it's going to be helpful to to not be conclude concluded in the indication language that.

Peter S. Greenleaf: Beyond one year has not been studied yet to have that taken out and to have the three year data incorporated into the label is going to help us I think on multiple fronts.

Peter S. Greenleaf: Probably not on the conversion side of the equation, but we'll see. We're looking at it more on the, probably the persistency side and ensuring that the drug gets utilized as both the ULAR and the CADEGO guidelines outline, you know, three to five years of therapy, approximately. So we see it more as persistency and length of therapy and additive to the already published data that's out there.

Peter S. Greenleaf: Probably not on the conversion side of the equation, but we will see we're looking at it more on the probably the persistence side and ensuring that the drug gets utilized is as both of you are in that could ego guidelines outlined you know three to five years of therapy, approximately so we see it more as persistency and length of therapy and ads.

Peter S. Greenleaf: To the the already published data that's out there.

Farzin Haque: Okay, makes sense. And then last month we had like 156 that I counted. The total PSS can restart.

Peter S. Greenleaf: Okay makes sense and then last month he had like 156 that account at the total PSS and restart this is trending a bit lower than the average one monthly numbers, you sat down and I'm fitness or were there any factors.

Peter S. Greenleaf: So this is trending a bit lower than the average 1Q monthly numbers. Is that general lumpiness, or were there any factors driving the Slowness in April? Well, the exact number, I think...

Farzin Haque: Driving the slowness in April.

Peter S. Greenleaf: Well, the exact number, I think, in combination, PSFs plus the restarts and hospitals, was closer to 170, so probably just, you know, you were quick doing the math. I think it was 170. If you look at that on a per week basis versus where we were in the first 13 weeks of the year, it's pretty consistent, maybe slightly lower, but pretty consistent with what we did in the first quarter of the year.

Peter S. Greenleaf: While the exact number I think in combination psf's plus the restarts and hospitals was closer to $1 70. So probably just you know you were quick doing the math I think it was what was 170. If you look at that on a per week basis versus where we were in the first.

Peter S. Greenleaf: <unk> 13 weeks of the year, it's pretty consistent maybe slightly lower but pretty consistent with what we did in the first quarter of the year. If you look at it April 23.

Peter S. Greenleaf: If you look at it on April 23, it's almost directly on target with where we were in April of 23, but that was just a PSF number last year. So if you look at PSFs sort of on, you know, April 23 versus PSFs alone in April 24, the numbers were very consistent. The big driver of the change in about a 25% improvement year over year in the month of April was driven by both restarts and hospital patients.

Peter S. Greenleaf: Almost directly on target with where we were in April at 23, but that was just a psf number flashier.

Peter S. Greenleaf: If you look at Psf sort of an eight.

Peter S. Greenleaf: April 23 versus Psf's alone and April 24, the numbers were very consistent the big driver of the change in in about 25% improvement year over year in the month of April was driven by.

Peter S. Greenleaf: Both restarts in hospital patients.

Speaker Change: Got it okay. Thank you so much.

Speaker Change: Thank you Sir.

Stacy Ku: Thank you. The next question today is coming from Stacy Ku from TD Cowen. Your line is now live.

Peter S. Greenleaf: Thank you next question today is coming from Stacy <unk> from TD Cowen. Your line is now live.

Stacy Ku: Okay.

Stacy Ku: Hey there, and sorry if I repeat a question because I got kicked off momentarily. So thanks so much for taking our questions. We did have a few.

Stacy Ku: Hey, there and sorry, if I repeat a question because I got kicked off momentarily. So thanks, so much for taking our questions. We did have a few first as a follow up to what I believe was the first question. Just can you talk about big picture, what's your evolving thoughts around patient start forms and the current cancer physicians as he.

Peter S. Greenleaf: First, is a follow-up to what I believe was the first question. Just can you talk about the big picture, what your evolving thoughts are around patient start forms and the current cadence of additions as we look forward, and then how important are formulary purchases in the hospital channel for your long-term growth? I have a few follow-ups.

Peter S. Greenleaf: Look forward and then how important is formulated purchases in the hospital channel for your long term growth. That's the first question that I have a few follow ups.

Peter S. Greenleaf: Thank you. I think it's a great question. Obviously, PSFs we see as important, but I think, as you've seen, because I think it's the best indicator of new patient volume and, you know, since 85% of those convert, new patient starts and kind of our equivalent of an NRX, right? But this emergence over the last, let's call it six to twelve months of the importance of restarting, and all be it smaller, but emerging hospital businesses show new lines of growth.

