Q3 2020 FibroGen Inc Earnings Call

[music].

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the FibroGen 3rd Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's remarks, there will be a question and answer session. To ask a question during that time, you will need to press star 1 on your telephone's keypad.

Ladies and gentlemen, thank you for standing by and walk into the fibro chance a quite a 2020 financial results conference call. At this time all participants are in the listen only mode at the speaker's remarks, there will be a question and answer session to ask a question during that time, you will need to press.

One on your telephone keypad.

Operator: Please be advised that today's conference call is being recorded. If you require any further assistance during the call, please press star zero. I would now like to hand the conference over to your first speaker, Mr. Michael Tung. Thank you.

Please be advised the today's conference call is being recorded.

Michael Tung: Thank you, Robert. And good afternoon, everyone. I'm Michael Tong, Vice President of Corporate Strategy and Investor Relations at FibroGen. Joining me on today's call are Enrique Conterno, our Chief Executive Officer, Dr. Percy Carter, our Chief Scientific Officer, Pat Cotroneo, our Chief Financial Officer, Thane Wettig, our Chief Commercial Officer, Dr. Peony Yu, our Chief Medical Officer, Chris Chung, our Senior Vice President of China Operations, and Dr The format for today's call includes prepared remarks from Enrique and Pat, after which we will open up the call for Q&A.

Michael Tung: I would like to remind you that remarks made on today's call include forward-looking statements about FibroGen. Such statements may include, but are not limited to, our collaborations with AstraZeneca and Astellas, financial guidance... Initiation, Enrollment, Design, Conduct, and Results of Clinical Trials. Our regulatory strategies and potential regulatory results are research and development activities, commercial results, and results of operations, risks related to our business, and certain other business matters. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement.

The business matters.

Each forward looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement a more complete description of these and other material risks can be found in provisions filings with the SEC, including our most recent form 10-K and form 10-Q.

By region does not undertake any obligation to update publicly any forward looking statements.

Whether as a result of new information future events or otherwise.

Michael Tung: A more complete description of these and other material risks can be found in FibroGen's filings with the SEC, including our most recent Form 10-K and Form 10-Q. FibroGen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. The press release reporting our financial results and business update and a webcast of today's conference call can be found in the investor section of FibroGen's website at www.fibrogen.com. And with that, I would like to turn the call over to Enrique Conterno, our CEO. Enrique?

Plus or a treatment for patients with anemia of <unk>.

Together with our partners, we had 42% ations, including 10 oral.

Which add to the understanding of rocks adduced us efficacy and safety profile.

And the unmet need and then met medical need in anemia of C. A D.

The rocks are those the clinical data demonstrated consistent efficacy and reassuring safe to results.

Cross the continuum of C K the patients with anemia.

Adding to the established body of evidence highlighting rocks are those that as a potential foundational treatment for this condition affecting millions of patients.

Enrique A. Conterno: Very good. Thank you, Mike. And good afternoon, everyone.

Enrique A. Conterno: And welcome to our third quarter 2020 earnings call. We're making strong progress on our commitment to bring our potential first-in-class medicines to patients suffering from chronic and life-threatening conditions. Despite the challenges presented by the COVID-19 pandemic, I will begin today's call by providing a high-level summary of the most important accomplishments and developments from the last few months. Pat Cotroneo, our CFO, will then review the financials, after which we will open up the call to your questions.

Enrique A. Conterno: Today's call will include a high-level review of the RoxaDusta data from the recent American Society of Nephrology conference, continued strong Chinese results, and updates on Roxadustat and our clinical trial program. So let us get started with the recent ASN meeting. This year at ASN Kidney Week, alongside our partners, AstraZeneca and Astellas, we presented new analysis on Roxodustat, our investigation of first-in-class oral treatment for patients with anemia of CKD. Together with our partners, we had 42 presentations, including Tan Oro, which add to the understanding of Roxadusta's efficacy and safety profile and the unmet medical need for anemia of sickle The RoxaDusta clinical data demonstrated consistent efficacy and reassuring safety results across the continuum of CKD patients with anemia, adding to the established body of evidence highlighting roxadustat as a potential foundational treatment for this condition affecting millions of patients. We also presented data on the significant burden of anemia in CKD.

At lower rates of Mace unmet plus the patients who achieved hemoglobin rates below 10.

