Aurinia Pharmaceuticals Inc (AUPH) 2024 Q1 法說會逐字稿

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. 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.

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 earning of 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 this morning. For more information, please refer to our various filings with the US Securities and Exchange Commission and applicable Canadian securities authorities, which are also available on Iridium's website at reatapharma.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 our earnings press release, quarterly report on Form 10 Q and its annual report on Form 10 K and all of its recent filings with the US Securities and Exchange Commission and Canadian securities authorities. Please note that all statements made during today's call are current as of today, Thursday, May second, 2024, unless otherwise noted and are based upon information currently available to us, except as required by law, Aurinia assumes no obligation to update any such statements.

Now let me turn the call over to Aurinia's President and CEO, Peter Greenleaf. Peter?

Thanks, Andrea, and good morning, everyone. I want to thank everybody for joining us on today's call. On this morning's call, we will focus on the company's 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 time line towards cash flow positivity.

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 2020 for a range achieved $50.3 million in total net revenue, representing growth of approximately 46% year over year. 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 USD220 million.

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 a UR. 300, we are currently exploring alternative approaches for AUR. 200 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 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. 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, 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 projections.

On the commercial front, we are laser focused on driving live 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 are either restarting loop kinase or receiving it through hot the hospital pharmacy. Together, these total approximately 596 PSS in combination with restarts in hospital sales versus 466 PSF.s in the prior year first quarter, representing substantial year-over-year growth. There were approximately 2,178 patients on the kinase therapy as of March 31st, 2024, in comparison to approximately 1,731 patients as of March 31st, 23rd, 2023 an increase of approximately 26%, and this was driven by overall improvements in all key commercial metrics. Net realizable revenue per patient for loop kinase remains higher than our initial guidance of 65,000 per patient on an annualized basis. 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 $75,000 on an annualized basis from the start of the year through April 28th, 2024, the Company has added approximately 582 PSS and approximately 170 new patients from restarts in the hospital channel. We continued to sustain high conversion rates with approximately 85% of PSS converting to patients on therapy. We also sustained a rapid conversion time with approximately 60% of patients starting therapy within 20 days. Our overall health 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. Our metrics demonstrate continued growth that is driving the upward trajectory of Leukine as 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 loop kinase as a best-in-class drug with a strong clinical portfolio that aligns with the most current treatment guidelines. As announced earlier this week, the FDA has approved a label update for loop kinase. The label no longer includes language indicating that the safety and efficacy of Ruconest has not been established beyond one year for label now includes long-term data from a post-hoc analysis of the AURORA two extension study data showed that patients receiving loop kinase achieve sustained complete renal response at every time point assessed throughout the three years when compared to MMF and low-dose group glucocorticoid steroids alone.

Shifting to our marketing efforts. We recently launched the know the science 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 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 AL end market. 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 cause 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 loop kinase reduce proteinuria roughly three times faster than MMF and steroids 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 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.

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 loop kinase 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 loop kinase to treat adults with active lupus nephritis. Upon approval, we expect to receive a milestone of $10 million and from their low double digit royalties on net sales once launched.

So in summary, we believe our first quarter accomplishments reflect solid execution against our previously announced business priorities. I also want to recognize it 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 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 I did then open the line to any questions that you might have. Joe?

Thank you, Pierre, 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 31st, 2024 and March 31st, 2023, respectively. Net product revenue of 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 live time to sales from our two main specialty pharmacies driven predominantly by further penetration of the L end markets.

Total cost of sales and operating expenses, inclusive of onetime restructuring charge in Q1 2024 were $63.6 million for the quarter ended March 31st, 2024 and $64 million for the quarter ended March 31st, 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. Cost of sales was 7.8 million for the quarter ended March 31st, 2024, and 421,000 for the quarter ended March 31st, 2023. The increase is primarily due to increased sales of book kinase, coupled with the amortization of the mono plant finance right-of-use asset, which was placed into service in late June 2023. Gross margins for the quarter ended March 31st, 2024 and March 31st, 2023 was 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 31st, 2024 and March 31st, 2023, respectively. 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 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 charges reflected as a standalone or line item in the profit and loss statement and will be discussed separately in a moment, 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 was 5.6 million for the quarter ended March 31st, 2024, and $13.2 million for the quarter ended March 31st, 2023. 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, 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 31st, 2024 and March 31st, 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 2020.

