Q2 2025 Aurinia Pharmaceuticals Inc Earnings Call
Conference Operator: Good evening and welcome to the Aurinia Pharmaceuticals Inc. second quarter 2025 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 zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Joe Miller, Chief Financial Officer for Aurinia. Thank you. You may begin.
Greetings and welcome to the aura near pharmaceutical second quarter 2025 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 zero on your telephone keypad. As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host, Joel Miller, Chief Financial Officer for Aurinia. Thank you. You may begin.
Joe Miller: Thank you, Operator, and thank you, everyone, for joining today's call and webcast. Joining me on the call this morning are Peter Greenleaf, Aurinia's President and Chief Executive Officer, and Dr. Greg Keenan, Aurinia's Chief Medical Officer. Today, we will review and discuss Aurinia's second quarter 2025 financial results and provide an update on recent corporate progress, as communicated in the company's press release and quarterly report on Form 10-Q issued this morning. For more information, please refer to Aurinia's filings with the U.S. Securities and Exchange Commission and Canadian Securities Authorities, which are also available on Aurinia's website at auriniapharma.com. During today's call, Aurinia may make forward-looking statements based on current expectations. These forward-looking statements are subject to a number of significant risks and uncertainties, and actual results may differ materially.
Thank you, operator. And thank you everyone for joining. Today's call on webcast. Joining me on the call this morning are Peter Greenleaf Arenas. President, Chief, Executive Officer and Dr. Greg Keenan areni is chief medical officer.
Today, we will review and discuss Aurinia Pharmaceuticals Inc.'s second quarter 2025 financial results and provide an update on recent corporate progress. As communicated in the company's press release and quarterly report on Form 10-Q issued this morning.
For more information, please refer to our renia's filings with the US Securities and Exchange Commission and Canadian Securities authorities which are also available on arin's website at aurinia.
During today's call, Aurinia may make forward-looking statements based on current expectations.
These 4 looking statements are subject to a number of significant risks and uncertainties and actual results May differ materially.
Joe Miller: For discussion of factors that could affect Aurinia's future financial results and business, please refer to the disclosures in Aurinia's press release, quarterly report on Form 10-Q, and all other 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, July 31st, 2025, unless otherwise noted and are based upon information currently available to us. Except as required by law, Aurinia assumes no obligation to update any such statements. Now, let me turn the call over to Aurinia's President and CEO, Peter Greenleaf. Peter.
For discussion of factors that could affect the renia's future Financial results and business. Please refer to the disclosures in aurinia. Press release quarterly report on form 10q and all other filings with the US Securities and Exchange Commission and Canadian Securities authorities.
2025, unless otherwise, noted and are based upon information currently available to us,
Except as required by law, aurinia assumes. No obligation to update any such statements.
Now, let me turn the call over to Iranian president and CEO Peter Greenleaf Peter.
Peter Greenleaf: Thanks, Joe, and good morning, everyone. I want to thank everybody for joining us today. On this morning's call, I will provide an update on our second quarter results and provide an update on all corporate initiatives. I will then turn the call back over to Joe to provide additional detail on our financial results. We continue to achieve strong growth in total revenue and net product sales in the three and six months ended June 30th, 2025. For the three and six months ended June 30th, 2025, total revenue was $70 million and $132.5 million, up 22% and 23% respectively, from $57.2 million and $107.5 million respectively in the same periods of 2024.
Thanks, Joe, and good morning everyone. I want to thank everybody for joining us today on this morning's call I'll provide an update on our second quarter results and provide an update on all corporate initiatives. I'll then turn to call back over to Joe to provide additional detail on our financial results.
We continue to achieve strong growth in total revenue and net product sales in the 3 and 6 months ended June 30th 2025.
For the 3 and 6 months ended June 30th, 2025 total revenue, was 70 million and 132.5 million up 22% and 23% respectively.
From 57.2 million and 107.5 million respectively, and the same periods of 2024.
Peter Greenleaf: For the three and six months ended June 30th, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, or LN, were $66.6 million and $126.5 million, up 21% and 23% respectively, from $55 million and $103.1 million in the same periods of 2024. The increase for both periods is primarily due to an increase in the number of LUPKYNIS cartons sold to specialty pharmacies, driven by further LN market penetration. For the six months ended June 30th, 2025, cash flow generated from operations was $45.5 million. This is compared to a negative $2.8 million in cash flow used in operations in the same period of 2024. Excluding $11.5 million in cash payments made in 2025 in connection with the November 2024 restructuring, cash flow generated from operations was $57 million for the six months ended June 30th, 2025.
Developers of fris or Ln were 66.6 million and 126.5 million.
Up, 21% and 23% respectively.