Speaker Change: Thank you I think it's a great question, obviously psf's, we see as important.

Peter S. Greenleaf: But I think as you've seen.

Peter S. Greenleaf: Because I think it's the best indicator.

Peter S. Greenleaf: New patient.

Peter S. Greenleaf: Volume and you know since 85 presented those convert new patient starts.

Peter S. Greenleaf: And kind of our equivalent of an N Rx right, but this emergence over the last let's call. It six to 12 months.

Peter S. Greenleaf: Importance of restarts.

Peter S. Greenleaf: So, albeit smaller but emerging hospital business show new lines of growth. So I the way we talk about it Stacy internally is more you know what.

Peter S. Greenleaf: So, the way we talk about it internally is more, you know, how does our new patient on therapy numbers look within the quarter? And I think that, you know, that's an important one. And that's a combination of all three.

Peter S. Greenleaf: How does our new patient on therapy numbers look within the quarter and I think that's an important.

Peter S. Greenleaf: More than one and that's that's a combination of all the three I'm not trying in any way to discount the importance of PSS, we think all our marketing and selling initiatives that we have out there. The primary driver is identifying new patients and getting new patients on drug but for the last let's call. It six six bonds plus or.

Stacy Ku: I'm not trying in any way to discount the importance of PSFs. You know, we think all our marketing and selling initiatives that we have out there are the primary driver is identifying new patients and getting new patients on the drug. But, you know, for the last, let's call it, you know, six months plus, a lot of our growth has come from both these restarts, which I think points to the importance of the Aurora 2 extension study, this label change, and the work we've been doing over the last 12 months.

Stacy Ku: Lot of our growth has come from both these restarts, which I think points to the importance of the Aurora two extension study.

Stacy Ku: This label change and the work we've been doing over the last 12 months.

Stacy Ku: But it doesn't, in my mind, discount the need to focus on new patient growth. And while the hospital patients are indeed new patients, you know, the PSFs are still a major indicator of that.

Stacy Ku: But it doesn't in any way in my mind discount the need to focus on new patient growth and while the hospital patients are indeed, new patients.

Stacy Ku: The PSS are still a major indicator for that.

Stacy Ku: Yes.

Peter S. Greenleaf: Okay, understood. And then, around your revenue guidance of $24 billion, you want to just walk through, remind us about the seasonality, quarterly cadence, expectations, and how you feel about your revenue guidance for the high and low ends this year.

Stacy Ku: Okay understood and then.

Peter S. Greenleaf: And your 24 revenue guidance, you want to just walk through or remind us not the seasonality clearly cant expectations and how you feel about kind of your revenue guidance for the high and low end this year.

Stacy Ku: Well, as you know, we don't give any, you know, numeric or sort of pillars to the high and the low, but, you know, sort of qualitatively speaking, I think the low end of the guidance with the quarter we just produced would have to see, you know, a significant decline or, you know, some challenge in the summertime, and then back to growth in the fourth quarter. And the high end of the range, this is very generally how we think of it, and getting above that range is going to be driven by how well we perform in the summer, since for three seasons now, we've had a little bit of a dip during the summertime or a flattening in the summertime.

Peter S. Greenleaf: Oh.

Speaker Change: Well as you know we don't give any.

Stacy Ku: Numeric or sort of pillars to the high and the low, but but sort of qualitatively speaking.

Stacy Ku: I think the low end of the guidance with the with the quarter. We just produced you know we'd have to see.

Stacy Ku: A significant decline or or some challenge in the summertime and then back to growth in the fourth quarter and the high end of the range and this is very generally how we think of it and getting above that range is going to be driven by how well we perform in the summer since for three seasons now we've had a little bit of a dip.

Stacy Ku: During the during the summer time or a flattening in the summer time, if we can power through that we think we have the ability to be in the upper upper end of that range. Lastly, I think <unk> performance will be a key driver to look at guidance in general and see where we are for the year and are you now with that.

Stacy Ku: If we can power through that, we think we have the ability to be in the upper end of that range. Lastly, I think, you know, 2Q performance will be a key driver to look at guidance in general and see where we are for the year. And, you know, if that outperforms, then we'll come back to the table and talk about where we see the year coming out. But the biggest swing on 200 to that 220 range is going to be, you know, during the summer months of the year.

Stacy Ku: <unk> then, we'll we'll come back to the table and talk about where we see the year coming out but the biggest swing on 200 did that to 220 range is gonna be the summer months of the year.