For 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 one-time benefit payments and contract termination costs. The Company's as has recognized most of its planned restructuring costs in the first quarter. Other income was $4.1 million in interest expense was $1.3 million for the quarter ended March 31st, 2024 compared to other expense of 290,000 and no interest expense for the prior year period. The changes for both other income and interest expense related to our model plant 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 31st, 2024, and 3.8 million for the prior year period. Increases due to higher yields in our investments as a result of increased interest rates, R&D recorded a net loss of $10.7 million or $0.07 net loss per common share for the quarter ended March 31st, 2024, as compared to a net loss of $26.2 million or $0.18 net loss per common share for the quarter ended March 31st, 2023. As of March 31st, 2020 for Aurinia had cash, cash equivalents and restricted cash and investments of $320.1 million compared to $350.7 million at December 31st, 2023. The decrease is primarily related to continued investment in commercialization activities and post-approval commitments of our approved drug look kinase model, plant payments share repurchases and restructuring related payments, partially offset by an increase in cash receipts from sales of the tightness. The Company remains debt-free at March 31st, 2024. With that I would like to hand the call back over to Peter for some closing remarks.

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, thank you.

(Operator Instructions) Maury Raycroft, Jefferies.

Hey, good morning. Thank you for taking my questions. Firstly, on for Maury, just wanted to ask on the implications of the updated label your conversion rate for the PFS has been in the mid 80s. Do you expect that to further push or should we expect primary influence prescribers perception?

So thank you for the question on less. And I think the label update is a recognition of a body by the agency of the data that we provided in addition to the original or pivotal study. And I think it's going to be helpful to us to not be our conclusion concluded in the indication language that on anything beyond one year has not been studied to have that taken out of the three year data incorporated into the label is going to help us, I think, on multiple fronts on a 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 UR. and D. GO guidelines outlined three to five years of therapy approximately. So we see it more as persistency and length of therapy and additive to the the already published data that's out there.

Okay.

Makes sense. And then last month, we had like 156 that accounted the total PSS and Riester. So this is trending a bit lower than the average one month in. Is that just lumpiness or lead to any factors driving the slowness in ITO?

Well, the exact number I think in combination on the PSS plus the restarts and hospitals was closer to one 70 on. So probably just now you're doing the math, I think it was 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.

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

Okay.

Thank you so much.

Stacy Ku from TV Cowen.

Neither I'm 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 is a follow-up to what I believe was the first question. Just can you talk about a big picture? What's your evolving thoughts around patient start forms and the current cancer physicians as we look forward? And then how important is formulary purchases in the hospital channel for your long-term growth?

That's the first question that I have a few follow-ups.

Thank you.

I think it's a great question on. Obviously, PSS, we see as important, but I think as you've seen on because I think it's the best indicator of new patient volume. And since 85% of those convert new patient starts on and kind of our equivalent of an NRX, right, but on this emergence over the last, let's call it, six to 12 months of the importance of restarts and albeit smaller, but emerging hospital business showed new lines of growth. So the way we talk about it, Stacy, internally is more, you know, how what how does our new patient on therapy numbers look within the quarter. And I think that that's that's an important one.

And that's that's a combination of all the trades.

I'm not trying in any way discount the importance of PSF.s. We think all our marketing and selling initiatives that we have out there, the primary drivers identifying new patients and getting new patients on drug on. But for the last, let's call it, zero six, six months plus and a lot of our growth has come from both these restarts, which I think points to the importance of the AURORA two extension study on this label change and the work we've been doing over the last 12 months, but it doesn't, in any way on my mind of discount the need to focus on new patient growth. And while the hospital patients are indeed new patients on the PSS, you're still a major indicator for that.

Okay. Understood. And then around your 24 revenue guidance, you want to just walk through remind us about the seasonality, quarterly cadence expectations and how you feel about kind of your revenue guidance for the high and low end this year?

Well, I as you know, we don't give any on numeric or sort of pillars to the high and the low. But but sort of qualitatively speaking on, I think the low end of the guidance with the with the quarter, we just produced on would have to see on a significant decline or some challenge in summertime and then back to growth in the fourth quarter and the high end of the range 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 had a little bit of a dip during the during the summertime or flattening in the summertime. If we can power through that, we think we have the ability to be in the upper upper end of that range.