From 55 million, and 103.1 million in the same periods of 2024.
The increase for both periods is primarily due to an increase in the number of lupinus carton sold to Specialty, pharmacies driven by further Ln Market penetration,
For the 6 months, ended June 30th 2025 cash flow, generated from operations was 45.5 million.
This is compared to a negative -22.8 million in cash flow used in operations in the same period of 2024.
Excluding $11.5 million in cash payments made in 2025 in connection with the November 2024 restructuring, cash flow generated from operations was $57 million for the 6 months ended June 30, 2025.
Peter Greenleaf: As of June 30th, 2025, we have cash, cash equivalents, restricted cash, and investments of $315.1 million. This is compared to $358.5 million at December 31st, 2024. For the six months ended June 30th, 2025, the company repurchased $11.2 million of its common shares for $90.8 million, including commissions and excise tax. As a result of the sustained growth we have seen in the first half of 2025, we are increasing our full-year 2025 total revenue guidance from a range of $250 million to $260 million to a range of $260 million to $270 million, and our net product sales guidance from a range of $240 million to $250 million to a range of $250 million to $260 million. Finally, we reported positive results from our AUR200 phase one single ascending dose study on June 30th, 2025. AUR200 is a dual BAFF-APROL inhibitor.
As of June 30th 2025, we have cash, cash, equivalents restricted, cash and Investments of 3315.1 million.
This is compared to 358.5 million at December, 31st 2024.
For the 6 months, ended June 30th, 2025 the company. Repurchased, 11.2 million of its common shares for 90.8 million, including commissions, and excise tax.
As a result of the sustained growth, we've seen in the first half of 2025, we are increasing our full year. 2025 total revenue guidance from a range of 20050 to 260 million
To a range of 260 million to 270 million.
And our net product sales guidance from a range of 240 million, to 250 million, to a range of 250 million to 260 million.
Finally, we reported positive results from our our attenders set, Phase 1, single ascending dose study on June 30th 2025,
Peter Greenleaf: It contains a BCMA-engineered extracellular binding domain that is optimized for superior affinity to APROL and BAFF. We remain on track to initiate further clinical studies for AUR200 in at least two autoimmune diseases in the second half of this year. We are very excited about the wide range of therapeutic possibilities for AUR200, but for competitive reasons, will not be disclosing further detail about our future plans at this time. I would now like to turn the call back over to Joe for a more detailed review of the second quarter 2025 financial results. I will then return at the end of the call for a quick recap and to open up the line for any questions you might have. Joe?
Our its intercept is a dual bath April. Inhibitor it contains a bcma, engineered, extracellular, binding domain. That's optimized for Superior, Affinity to April and bath.
We remain on track to initiate further, clinical studies, for our intercepts, and at least 2 autoimmune diseases, in the second half of this year.
We are very excited about the wide range of therapeutic. Possibilities for our intercept, but for competitive reasons, will not be disclosing. Further detail about our future plans at this time.
I'd now like to turn the call back over to Joe for more detailed review of the second quarter 2025 Financial results. I'll then return at the end of the call for a quick recap and to open up the line for any questions you might have.
Joe.
Joe Miller: Thank you, Peter. Let's take a few minutes to discuss the second quarter 2025 financial results. For the three and six months ended June 30th, 2025, total revenue was $70 million and $132.5 million, up 22% and 23% respectively, from $57.2 million and $107.5 million in the comparable periods of 2024. As Peter mentioned, we had cash, cash equivalents, restricted cash, and investments of $315.1 million as of June 30th, 2025, and generated cash flows from operations of $45.5 million compared to $2.8 million in cash flow used in operations in the same period of 2024. Excluding $11.5 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $57 million for the six months ended June 30th, 2025.
Thank you, Peter. Let's take a few minutes to discuss the second quarter 2025 financial results.
For the 3 and 6 months ended June 30th, 2025 total revenue, was 70 million and 132.5 million up 22% and 23% respectively from 57.2 million and 107.5 million in the comparable periods of 2024.
As Peter mentioned, we had cash cash, equivalents restricted cash and Investments of 315.1 million as of June 30th 2025 and generated. Cash flows from operations of 45.5 million compared to 2.8 million in cash flow used in operations in the same period of 2024.
Joe Miller: We are continuing to be opportunistic with our share repurchase plan and expect to fund any future discretionary share repurchases with cash flows from operations and cash currently on hand. The company repurchased $18.3 million of its common shares for $138.4 million, excluding commissions and excise tax, since the launch of the program in the first quarter of 2024 through today. Additionally, today we announced that the board has approved an increase to the share repurchase plan of up to an additional $150 million of common shares over the initially approved $150 million board authorization. For the three and six months ended June 30th, 2025, the cost of revenue was $7.1 million and $15.7 million, respectively, compared to $8.9 million and $16.7 million in the comparable periods in 2024.