Peter S. Greenleaf: Okay, understood. And then last question is just a follow-up on your comments around exploring alternative approaches for your pipeline product 200, but just help us understand what that means. Can you go into a little bit more detail for us? Thank you so much.

Speaker Change: Okay understood and then last question is just a follow up on your comments around exploring alternative approaches for and your pipeline product 200, but just help us help us understand what does that mean can you go into a little bit might be tail for us. Thank you so much.

Peter S. Greenleaf: Yeah, I think the short answer is that the difference between AUR200 and AUR300 in our pipeline is that we own AUR200. Yes, we have follow-on commitments to those that we purchased it from, very minimal, but we do have commitments.

Speaker Change: Yeah, I think the short answer is the difference between EUR 203 hundred in our pipeline was we own EUR 200, yes, we have follow on commitments to those that we purchased it from very minimal, but we have we do have commitments.

Peter S. Greenleaf: So we will either seek to develop the drug through someone else or to efficiently move the drug forward on our own if, in fact, conversations with others don't produce the type of, you know, value that we would see for the asset and the type of speed we would want for the asset. So in other words, we don't want to just, you know, shelve it and not get the value of, you know, this APRILBAF inhibitor, which obviously more and more data emerge every day in the APRILBAF space as it pertains to IgAN in particular, but we think more broadly there's going to be a place for APRILBAF inhibitors in the B-cell pathway in much more immunology disorders moving forward. So we want to keep this thing moving forward, whether it's in our own hands or someone else's.

Peter S. Greenleaf: So we will either seek to develop the drug through someone else or to efficiently move the drug forward on our own. If in fact, you know conversations with with others don't produce the type of value that we would see for the asset and the type of speed, we would want for the asset. So in other words, we don't.

Peter S. Greenleaf: Want to just shelve, it and not get the value of this April Bath inhibitor, which obviously more and more data emerges every day on April <unk> space as it pertains to IGN in particular, but we take more broadly there's going to be a place for <unk> for April Bath <unk> inhibitors in the B cell.

Peter S. Greenleaf: Pathway.

Peter S. Greenleaf: And much more immunology disorders moving forward. So we want to keep this thing moving forward, whether it's in our own hands or someone else's.

Stacy Ku: Okay, I understand. Thank you so much.

Speaker Change: Okay understood.

Speaker Change: Thank you so much.

Speaker Change: Thanks Stacy.

Joseph Patrick Schwartz: Thank you. As a reminder, that's star number one to be placed in the question queue. Our next question is coming from Joseph Schwartz from Leering Partners. Your line is now live.

Stacy Ku: Thank you as a reminder, that far one to be placed in the question queue. Our next question is coming from Joseph Schwartz from Leerink Partners. Your line is now live.

Joseph Patrick Schwartz: All right, thank you, and...

Joseph Patrick Schwartz: Alright, Thank you and congrats.

Joseph Patrick Schwartz: Congrats on a strong quarter I wanted to ask first about your initiatives around screening and diagnosis, whereas the community now on that front, how much screening is being done and how much have you been able to move that needle.

Joseph Patrick Schwartz: And how is progress there.

Joseph Patrick Schwartz: Going to new patient starts relative to the other initiatives you have ongoing.

Peter S. Greenleaf: Thanks for the question, Joe. I think we have one series of, you know, sort of physician-reported AAU that's been done. And at least at the rheumatologist level, what we can tell you is that we're seeing some improvement in treatment. We're seeing some improvement in awareness of the need to diagnose lupus patients and do urine screens. We haven't seen that, Joe, pull through yet to actual claims data. And, you know, there's no direct, it's not one-to-one, and it's kind of, even our interpretation of claims data is kind of, you know, you have to take some liberties around what's submitted through the claim to try to get under that.

Joseph Patrick Schwartz: Thanks for the question Joe.

Joseph Patrick Schwartz: I think we have one series of.

Peter S. Greenleaf: It's sort of physician reported.

Peter S. Greenleaf: A you that's been done.

Peter S. Greenleaf: And at least at the Rheumatologist level, what we can tell you is that we're seeing some improvement in treatment. We're seeing some improvement in awareness of need to diagnose lupus patients and do urine screens, we haven't seen that Joe pulled through yet to actual claims data and.

Peter S. Greenleaf: There is no direct I'm not one to one and it's kind of even our interpretation of claims data is kind of you know you have to take some liberties around what submitted through the claim to try and to try to get under that what I can tell you is these numbers have been like grossly low historically at least as reported by a large.