And lastly, I think 2Q performance will be a key driver to look at guidance in general and see where we are for the year and with that outperforms on 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 two 20 range is going to be the summer months of the year.

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 hoping to help us understand what does that mean? Can you go into a little bit more detail for us? Thank you so much.

Yes, I think the short answer is on the difference between AUR. 203 hundred in our pipeline was we own on a UR. 200?

Yes, we have follow-on commitments to those that we purchased it from very minimal. But we have we do have commitments and so we will either seek to develop the drug to someone else or to efficiently move the drug forward on our own. If in fact, conversations 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 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 the April BABs space as it pertains to and again in particular. But we think more broadly, there's going to be as a place for our for April bath inhibitors and the B-cell pathway on and much more on, you know, immunology disorders moving forward. So we want to keep this thing moving forward, whether it's in our own hands or someone else's.

Okay.

Understood. Thank you so much.

Thanks, J.C.

(Operator Instructions) Joseph Schwartz, Leerink Partners.

I thank you and congrats on a strong quarter. I wanted to ask first about your initiatives around screening and diagnosis, where is the community now on that front, how much screening is being done and how much have you been able to move that needle? And how is progress there contributing to new patient starts relative to the other initiatives you have ongoing?

Thanks for the question, Joe. I think we have one series of on sort of physician reported IAU. that's been done on 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 pull through yet to actual claims data. And there's no direct on not one to one. And it's kind of even our interpretation of claims data is kind of you have to take some liberties around what's submitted through the claim to trying 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 on patient record audit that was done by us via Optum a few years back looking at lupus patients, couple of couple of hundred thousand lupus patients over several years, and you're looking at numbers like less than 50% of these patients even get a urine screen. This is lupus patients guideline say they should get it every time they come in the office and when they do have a positive proteinuria or proteinuria level that the guidelines would indicate on indeed our lupus nephritis diagnosis, only 30% of a moving get treated and you'd say, Well, geez, why on I think one is just general awareness. And I think you know metrology as Filtrete home proteinuria and lupus nephritis differently. I think they see on protein in lupus nephritis as several grams of proteinuria and or protein in the urine. And they see low proteinuria as not, indeed being on nephritis. Now, that's a little bit of a Liberty from some of the research work we've done. But on the awareness, we need to build is that even low levels are indicative of for outcomes for the patient moving forward. And you're never going to find it unless you're doing a urine screens. And I think we're making impact there more to come as we continue the campaign forward.

Yes, it seems like a great area for white, your white space. I was wondering also regarding the updated label I think that happened a fair amount ahead of expectations, given we are 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 rents in the future with any additional label updates going forward on?

Well, we don't have a REMS in a technical sense. So maybe but I'll answer the question maybe as you're thinking about it, Joe, come back to me with what you mean by by by the brands on that. As we previously communicated communicated, we let the agency know that we were going to do the actions in the extension study and that we were also going to do a biopsy substudy as part of the pivotal on the agency side.

Great. Would love to see that data, but it wasn't packaged as your classic supplemental on NDA rights on so when we are fed this data to the U.S. FDA, obviously we were glad they would take it but understood that it wasn't who could potentially fall outside of the tech the class, the technical technical on a supplemental new drug application process on the agency, luckily treated it much like a supplemental. And I know that they performed within that nine to 12 months category of what a normal supplemental is an arm. We were more conservative probably in our estimate because it technically was, in our view a supplemental NDA package on so it came earlier than than maybe the way we guided externally, which is a positive. And I think in terms of our expectations, this hit pretty much on 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 on. I will say that the on the biopsy substudy data was not incorporated, but we don't think that's limiting on. We think that data can still be made available through publication and through medical drug and information request forms that makes sense.

That answers my question. And then what about on your your recently announced buyback? Have you made any progress on buying any shares back yet?

Short answer is yes, on well within the quarter, but we actually up until the I believe this is up until the end of April, we purchased about 18.4 million worth of stock with an average cost of $5.37, which equates to about $3.4 million of total shares come on just for future because I'm sure that's kind of a follow-on question. We would look to fund any future purchases through our discretionary purchase repurchases through cash flows and not through on what's the cash on hand. And it's at the Board's discretion on. So we'll report out more on buys as we go here, but 18.4 through the end April.