Excluding 11 and 1.5 million of cash payments made in connection with the November 2024, restructuring cash, flow generated from operations, was 57 million for the 6 months. Ended June 30th 2025
We are continuing to be opportunistic with our share repurchase plan and expect to fund any future. Discretionary share repurchases with cash flows from operations and cash currently on hand.
The company repurchased, 18.3 million of its common shares for 138.4 million excluding commissions and excise tax.
To launch the program in the first quarter of 2024 through today.
Additionally, today, we announced that the board is
an increase of the share repurchase plan of up to an additional 150 million of common shares over the initially approved, 150 million board. Authorization,
Joe Miller: The decrease for both periods is primarily due to a decrease in sales of LUPKYNIS inventory to Atsuka, which is sold under a cost-plus arrangement and has a lower gross margin than our other LUPKYNIS sales. For the three and six months ended June 30th, 2025, gross margin was 90% and 88% respectively, compared to 84% and 85% in the same periods in 2024. For the three and six months ended June 30th, 2025, total operating expenses were $49.9 million and $90.5 million, respectively, compared to $58.7 million and $122.3 million in the comparable periods of 2024. The decrease for both periods is primarily due to lower personnel expenses, including share-based compensation and overhead costs, as a result of our strategic restructuring efforts in 2024.
For the 3 and 6 months, ended June 30th, 2025 cost of Revenue was 7.1 million and 15.7 million respectively, compared to 8.9 million, and 16.7 million in the comparable periods in 2024.
The decrease for both periods is primarily due to a decrease in sales of loop, kindness inventory to atssa which is sold under a Cost Plus Arrangement, and has a lower gross margin than our other loop kind of sales.
30th, 2025, gross margin was 90% And 88%, respectively, compared to 84% and 85% the same periods in 20124.
For the 3 and 6 months ended June 30, 2025, total operating expenses were $49.9 million and $90.5 million, respectively, compared to $58.7 million and $122.3 million in the comparable periods of 2024.
Joe Miller: This was partially offset by an increase in R&D-related expenses as we continue to advance our development activities for R-itinercept and Vacosporin and other non-cash expenses related to the remeasurement of our Swiss franc-denominated monoplant finance lease liability and changes in our fair value assumptions related to our deferred compensation liability. For the three months ended June 30, 2025, net income was $21.5 million, or $0.16 of earnings per share, compared to $722,000, or $0.01 of earnings per share in the same period of 2024. For the six months ended June 30, 2025, net income was $44.9 million, or $0.33 of earnings per share, compared to a net loss of $10 million, or $0.07 net loss per share in the same period of 2024. With that, I would like to hand the call back over to Peter for some closing remarks. Peter?
the decrease for both periods is primarily due to lower Personnel expenses, including shared, base compensation, and overhead costs as a result of our strategic restructuring efforts in 2024,
This was partially offset by an increase in R&D related expenses as we continue to advance our development activities for our tennis cept and vocal sporting, and other non-cash expenses related to the remeasurement of our Swiss franc denominated model plant Finance lease liability and changes. In our fair value, assumptions related to our deferred compensation liability.
For the three months ended June 30, 2025, net income was $21.5 million, or $0.16 of earnings per share, compared to $722,000, or $0.01 of earnings per share, in the same period of 2024.
For the six months ended June 30, 2025, net income was $44.9 million, or $0.33 of earnings per share, compared to a net loss of $10 million, or $0.07 net loss per share, in the same period of 2024.
with that, I'd like to hand the call back over to Peter for some closing remarks Peter
Peter Greenleaf: Thanks, Joe. In summary, we continue to drive growth in the commercial LUPKYNIS business, move forward with the clinical development of AUR300, and maintain excellent operational efficiency. I want to thank you all for your time today. We will now open the lines for any questions you may have. Operator?
Thanks. Joe, in summary, we continue to drive growth in the commercial loop. Kindness business moves forward with the clinical development of our retainers and maintain excellent operational efficiency.
I want to thank you all for your time today. We'll now open the lines for any questions. You may have operator,
Operator: Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the headset before pressing the star keys. One moment, please, while we pull for questions. Our first question comes from the line of Stacy Ku with TD Cowen. Please proceed with your question.
Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press *1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press *2 to remove yourself from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.
1 moment, please while we pull for questions.
Our first question.
Comes from the line of Stacey Q with TV, calling please proceed with your question.