Peter S. Greenleaf: What I can tell you is these numbers have been, like, grossly low historically, at least as reported by a large patient record audit that was done by Optum a few years ago, looking at lupus patients, a couple hundred thousand lupus patients over several years. And you're looking at numbers like, you know, less than 50% of these patients even get a urine screen. This is for lupus patients. Guidelines say they should get it every time they come in the office. And when they do have a positive proteinuria or a proteinuria level that the guidelines would indicate is indeed a lupus nephritis diagnosis, only 30% of them even get treated. And you say, well, geez, why?

Peter S. Greenleaf: Patient record audit that was done bye bye.

Peter S. Greenleaf: Optum a few years back looking at lupus patients a couple a couple of hundred thousand lupus patients over several years and Youre looking at numbers like you know less than 50% of these patients even get a urine screen. This is lupus patients guidelines say they should get it every time they come in the office and when they do have a positive proteinuria.

Peter S. Greenleaf: Or proteinuria level that that the guidelines would indicate.

Peter S. Greenleaf: Indeed, our lupus.

Peter S. Greenleaf: Lucas nephritis diagnosis, only 30% of them, even get treated and you can say well geez why.

Peter S. Greenleaf: I think one is just general awareness, and two, I think you know, hematologists.

Peter S. Greenleaf: One is just general awareness and.

Peter S. Greenleaf: I think you know.

Peter S. Greenleaf: Colleges will treat proteinuria.

Peter S. Greenleaf: Proteinuria and lupus nephritis differently I think they see lupus nephritis as several grams of proteinuria and or protein in the urine and they see low proteinuria is not indeed being nephritis now, it's a little bit of a liberty from some of the.

Peter S. Greenleaf: Research work, we've done but.

Peter S. Greenleaf: Awareness, we need to build is that even low levels are indicative of poor outcomes for the patient moving forward and you're never going to find it unless you're doing a yarn screens and I think we're making impact there more to come as we continue.

Peter S. Greenleaf: The campaign forward.

Joseph Patrick Schwartz: Yeah, it seems like a great area for your white space. I was wondering also about the updated label. I think that happened a fair amount ahead of expectations, given we were expecting an update in the second half. So can you talk about why that turned around so fast? How does the updated label fit within your expectations? And is there any potential to limit the REMS in the future with any... Additional label updates going forward?

Speaker Change: Yes, it seems like a great area for your white space.

Joseph Patrick Schwartz: I was wondering also regarding the table I think that happened.

Joseph Patrick Schwartz: Fair amount ahead of expectations.

Joseph Patrick Schwartz: Given we were expecting an update in the second half so.

Joseph Patrick Schwartz: Can you talk about why that.

Joseph Patrick Schwartz: Turned around so fast how does the updated label fit within your expectations and is there any potential to.

Joseph Patrick Schwartz: Limit the rems in the future with any.

Joseph Patrick Schwartz: Additional label updates going forward.

Peter S. Greenleaf: Um, well, we don't have a REMS in the technical sense. So maybe I'll answer the question.

Speaker Change: Well, we don't have a rems in the technical sense. So maybe I'll answer the question, maybe as Youre thinking about it Joe come back to me with what you mean by buy by the Rems.

Peter S. Greenleaf:

Peter S. Greenleaf: And maybe as you're thinking about it, Joe, come back to me with what you mean by by the REMS arm. As we previously communicated, we let the agency know that we were going to do the extension study and that we were also going to do a biopsy sub-study as part of the pivotal study. The agency said, great, we'd love to see that data, but it wasn't packaged as your classic supplemental NDA, right?

Speaker Change: As we previously community communicated.

Peter S. Greenleaf: Let the agency know that we were going to do the <unk> extension study and that we were also going to do a biopsy sub study as part of the pivotal.

Peter S. Greenleaf: The agency said, great would love to see that data, but it wasn't packaged as your classic supplemental.

Peter S. Greenleaf: So when we fed this data to the U.S. FDA, obviously, we were glad they would take it, but understood that it could potentially fall outside of, you know, the technical supplemental new drug application process. The agency luckily treated it much like a supplemental, and, you know, they performed within the 9 to 12 months category of what a normal supplemental is. And, you know, we were more conservative in our estimate because this technically wasn't, in our view, a supplemental NDA package. So it came earlier than maybe we got it externally, which is a positive. And, you know, I think in terms of our expectations, it was pretty much everything we had expected.

Joe: NDA right so when we.

Peter S. Greenleaf: Fed this data to the U S. FDA, obviously, we were glad they would take it but understood that it wasn't it could potentially fall outside of the tech to class.