Helpful. Thank you, Aisha.

Ed Arce, H.C. Wainwright.

Hi, good morning. Thanks for taking my questions on just a couple here. I wanted to follow up again really on the bigger picture here, in particular with the updated label. I gather you got me and 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 science campaign and particular targets the rheumatologists and which have been the lower prescribing group of the two just brought a trough on the longer-term perspective and impacts of those well on I'm sure wasn't missed on 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 on within the biologics category when we launched anti-TNF. Remember those numbers on staying 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% and at 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 I see and I can be used on this. Next-generation C&I 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 earlier treatment on it. 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 that people start to actually put these guidelines into place.

So for the longer term, the bigger picture question, we need to see more aggressive diagnosis in the rheumatologist office, we need to see target levels of proteinuria treated by rheumatologists when there are signs, and this is not just a ready is goal. This is the goal of the treatment guidelines and then dose treatment guidelines estimate the patient should be on an estimated three to five years. So all of those things had significant level of improvement that can that can happen. And I think that's what's going to move this this whole category on 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 on, that's kind of the big picture view, at least as we see it at.

Great.

That's helpful for a couple of more, if I may. Just one question on AUR. 200. You mentioned that remains a very interesting target. The April past inhibitor. I'm just wondering if you have any of particular development time lines or anything you can share in terms of our news flow near term with that? And then last question, I wanted to ask about the the comment about that. The newer higher expectations for the kinase pricing 70 to 75 versus the 65 previously off of what is it that you think has persisted and changed your view from from prior expectation?

Thanks again.

Yes, I'll take the first one and then I'll have Joe kind of give his $0.02 on 70 to 75 on average net.

Listen, I guess just to give the most update, our information that we have on an AUR. 200 DIND. was approved by the U.S. FDA on. So we are ready to start on the SAD MAD studies. And we'll as I said on the call, our goal is to keep this thing moving forward. So not when we actually do have a path, whether it's internally or externally forward on, we understand that getting clear about how long those SAD/MAD studies will take when you're going to have your first in human clinical studies and when you should expect to see Phase two data Phase three data, et cetera. And in what indications arm soon. So on, I would earmark that one for a future call, but know that the IND has been approved by the U.S. FDA and we are moving into animal tox and in SAD MAD studies on this year, either through or linear or through an external party on?

So the pricing question, let me let me kick that to Joe and Yes.

To follow up on your pricing question, I think it's kind of two factors. One is obviously pure 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 23, it was about 51% by 12 months. It's now moved to 56% 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 some small price increases over time that have high kind of inched up that number on average.

David Martin, Bloom Burton.

Yes, good morning. Thanks for taking my questions. On first off, I also going back to the updated Leukine 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?

Well, as we've mentioned previously, David, we have patents on file with the U.S. FDA that have not been or the US Patent and Trade Office and have not publicly been disclosed and won't be until we actually get some action, whether it's an acceptance on the patents or not on. I can tell you that regardless of the US label change in the US label can be helpful to those patents in terms of Orange Book listing, and we started looking at that back when we unearth the data from the extension study in general. And I would just leave you with know that, Tom, it follows sort of that line of from a 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 USPTO yet.

Got it. On the second question with restarts becoming more important and trending up? And do you have a read on what percent of patients have the proteinuria rebound after coming off Leukine US and how long does it typically take so that rebound to occur?

The short answer is on and I would look to Greg if he's got a clinical answer to this on. 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 on a new kinase issue. This is an MMF issue. This is a kinase issue. It's any drug that comes after us until we get more alignment to treatment guidelines on 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 of them that they used to treat the disease. So trying to intermittently treat on was a pattern that was just derived from trying to manage these these these potentially toxic drugs that were being put on the patients. But the short answer is we see on this is continuing to be an opportunity as we shift the market more aligned to guidelines.

Greg, what would you what would you add,

but on excuse me, at the end of our program. We monitored patients for a subsequent four weeks and there was on 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 on different individuals will have recurrence of different points.

I'll just emphasize one thing on 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 responses.

Important.

Thank you.

We reached the end of our question-and-answer session. I'd like to turn the floor back over to management for any further or closing comments.

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

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.