Analyst (various, see below): Thanks. Hi, team. This is Vish An for Stacy Ku. Congrats on a great quarter, and thanks for taking our questions. You reported some encouraging data for AUR200, and I understand that you are not, for competitive reasons, disclosing any details. But could you at least guide us through how you are thinking about the potential for AUR200? Where do you think it could generate or add the most value so that us and investors could appreciate how you are thinking about the development? Based on the PKPD data from the SAD study, how are you thinking about maybe potentially doses to be moved forward for the POC studies? Thanks, and I have one follow-up.
Thanks. Hi team. This is Vish on first AC, congrats on a great quarter and thanks for taking our questions. So you reported some encouraging data for our tenor steps and I understand that you're not um, for competitive reasons, disclosing any details, but could you at least guide us to how you were thinking about the potential for Arts intercept, where do you think it could generate or add the most value so that us and investors could appreciate how you're thinking about the development.
Um, and based on the pkpd data from the side study, how are you thinking about maybe potentially doses to be moved forward for the PC studies? Um, thanks and I have 1 follow up
Peter Greenleaf: Yeah, I mean, I'll start, and I'll ask Greg to jump in where I might miss or where he sees some add-on here. Listen, I think the potential of these B-cell-mediated diseases and AUR300's potential ability to affect these B-cell-mediated diseases is apparent today, obviously, in the data that's been rolled out in areas like IGAN. You know, we, as a company, have done our own assessment internally. We think there's upwards of 20 to north of 20 different B-cell-mediated diseases that you could look at, potentially, for these compounds. So while we're not disclosing exactly where we're going in our exact approach for competitive reasons at this stage, know that we see a pretty wide-open field in terms of other areas that could potentially be addressed, even outside of the kidney indications that have been explored to date.
Yeah, I mean I'll start and I'll, I'll ask Greg to jump in where, where I might miss or where where he he sees, uh, some add-on here. Listen. I I think the potential of, uh, these B cell mediated diseases, and, and April, based, potential ability, to affect these B cell mediated diseases is apparent today. Obviously, in the data that's been rolled out in areas like Ian, um, but you know, we as a, uh, as a company have done, you know, our own in assessment internally, we we think there's upwards of 20 to to north of 20 different B cell mediated diseases that you could look at for um uh you know potentially for these uh for these compounds. So while we're not disclosing exactly where we're going in our exact approach for competitive reasons at this stage know that um we see a a pretty wide open field in terms of other areas that could potentially be addressed.
Peter Greenleaf: So we'll look forward to talking more about that in the future. At this point, as we've said, we're not disclosing for competitive purposes, but know we're looking at a range of indications. Greg, you want to talk maybe a little bit about the dose side of the single ascending dose study?
Um, even outside of, um, you know, the kidney, uh, indications that have been explored to date, uh, so we'll look forward to talking more about that in the future. But at this point, as we've said, um, we're not, we're not disclosing for competitive purposes, but no, we're looking at a range of indications. Um, Greg, you want to talk maybe a little bit about the the Dose side of the single ascending, uh, dose study.
Greg Keenan: Sure. Thank you, Peter. Yes. Based on the evidence from the single ascending dose study, we're very confident now that a Q4-week dosing schedule is justified with the evidence, especially with regard to kinetics, the pharmacokinetics, and the pharmacodynamics that we've demonstrated with a single ascending dose. So we think Q4-week dosing will be something we can explore and confidently be able to demonstrate some important evidence as we move forward into the multiple ascending dose studies.
Q4e dosing will be um uh something we can explore and confidently, be able to uh demonstrate some important evidence. Uh as we move forward into the multiple setting dose studies.
Analyst (various, see below): Got it. Thank you. My follow-up was on LUPKYNIS. Clearly, the sales are doing well, and you are raising guidance. Can you just detail some effects that you are seeing of the updated ACR guidelines on LUPKYNIS adoption? Maybe discuss how rheumatology versus nephrology prescribing is going and what that looks like right now. Thanks.
Got it. Thank you and then my follow-up was on the kindness actually. Um, clearly the sales are doing well and you're raising guidance. So can you just detail some effects that you are seeing of the updated ACR guidelines on? What kind of adoption? Um, maybe discuss how Rheumatology versus neurology prescribing is going, um, and and what that looks like right now, thanks,
Peter Greenleaf: Yeah, I think we're encouraged by the guidelines. I think two evidence points I would give you that the guidelines are having some impact, albeit they're not quantitative. They'll give you a directional feel for how they're impacting our business. We've seen a really strong uptick in the number of rheumatology prescribers. The guidelines themselves, alongside of, we've got the two-year extension of the original Aurora study that's been out there. We had the biopsy sub-study that was published in a rheumatology journal. I think that, in combination with the guidelines, has driven higher prescribing that we're seeing in rheumatology offices, so an increase there. In addition, we're seeing an increase in our hospital business. I think that's a direct reflection of the academic setting and fellows and teaching institutions adopting those guidelines and using them more proactively.