Peter S. Greenleaf: Technip technical.

Peter S. Greenleaf: The supplemental new drug application process.

Peter S. Greenleaf: Agency Luckily treated it much like a supplemental and.

Peter S. Greenleaf: <unk> performed within the nine to 12 months category of what a normal supplemental is and.

Peter S. Greenleaf: We were more conservative probably in our estimate because just technically wasn't in our view a supplemental NDA package. So it came earlier than than maybe the way, we guided externally, which is a positive and you know I think.

Peter S. Greenleaf: In terms of our expectations. This hit pretty much on everything we had expected we wanted the language removed from the indication statement now that there's more than one year data and we wanted the data incorporated I will say that the.

Peter S. Greenleaf: We wanted the language removed from the indication statement now that there is more than one year of data, and we wanted the data incorporated. I will say that the biopsy sub-study data was not incorporated, but we don't think that's limiting. We think that data can still be made available through publication and through a medical drug and information request form.

Peter S. Greenleaf: A biopsy sub study data was not incorporated but we don't think that's limiting we think that that data can still be made available through publication and through medical drug information request forms.

Joseph Patrick Schwartz: That makes sense. That answers my question.

Speaker Change: That makes sense that answers my question and then what about you.

Speaker Change: Your your recently announced buyback have you made any progress.

Peter S. Greenleaf: And then what about your recently announced buyback? Have you made any progress? Have you bought any shares back yet? Short answers, yes.

Joseph Patrick Schwartz: Hum.

Joseph Patrick Schwartz: The shares back yet.

Peter S. Greenleaf: Short answers, yes. Within the quarter, we actually up until the, I believe this is up until the end of April, we purchased about $18.4 million worth of stock at an average cost of $5.37, which equates to about 3.4 million total shares. Just for the future, because I'm sure that's kind of the follow-on question, you know, we would look to fund any future purchases through discretionary repurchases through cash flows and not through what's cash on hand, and it's at the board's discretion. So, you know, we'll report out more as we go here, but $18.4 through the end of April.

Antonio Eduardo Arce: Thank you. The next question is coming from Ed Arce from H.C. Wainwright. Your line is now live.

Peter S. Greenleaf: Short answer's, yes.

Antonio Eduardo Arce: Within the quarter bump, we actually up until the I believe this is up until the.

Antonio Eduardo Arce: The end of April we.

Antonio Eduardo Arce: We purchased about $18.4 million worth of stock with an average cost of $5.37, which equates to about $3 4 million.

Antonio Eduardo Arce: Total shares.

Antonio Eduardo Arce: On just for future because I'm sure that's kind of a follow on question.

Antonio Eduardo Arce: We would look to fund any future purchases through discretionary purchase repurchases through our cash flows.

Antonio Eduardo Arce: And not through.

Antonio Eduardo Arce: Whats the cash on hand, and it's at the Board's discretion. So we'll report out more buys as we go here, but 18.4 through the end of April.

Antonio Eduardo Arce: Helpful. Thank you.

Antonio Eduardo Arce: Thanks, Joe.

Antonio Eduardo Arce: Thank you next question is coming from Ed Arce from H C. Wainwright. Your line is now live.

Antonio Eduardo Arce: Hi, good morning. Thanks for taking my questions. Just a couple here. I wanted to follow up again really on the bigger picture here, in particular with the the updated label. I gather you've got the main, The main aspects of that you've got into this new label in particular I wanted to have you speak a little bit further Peter if you could on your view of that the impact of that label particularly longer term persistence and Doctors eventually treating this as a long-term treatment Along with the Know the Signs campaign, which in particular targets the rheumatologists, which have been the lower prescribing group of the two, just broad throts on the longer-term perspective and impacts of those.

Antonio Eduardo Arce: Hi, good morning, Thanks for taking my questions.

Antonio Eduardo Arce: Just a couple here wanted to follow up again.

Antonio Eduardo Arce: Really on the bigger picture here.

Antonio Eduardo Arce: In particular with the updated label.

Antonio Eduardo Arce: I gather you got me.

Antonio Eduardo Arce: The main aspects of that you've got into this new label in particular I wanted to speak.

Antonio Eduardo Arce: Speak a little bit further Peter if you could on your view of.

Antonio Eduardo Arce: The impact of that label, particularly longer term persistence and doctors are eventually treating this as a long term.

Antonio Eduardo Arce: Treatment.

Antonio Eduardo Arce: Along with <unk>.

Antonio Eduardo Arce: No the signs campaign, which.

Antonio Eduardo Arce: In particular targets Rheumatologists.