Enrique A. Conterno: A reminder that new treatment options for these patients are sorely needed, especially on the efficacy front. A major goal in treating anemia is to reduce the risk of red blood cell transfusion, a significant risk for CKD patients, and Roxa D'Usta demonstrated a statistically significant improvement in these important clinical measures. The efficacy results were consistent across a wide range of patient populations, including non-dialysis dependent, insulin dialysis, dialysis-dependent, and Peritoneal Dallas, and included analysis in patients with diabetes, Roxodusta demonstrated the ability to consistently maintain hemoglobin levels above 10 in the vast majority of patients, and data from a trial suggest that the risk of transfusion increased four to five-fold in patients with hemoglobin levels less than 10, versus those with hemoglobin levels greater than 10, regardless of treatment. Moving to safety, two late-breaking abstracts explored cardiovascular outcomes of patients with anemia of CKD treated with roxodustat, including the associations In this post hoc analysis, patients who achieved hemoglobin levels above 10 had lower rates of MACE and MACE+ than patients who achieved hemoglobin rates below 10.

At the end of the second quarter.

We continue to see significant roxadustat utilization across the range of different patient populations with anemia in CKD.

About two thirds of patients on Roxadustat.

Our on dialysis.

Split between Temodar say, some peritoneal dialysis.

The 21.

And should that occur the official launch within the Dallas, Oregon.

The stations would come at.

Enrique A. Conterno: A neural presentation of an exploratory analysis showed a lower rate of hospitalization for heart failure in dialysis-dependent CKD patients treated with Roxatustat when compared with EPOT in ALS. Finally, multiple presentations reinforce Roxadustat's safety profile related to neoplasms, hypertension, and ophthalmological effects. In summary, Rochda Dustad was a highlight of the ASN conference, with 20 of the Top 10 Viewed Posters, including the top two. We appreciated a widespread interest in the potential for oxodusta to transform the treatment of patients with anemia of sickness. Moving now to China.

Assuming approval real cause I do still would be available in the first quarter of 2021, and we plan to officially launching a non Dallas independent sitting in the second quarter of 2021.

This is how awareness activities and discussion with payers are well under way.

We have submitted manuscripts covering the phase III data for publication.

Both for the individual trials and pose datasets and.

And expect to have them on the time of lunch.

Finally, we continue to work with large dynasties providers on our too I'm going to phase three b rocks or do stuff clinical trials in the U S Dallas setting.

Enrique A. Conterno: In China, we're pleased to report net sales of Roxadusta of $22.7 million dollars for the third quarter versus $15.7 in the second quarter. We're seeing an increase in uptake. She's been driven by both an expansion in hospital listings and broad adoption with enlisted hospitals. Hospital listings continue to be a key focus of our launch effort. Notably, as of the end of the third quarter, Roxadusta was listed in hospitals representing approximately 55% of the CKD anemia market opportunity in China. This is in comparison to the 45 reported at the end of the second quarter.

Enrique A. Conterno: We continue to see significant Roxodusta utilization across the range of different patient populations with anemia of CKD. About two-thirds of patients on ruxodustat are on dialysis, split between hemodialysis and peritoneal dialysis. And within hemodialysis, initial adoption has been in patients who do not respond well to ESAS, as well as in Instant Dialysis Patients. The broad utilization pattern bodes well for long-term success and provides important learnings as we prepare to launch Roxadusta in the U.S. and other countries. We look forward to keeping you updated as we advance. Our long-term goal is to make Roxodusta the standard of care in treating China's TKD anemia patients.

Which we passed enrollment.

The vulnerability of these patients with severely compromised lung function.

Unfortunately, the current coffee situation continues to be extremely challenger for enrollment and has also delayed the initiation of surface too.

Ah such will it be providing guidance for upon railroad map.

In L. A P C and D M D.

But not an IP effort this time.

Enrique A. Conterno: Let us turn now to the U.S. Regulatory Review and Commercial Preparation for Roxadustin. We continue to be pleased with the pace of and engagement with the FDA. And, as we have discussed previously... We will not be making comments on the ongoing interactions with the FDA.

Enrique A. Conterno: We and AstraZeneca are working closely on U.S. launch preparation activities. Assuming a positive decision by the PDUFA date of December 20th, the plan is to immediately apply for the Transitional Drug Add-on Payment Adjustment, or TADAPA, which would provide Burkman-Fordox-Dustat for dialysis-dependent patients. Outside of the Prospective Payment System Bundle, Roxa Dusta could receive Tadapa coverage would be April 1st. Once that occurred, the official launch within the Dallas organizations would come in.