Yeah, I think we're encouraged by the guidelines and I think, 2 evidence points, I guess I would give you that. Uh, the guidelines are having some impact albeit, they're not quantitative. Um, they'll give you a directional feel for, um, how they're impacting our business. Um, we've seen a really strong uptick in the number of of Rheumatology prescribers. I mean, the the guidelines themselves alongside of, you know, we've got uh, you know, the 2 year, extension of the original Aurora study that's been out there, we had the biopsy sub study that was published in a Rheumatology Journal. I think that in combination with the guidelines has driven, um, higher prescribing um, that we're seeing in Rheumatology offices. So an increase there. And then in addition, we're seeing an increase in our Hospital business and I think that's a direct reflection of, um, you know, the academic setting and
Peter Greenleaf: While it's not a quantitative answer, it can give you a really good feel for how we think they're impacting. Rheumatologists are using more of our drug. They're growing at a faster rate than nephrologists right now. In addition, our hospital business has been growing in a healthy way since the guidelines have been published.
And, you know, fellows and and, and teaching institutions, um, you know, adopting those guidelines and using them more proactively. So while it's not a quantitative answer, it can give you a really good feel for, um, how we think they're impacting. R rumatologist are using more of our drug. They're growing at a faster rate than neurologists right now. And then in addition, our Hospital business has been growing in a healthy way. Since the guidelines have been published
Analyst (various, see below): Got it. Thank you very much.
Got it. Thank you very much.
Peter Greenleaf: Thanks, Vish.
Operator: Thank you. Our next question comes from the line of Maury Raycroft with Jefferies. Please proceed with your question.
Thank you.
All right. Next question comes from the line of my recraft with Jeffrey's. Please proceed with your question.
James Zahn: Hi. This is James Zahn from RBC Capital Markets. Congrats on the progress, and thank you for taking our questions. Just another question on LUPKYNIS, and then I have a follow-up question. For the raised guidance, can you talk more about the drivers and what you are seeing from new patient starts and hospital restarts trends in the initial four weeks in Q3 and learning some prior summer months that informs your commercial outlook for 2025?
Hi. This is James on from war, congrats on the progress, and thank you for taking our questions. Just another question on luk kindness and I have a follow-up question. Uh, for the, for the raise guidance. Can you talk more about the drivers and what you're seeing from new patient starts and Hospital restarts, uh, Trends in the initial for a 4 weeks in 3Q and learning some prior summer months, that informs your commercial outlook for 2025.
Peter Greenleaf: I want to start, and Joe, if I miss anything, please jump in. I think the best way to think about our guidance range is, on the lower end to the midpoint of our revised guidance, you would have to see either a flattening of our business or a declining of our business in the summer months and back to growth in the back half of the year. The higher end of our guidance range is continued growth through Q3 and Q4. If you look historically, James, at how our sales have progressed, as we have said on previous calls, we now think history is probably the best way to predict how this business moves forward. The summer months have, we have seen a slowing in some of our metrics.
Yeah, I want to start and that Joe, if I miss anything, please jump in. I so
I think if the best way to think about our guidance range is, you know, on the lower end to the midpoint of our, our revised guidance. Um, you'd have to see either a flattening of our business or a declining of our business in the summer months, and back to growth in the back half of the year. Um, the higher end of our guidance range is continued growth, through 3 q and 3 q and 4 q. If you look historically, James at how our sales have have progressed. And as we've said on previous calls, we now think history is probably the best way to predict how this business moves forward. Um, uh,
Peter Greenleaf: In particular, the PSFs have been a little lighter historically in the summer months, and our revenue has been relatively flat to the previous quarter, so flat to Q2 using history. The way we are looking at our guidance range is the low to mid, you see the historical trends. A high to beat above is, you know, we keep growing quarter on quarter, and we are really encouraged by everything we are seeing in the business right now. We are excited to take up the guidance range, and that is kind of how we are thinking about it, James.
The summer months, have we've seen a slowing in some of our metrics, in particular, psfs have been a little lighter, uh, historically in the summer months and our Revenue has been relatively flat to the previous quarter, so flat to 2q, um, using history. So the way we're looking at our guidance ranges the low to mid,
You see the historical Trends, the high to high to beat above is, you know, we keep growing quarter on quarter and we're really encouraged by everything. We're seeing in the business right now. So uh, uh, we're excited to take up the, uh, the guidance range and and that's kind of how we're thinking about it. James.
James Zahn: Got it. Thanks. Then the second one for your BAFF-APROL inhibitor, AUR300. Can you talk more about when we can see the next data update from the MAD phase and more on rare/orphan autoimmune diseases that you aim to pursue? What are the gating factors to picking specific disease settings to pursue? Are you waiting for competitor updates, or is it more related to evolving internal strategy?