Antonio Eduardo Arce: Which have been the lower prescribing group broke the two just broad brush.

Antonio Eduardo Arce: On the longer term perspective, and an impact of those.

Peter S. Greenleaf: Well, I'm sure it wasn't missed by anybody. But over the last couple of quarters, we've actually seen improvement in terms of our persistency. And at least from my history of doing this for a little while on multiple drugs, persistency is a really hard thing to move. You know, in the biologics category, when we launched anti-TNF, I remember those numbers staying fairly consistent for a very long time, no matter how much money we threw at them. And I think here, you know, we were sort of right below 50%.

Antonio Eduardo Arce: Well.

Peter: Sure It wasn't missed on anybody but over the last couple of quarters, we've actually seen improvement in terms of our persistency and.

Peter S. Greenleaf: At least from my history of doing this for a little while and multiple drugs.

Peter S. Greenleaf: Assistance. He is a really hard thing to move.

Peter S. Greenleaf: Biologics category, when we launched anti TNF remember those numbers.

Peter S. Greenleaf: Paying fairly consistent for a very long time, no matter, how much money, we throw at it and I think here, we were sort of right below 50%, we inched up to 50% in one.

Peter S. Greenleaf: One year and now we're at 56% so on a macro level I think having this data out there that shows that at least this C&I can be used. This next generation C&I can be used for longer periods of time is incredibly helpful. I think along side of that the guidelines are now very vocal about aggressive diagnosis.

Peter S. Greenleaf: We inched up to 50% one year, and now we're at 56%. So, you know, on a macro level, I think having this data out there that shows that at least this CNI can be used, this next generation CNI can be used for longer periods of time, is incredibly helpful. I think alongside of that, the guidelines are now very vocal about aggressive diagnosis and earlier treatment. They've always been fairly consistent about levels and needing treatment, but now they're very clear.

Peter S. Greenleaf: Yes.

Peter S. Greenleaf: Earlier treatment.

Peter S. Greenleaf: They've always been fairly consistent about levels and needing treatment, but now they're there they're very clear and you actually have companies and investment going into educating and making sure that people start to actually put these guidelines into play so.

Peter S. Greenleaf: And you actually have companies and investment going into educating and making sure that people start to actually put these guidelines into play. So, you know, for the longer term, the bigger picture question, we need to see more aggressive diagnosis in the rheumatologist's office. We need to see target levels of proteinuria treated by rheumatologists when there are signs. And this is not just Aurinia's goal.

Peter S. Greenleaf: For the longer term the bigger picture question, we need to see more aggressive diagnosis and the rheumatologist office, we need to see target levels of proteinuria treated by Rheumatologists.

Peter S. Greenleaf: This is the goal of the treatment guidelines, and then those treatment guidelines estimate the patient should be on treatment for an estimated three to five years. So, all of those things have a significant level of improvement that can happen. And I think that's what's going to move this whole category to a much larger opportunity for the industry. And I also think it's going to take the burden of disease for the patients we're trying to care for here and take it down dramatically. So, that's kind of the big picture view, at least as we see it, Ed.

Peter S. Greenleaf: When there are signs and this is not just Iranian goal. This is the goal of the treatment guidelines and then those treatment guidelines estimate the patient should be on an estimated three to five years. So all of those things have significant level of improvement that can that can happen.

Antonio Eduardo Arce: Great, that's helpful. A couple more, if I may.

Antonio Eduardo Arce: And I think that's what's going to move this this whole category to a much larger opportunity for the industry and I also think it's going to take the burden of disease for the patients we're trying to care for here and take it down dramatically. So that's.

Antonio Eduardo Arce: That's kind of a big picture view at least as we see it.

Ed: Great that's helpful.

Peter S. Greenleaf: Just one question on AUR200. You mentioned that remains a very interesting target, the April bath inhibitor. I'm just wondering if you have any... (inaudible) News Flow near term with that. And then last question, wanted to ask about the comment about the newer, higher expectations for the kind of pricing, 70 to 75 versus the 65 previously. What is it that you think has persisted and changed your view from...

Ed: A couple more if I may just one question on EUR 200.

Peter S. Greenleaf: You mentioned that.

Peter S. Greenleaf:

Peter S. Greenleaf: It remains.

Peter S. Greenleaf: You know a very interesting target the April Bath inhibitor I was just wondering if you have any.

Peter S. Greenleaf:

Peter S. Greenleaf: Particular.

Peter S. Greenleaf: Relevant timelines or anything you can share in terms of.

Peter S. Greenleaf: News flow.

Peter S. Greenleaf: Near term with that and then last question wanted to ask about the <unk>.

Peter S. Greenleaf: The comment about that.

Peter S. Greenleaf: Newer higher expectation for loop kind of pricing 70 to 75 versus the 65 previously.

Peter S. Greenleaf: What is it that you think has persisted and changed your view from.

Peter S. Greenleaf: Prior expectation.

Speaker Change: Thanks again.

Peter S. Greenleaf: Yeah, I'll take the first one and then I'll, Joe, kind of give his two cents on the 70 to 75 on average net. Listen, I think just to give the most updated information that we have on it, AUR200, the IND was approved by the U.S. FDA. So we are ready to start SADMAD studies. And, you know, we'll, as I said on the call, our goal is to keep this thing moving forward.

Speaker Change: Yeah I'll take the first one and then I'll have Joe kind of give his two cents on the 70 to 75 average net.

Peter S. Greenleaf: Listen I think just to give the most update information that we have on at EUR 200, <unk> was approved by the U S. F D. A.

Peter S. Greenleaf: So when we actually do have a path, whether it's internally or externally forward, we understand that getting clear about how long those SADMAD studies will take, when you're going to have your first human clinical studies, and when you should expect to see phase two data, phase three data, et cetera, and in what indications soon. So, you know, I would earmark that one for a future call but know that the IND has been approved by the U.S. FDA and we're moving into animal tox and SADMAD studies this year, either through Aurinia or through an external party. So the pricing question; let me kick that to Joe. [inaudible]

Joe: So we are ready to start sad Mad studies.

Peter S. Greenleaf: And.

Joe: As I said on the call. Our goal is to keep this thing moving forward. So when we actually do have a path, whether it's internally or externally forward, we understand that getting clear about how long those sad Mad studies will take when youre going to have your your first in human clinical studies and when you should expect.

Joe: Back to see phase II data phase III data et cetera, and in what indications soon so I.

Joe: I would earmark that one for a future call, but note that the IND has been approved by the U S. FDA and we're moving into animal Tox and in the Sad Mad studies, this year, either through or radio or through an external party. So.

Peter S. Greenleaf: The pricing question, let me, let me kick that to Joe.

Joseph M. Miller: Yeah, to follow up on your pricing question, there are kind of two factors. One is, obviously, Peter already touched on it, which was the persistency itself, which has evolved kind of considerably over time.

Joe: Yeah to follow up on your pricing question I think it's kind of two factors. One is obviously Peter already touched on it which was the persistency itself that has evolved kind of considerably over time I think if you look back Q1 of 'twenty three it was about 51% at 12 months. It's now moved to 56% at 12 months. So that's probably your largest driver for the.

Joseph M. Miller: I think if you look back, in Q1 of 23, it was about 51 percent at 12 months. It's now moved to 56 percent at 12 months. So that's probably your largest driver for the evolution of the net revenue per patient estimate. Also, coupled into that is some small price increases over time that have kind of inched.

Joseph M. Miller: <unk> of the net revenue per patient estimate also coupled into that as some small price increases over time that if I kind of inched up that number on average.

Joseph M. Miller: Thank you. The next question is coming from David Martin from Bloomberg, and your line is now live.

Joseph M. Miller: Thank you. Our next question is coming from David Martin from Bloom Burton Your line is now live.

David C. Martin: Yes, good morning. Thanks for taking my questions. First off, also going back to the updated Loop Kindness label, is there any part of that that could give rise to new patent claims, do you think, or is everything related to the change already in your existing patents?

David C. Martin: Yes. Good morning, Thanks for taking my questions.

David C. Martin: First off also going back to the updated loop kind US label is there any part of that that could give rise to new patent claims do you think or is everything related to the change already in your existing patents.

Peter S. Greenleaf: Well, as we've mentioned previously, David, we have patents on file with the U.S. FDA that have not been, or the U.S. Patent and Trade Office that have not been publicly disclosed and won't be until we actually get some action, whether it's an acceptance of the patents or not. I can tell you that regardless of the U.S. label change, and the U.S. label can be helpful to those patents in terms of orange book listing, we started looking at that back when we unearthed the data from the extension study in general.

David C. Martin: Well as we've mentioned previously David we have patents on file with the U S. FDA that have not or the U S patent and trade office that have not publicly disclosed and won't be until we actually get some action whether it's an acceptance.

Peter S. Greenleaf: The patents are not.

Peter S. Greenleaf: I can tell you that regardless of the U S label change in the U S label can be helpful to those patents in terms of Orange book listing.