Got it. Thanks. Um, and then the second one for your bath April inhibitor, uh, ART intercept. Can you talk more about when we can see the next data update from the MAD phase? Um, and more on rare/orphan autoimmune diseases that you aim to pursue? Um, what are the gating factors to picking specific disease settings to pursue? Or are you waiting for competitor updates, or is it more related to evolving internal strategy?
Peter Greenleaf: Well, I mean, I wouldn't assume that we were waiting, and I wouldn't assume that we're ruminating on any of this. I would say, I would assume we're moving forward. We're just not communicating externally for public reasons exactly what our approach is going to be or the timing of those programs. As we've said, we want to go after at least two B-cell-mediated diseases. We're going to get those enrolling by this year, by the end of this year, and you know we'll look forward in the future to talking more about it. At this stage, that's all we're giving, James.
Um, we were going to get those enrolling by uh, this year, uh, by the end of this year. And uh, you know, we'll look forward uh, in the future to talking more about it. But at this stage that's all we're giving James.
James Zahn: Got it. Thanks for taking our questions. I'll back in the queue.
Got it. Thanks for taking our questions. I'll back in the queue.
Operator: Thank you. Our next question comes from the line of Joseph Schwartz with Leerink Partners. Please proceed with your question.
Thank you.
Our next question comes from the line of Joseph Schwarz with Ling Partners. Please proceed with your question.
Analyst (various, see below): Hey, guys. This is Willan for Joe. Thanks for taking our questions today and congrats on the progress this quarter. I just have one on the B-cell program and then a quick follow-up. On the prior data call, you had mentioned that you were doing some formulation work for AUR200. Is this work still ongoing, or is it going to be completed prior to the initiation of these future studies later this year? Can you just help us understand the point of this formulation work? Is it specifically to do an autoinjector, or what's the ultimate goal here? I have a quick follow-up. Thanks.
Hey guys, this is Will on for Joe, thanks for taking our questions today and congrats to the progress this quarter. So I just have 1 on uh, the the BSL program and then a quick follow-up. So, on the prior data call, you had mentioned that you were doing some formulation work for Aur. 200, is this work still ongoing or is significantly completed prior to the initiation of these future studies later this year? And can you just help us understand? The, the point of this formulation work, is it specifically to do an auto injector or what's the ultimate goal here? And I have a quick follow-up. Thanks.
Peter Greenleaf: As we said on our previous call, Will, our goal would be to try to get it in the most patient-friendly potential formulation and device possible, and that could include an autoinjector. We actually think looking at the doses we've seen to date, the molecular size that we have, we could have the possibility to do that. But obviously, once you're in single ascending dose studies, you're not optimized towards, or at least we haven't to those formulations yet. That's its parallel pathing with the development work that we're doing. Everything points to us being able to, from what we've seen in the single ascending dose and in the preclinical work we've done up to this point, that those goals would be attainable.
Yeah, as we said on our previous call, will our goal would be to try to get it in the most patient friendly, um, uh potential, uh, formulation and, and device possible, and that could include an auto injector. And we actually think, looking at the doses we've seen to date, uh, the molecular size that that we have, we could have the possibility to do that. But obviously, once you're in single ascending dose studies, you, you're not optimized towards or at least, we haven't to those.
Formulation jet. Um, and that's parallel pathing with the development work that we're doing. But everything points to us being able to, uh, from what we've seen in the single ascending dose and in the pre-clinical work we've done up to this point, um, that those goals would be attainable.
Analyst (various, see below): Great. Thank you. Then, just quickly, a question for Joe. As we see the development of AUR200 ramp up, how should we be thinking about R&D spend moving forward? Can you help us put some brackets or kind of general commentary around the cost for these trials? Do you expect to remain cash flow positive during the development of this asset? Thank you.
Great. Thank you. And then just quickly a question for Joe as we see the development of of Aur 200 ramp up, how should we be thinking about R&D, spend moving forward and can you help us put some brackets or kind of General commentary around the cost for these trials and do you expect to remain cash flow positive during the development of this asset? Thank you.
Peter Greenleaf: Thanks for the question, Will. We haven't provided any specific guidance on operating expenses and/or cash flows going forward. Obviously, as we are moving through 2025, the trial costs were fairly manageable, and you would expect, as you kind of move from phase one into two and on, that the costs will increase. As of right now, we're not getting any specific long-term guidance on OpEx, R&D expenses, and/or cash flows. I think that's right, Joe. The only thing I would say is it should be evident to investors that efficient operations and cash flow from operations, however we decide to deploy it, is a priority for us as an organization. That won't change on a go-forward basis.
Thanks for the question. Will we have been providing any specific guidance on operating expenses and or cash flows going forward? Um, obviously as we were moving through 2025, um, the trial costs were fairly manageable and you would expect as you kind of move from Phase 1 into 2 and on to the costs will increase. But as of right now, we're not getting any specific long-term guidance on Opex R&D expenses and or cash flows. Um,
Yeah, I think that's right. Joe and I the only thing I would say is it should be evident to investors that. Um,
8, fishing operations, and cash flow from operations. However, we decided to deploy it; this is a priority for us as an organization, so that won't change on a go-forward basis.
Analyst (various, see below): Great. Thanks for the color and congrats again.
Great. Thanks for the color and congrats again.
Peter Greenleaf: Thanks, Will.
Thanks. Well.
Operator: Thank you. Our next question comes from the line of Arthur He with HC Wainwright. Please proceed with your question.
Thank you.
Our next question comes from the line of Arthur he with h Wayne Wright, please proceed with your question.
Analyst (various, see below): Hey, good morning, guys. Congrats on the BLA raise. I just got two questions regarding the AUR200. Greg, do you guys plan to present the detailed data at any medical conference from the SAD study?
Hey, good morning guys, uh, congrats on the B10 race. Uh, uh, I just got a uh, 2 questions regarding the uh, 200. So, um, so Greg, do you guys plan to present the detailed data at any medical conference uh from the um, sad story?
Peter Greenleaf: Greg, I mean, Greg maybe can talk to what our intentions are. I think he should just appreciate that, obviously, we have ongoing patent work, etc., with the compound. So what's publicly detailed, we would have that ability to do. But stuff that has not yet been publicly talked about, probably not. Greg, any intentions?
Hey Greg, we have I mean, Greg maybe can talk to what our intentions are. I think he should just appreciate that. Obviously, we have ongoing patent work etc with the compound. So, um, what's publicly detailed? We would have that ability to do but um, stuff that has not yet been publicly talked about, probably not Greg any intentions.
Greg Keenan: Nothing more than that, that they will be presented in an upcoming meeting, but we haven't determined which meeting at this point.
Uh, no nothing more than that that they will be presented in an upcoming meeting. But uh, we have an um determined which meaning at this point.
Analyst (various, see below): Okay, gotcha. The second question on the AUR200 is, Peter, I want to gauge at what kind of situation or circumstance you guys would feel comfortable to disclose the information about the details of indication going after for the AUR200. Just curious.
Okay, gotcha. Um and uh uh, the second question on the 200 is so maybe uh Peter. Um, I just want gauge like at what kind of situation or circumstance. You guys would be feel comfortable to uh, discuss the information about the the the details of indication going. After for the 200 just curious.
Peter Greenleaf: The obvious answer is when we move into a certain phase of development, it becomes public information and available on clinicaltrials.gov. That would be my absolute answer. We haven't really discussed it with our board, Arthur, or we have, and we've deduced to conclude that for competitive purposes, obviously, we've got people that are ahead of us and behind us, and we want to hold what we're doing close to the vest and ensure that we don't lead people down the path of exactly what we're doing. We haven't determined yet when we would disclose, but do realize from the line of questioning here and on our previous call that there's a lot of appetite to understand what our plans are.
Board, Arthur or we have. And we've, we've deduced to concluded that. Um, for competitive purposes. Obviously, we've got people that are ahead of us and behind us. And and we want to um, hold what we're doing. Close to close to the vest and ensure that, um, you know, we don't lead people down the path of exactly what we're doing. Uh, we haven't determined yet, um, when we would disclose, but do realize from the line of questioning here and on our previous call, but there's a lot of appetite to not to understand what our plans are.
Analyst (various, see below): Gotcha. Thanks for the update.
Gotcha. Uh, thanks for that and talk to
Peter Greenleaf: Thank you.
You, thank you.
Operator: Thank you. Our next question comes from the line of Doug Meehan with RBC Capital Markets. Please proceed with your question.
Thank you.
Our next question comes from the line of the medium.
RBC Capital markets, please. Proceed with your question.
Analyst (various, see below): Yeah. Good morning, Peter, Joe. Just with respect to paragraph four filers, there is no change there, no change as it stands right now in terms of the exclusivity period and adding pediatric onto that. Any updates?
Yeah, good morning Peter Joe. Um, just with respect to, um, paragraph 4 filers, there's no change there. No changes. It stands right now, in terms of the exclusivity period and adding pediatric onto that uh, any updates.