Peter S. Greenleaf: We started looking at that back when we on our date.

Peter S. Greenleaf: The data from the extension study in general and I would just leave you with no debt on it follows sort of that line of.

Peter S. Greenleaf: And I would just leave you with know that it follows sort of that line of possibility in terms of those patents that are on file with the U.S. FDA. So the short answer is yes, but we haven't had a readout from the U.S. PTO yet.

Peter S. Greenleaf: Possibility in terms of those patents that are on file with the U S. FDA. So the short answer is yes, but we havent had a readout from the U S PTO yet.

David C. Martin: Got it. Second question, with restarts becoming more important and trending up, do you have any idea what percent of patients have the proteinuria rebound after coming off leukemias and how long does it typically take for that rebound to occur?

Speaker Change: Got it.

Peter S. Greenleaf: Second question with restarts, becoming more important and are trending up.

David C. Martin: Do you have a read on what percent of patients have the protein area rebound after coming off with kindness and how how long does it typically take for that rebound to occur.

Peter S. Greenleaf: The short answer is, and I would look to Greg if he's got a clinical answer to this, you know, I think the data is emerging on this in terms of what we know internally, in terms of seeing the percent of the patients come back. I'm not sure that we have a quantitative read as to how long that takes and what those proteinuria levels are. What we do know is, unfortunately, the disease, and this isn't a lupokinase issue. This is an MMF issue.

David C. Martin: The short answer is no.

Peter S. Greenleaf: And I would look to Greg if he's got a clinical answer to this.

Peter S. Greenleaf: I think the data is emerging on this in terms of what we know internally in terms of seeing the percent of the patients come back I'm not sure that we have a quantitative read as to how long that takes and what those proteinuria levels are what we do know is unfortunately, the disease and this isn't.

Peter S. Greenleaf: Loeb kindness issue. This is an MMF issue. This is a little kindness issue. It's any drug that comes after us until we get more alignment to treatment guidelines that it's treated episodically and that when patients are and some of this might be due to the fact that historical drugs had a lot of toxicity alongside of them that they used to treat the disease.

Peter S. Greenleaf: This isn't just a lupokinase issue. It's any drug that comes after us until we get more alignment to treatment guidelines so that it's treated episodically. And that when patients, and some of this might be due to the fact that historical drugs had a lot of toxicity alongside them that they used to treat the disease. So, you know, trying to treat it intermittently was a pattern that was just derived from trying to manage, you know, these potentially toxic drugs that were being put on the patients. But the short answer is that we see this continuing to be an opportunity as we shift the market more aligned to guidelines. Greg, what would you add?

Greg: So you know trying to intermittently treat.

Greg: It was a pattern that was just derived from trying to manage these.

Peter S. Greenleaf: These these potentially toxic drugs that were being put on the patients but the short answer is we see this as continuing to be an opportunity as we shift the market more aligned to guidelines Greg It what would you what would you add.

Greg Keenan: But, excuse me, at the end of our Aurora program, we monitored patients for four weeks, and there was stability with regard to the patient's response in terms of proteinuria for the subsequent four weeks. Thereafter, I certainly agree with you, Peter, that different individuals will have recurrence at different points, and I'll just emphasize one thing. The opinion leaders in this area indicate, like you are implying, this is a chronic disease, not an episodic disease, irrespective of how clinicians treat it, and hence, the recommendation is to maintain treatment once they secure a response is important.

Peter S. Greenleaf: But.

Greg: Excuse me at the end of our Aurora program, we monitored patients for subsequent four weeks and there was stability with regard to the patient's response in terms of proteinuria for the subsequent four weeks thereafter, I certainly agree with you Peter.

Greg Keenan: Different individuals will have recurrence at different points. So I'll just emphasize one thing the opinion leaders in this area indicate like you are implying this is a chronic disease not an episodic disease irrespective about how clinicians treat it and hence the recommendations to maintain treatment once they secure response is important.

Operator: Thank you. We've reached the end of our question and answer session. I'd like to turn the call back over to management for any further closing comments.

Speaker Change: Thank you we've reached end of our question and answer session I would like to turn the floor back over to management for any further closing comments.

Peter S. Greenleaf: I want to thank everybody for their time today. I look forward to updating you as we move into the second quarter. Have a great day.

Speaker Change: I want to thank everybody for their time today and look forward to updating you as we move into the second quarter.

Speaker Change: Good day.

Operator: Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

Speaker Change: Thank you that does conclude today's teleconference and webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.