Peter Greenleaf: No. Just to clarify that the pediatric trial work that we are doing was part of the original filing but was not an extension body of work. The July 2028 worst-case scenario is not inclusive of six months of pediatric exclusivity, Doug. No changes. We still have patents going all the way out to 2037. We still have our method of use patents, and we continue to do more work around both patents and other work in the company to ensure the longevity of LUPKYNIS. I would just reinforce that the longevity of this asset to us is paramount, and that comes to defending the IP that we have around the compound, and it is an A priority for the company. We will update you when we have more to talk about.
No. And, and just to clarify that the Pediatric trial work that we're doing was part of the original filing, but was not an extension body of work. So the July, uh, 2028 worst case scenario, um, you know, is, uh, is not inclusive of uh 6 months of pediatric exclusivity Doug. Um, no.
Peter Greenleaf: As you know, the legal process on ANDA filings and the subsequent patent infringement lawsuits is pretty protracted, so I would not expect to hear weekly updates from us.
Analyst (various, see below): No. Okay. Second question just has to do with the buyback, and you are aggressive there. There is an obvious opportunity today. As we think about the future, though, given the amount that you are likely to spend on the R&D side, being it is going to increase probably fairly materially, will we think that we could see scaled-back buybacks as we think about beyond 2025? I will leave it there.
No changes. Um, we still have patents going all the way out to 2037. We still have our method to use patents and we continue to do more work around both patents and other work in the company to ensure the longevity of lupinus. Uh, I would just reinforce that the longevity of this asset to us is Paramount and, uh, uh, that comes to defending the IP that we have around the, the, the compound. And, um, you know, it's in, it's in a priority for the company. So, uh, we'll update you when, uh, we have more to talk about, um, but as, you know, the legal process on and of filings, and, and the subsequent, um, uh, patent. Infringement lawsuits is pretty protracted. So, I wouldn't expect to hear, you know, weekly updates from us know,
Peter Greenleaf: Yeah, yeah, yeah. Doug, as we've said, it's up to the board's discretion as to how they deploy that cash. Obviously, management gives input to our belief as to what we should do. I would not miss that LUPKYNIS continues to grow for us. The cash flow as we reported in this quarter, if you carry those forward and you carry forward continued growth of LUPKYNIS, the amount of cash flow from operations becomes fairly significant. We are not giving long-term or even mid to short-term guidance on cash flows, but you can do the math. I think it gives us a very unique position as a biotech company in this space to pay our bills. We have cash on our balance sheet. We have cash flows from operations, so we can pay for the things we want to do, continuing to drive LUPKYNIS and developing our pipeline.
Okay. Um, second question, just has to do with the the buyback and you're aggressive there. There's an obvious opportunity today. Um, as we think about uh the future though uh given the amount that you're likely to spend um on the R&D side being, it's going to increase probably fairly materially um when we think that we could see scaled back by backs, um, as we think about, uh, Beyond 2025. I'll leave it there. Yeah, it would be Doug. As we've said, it's up to the board's discretion and uh, you know, as to how they deploy that cash obviously management gives input to our belief as to what we should do. I wouldn't miss that.
Peter Greenleaf: We have the unique ability to either collect more cash on our balance sheet and grow that over time or deploy it towards buying back shares, which is positive for all shareholders. So, while we are not giving anything for 2026, and I do not disagree that, obviously, your R&D expenses go up as you move into further clinical trials, do not miss the fact that, if LUPKYNIS, which we fully believe will continue to grow, grows, our cash flow from operations and our balance sheet are still very, very strong.
Leucine is continues to grow for us and the cash flows. We reported in this quarter. If you carry those forward and you carry forward, continued growth of Lucas, the amount of cash flow from operations is becomes fairly significant. Now, we're not giving long-term or even mid to short-term guidance on cash flows but you can do the math. And I I think it gives us a very unique position as a biotech company in this space to pay our bills. We have cash on our balance sheet, we have cash flows from operations so we can pay for the things we want to do, continuing to drive Loop, kindness, and developing our Pipeline. And we have the unique ability to either collect cash more cash on our balance sheet and grow that over time.
Analyst (various, see below): Great. Thank you.
Or deploy it towards buying back shares which is positive for all shareholders. So I you know, while we're not giving anything for 26 and I don't disagree that obviously your R&D expenses, go up. As you move into further clinical trials, don't miss the fact that, you know, if Lucas, which we fully believe will continue to grow grows our cash flow from operations and our balance sheet are still very, very strong.
Great. Thank you.
Operator: Thank you. This concludes, we have reached the end of the question-and-answer session. This also concludes today's conference. You may disconnect your lines at this time. We thank you for your participation and have a great day.
Thank you.
And this concludes uh we have reached the end of the question and answer session. And this also concludes today's conference and you may disconnect your lines at this time. We thank you for your participation and have a great day.