Enrique A. Conterno: Assuming approval, RocaDusta will be available in the first quarter of 2021, and we plan to officially launch it in a non-dialysis-dependent setting in the second quarter of 2021. Disease awareness activities and discussions with payers are well underway. We have submitted manuscripts covering the Phase III data for publication, both for the individual trials and pooled datasets, and expect to have them at the time of. Finally, we continue to work with large dialysis providers on our two ongoing Phase 3b Roxas-Doostad clinical trials in the U.S. dialysis setting. The filing for Roxodusta for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis, is under review by the European Medicines Agency. In Japan, the SNDA filing, for the indication of anemia of CKD in non-dialysis-dependent patients, is under review, and we continue to expect a decision by year.

345 or 10.

Enrique A. Conterno: Moving now to our pipeline, I would like to provide timeline guidance for our clinical trial. Please note that the COVID-19 pandemic continues to present challenges to the conduct of clinical trials across our industry. We continue to monitor the situation and will take action as necessary, starting with Roxa Dusta for our Phase 3 trial in Melodysplastic Syndrome, or MDS.

It's fully operational Fibrogen is expected to recognize revenue based on net sales to the distribution entity.

Enrique A. Conterno: Expect top-line data in the first half of 2022 for our Phase 2 trial in chemotherapy-induced anemia or CIA patients. We expect top-line data in the second half of 2021, and if successful, plan to quickly initiate a phase three program. Moving now to Pembrelo, Mexico.

Enrique A. Conterno: As we have mentioned over the prior month... The most affected of our trial continues to be the Pamprelo-Mass-Zephyrus IPF trial, in which we post enrollment due to the vulnerability of this patient, severely compromised lung function. Unfortunately, the current COVID situation continues to be extremely challenging for enrollment and has also delayed the initiation of Cephrus II. We will be providing guidance for Pambrello Map in LAPC and DMD, but not in IPF. Given the different COVID scenarios, there is variability in our projected IPF enrollment timelines, and we will continue to evaluate and plan to update you at the appropriate time. In August, we initiated Lelanthus, a phase 3 trial of pambrelumab in approximately 90 patients with non-ambulatory Duchenne muscular dystrophy, or DMD.

And first commercial sale in the U S.

At this point in time, we have no changes and expectations and any of the anticipated milestones between now and mid 2021.

Based on our latest forecast theater, we now estimate are twenty-twenty ending cash cash equivalents restrict the time deposits.

Enrique A. Conterno: And we expect top-line data in the second half of 2022. We also plan to initiate a second phase 3 trial, Lelantus 2, in approximately 70 patients with ambulatory DMD. Finally, for LAPIS, our Phase 3 trial in locally advanced and resectable pancreatic cancer, we expect top-line resection data in the second half of 2022. We remain focused on accelerating enrollment in all of our ongoing clinical trials while ensuring patient safety. Lastly... I want to welcome Kurt Kristofer, who has just joined FibroGen as Chief Business Officer, with responsibility for business development, alliance management, and reporting. I will now turn the call over to Pat Cotroneo, our CFO, to review the financials. Pat?

I'm looking forward to the rock seduced a regulatory decision in the U S by year end.

Robert If you could now open the lines for questions.

Thank you and at this time I would like to remind everyone in order to ask a question simply press fire followed by the number one on your telephone keypad and if you wish to withdraw your question. Please press the pound key.

We'll have her first question coming from the line if my <unk> with Jefferys. Your line is open.

[noise] [noise], hey, guys, thanks, and congrats on the progress, particularly in China I had a two part question one was regarding the big picture implications of.

Whether a drug has a black box or not and Oh Wow astrazeneca at some very nice comments. This morning, I guess for investors is there an implication to the opportunity or could they use you know I'm sure you've thought about this whether a drug has a black box or not sure maybe just run through what those things might mean.

Pat Cotroneo: Thank you, Enrique. As announced today, total revenue for the third quarter of 2020 was $44 million, as compared to $33.2 million for the third quarter of 2019. The current quarter's revenue consists of net product revenues of $22.7 million for Roxadustat sales in China. $20.7 million in development revenue. $2.3 million for sales of bulk drug product to AstraZeneca and a net reduction of $1.7 million for certain adjustments. For the same period, operating costs and expenses were $11.7 million, and net income was $33 million, or $0.36 per basic and $0.35 per diluted share, as compared to operating costs and expenses of $86 million and a net loss of $49.4 million, or $0.57 per basic and diluted share, for the third quarter last year.

And then the second question relates to the <unk> presentation, which you nicely summarized and I guess the idea about having less cardiovascular venturous hemoglobin go shop <unk>.

Very good, but that's sort of course, how amgen maybe it got in trouble later on.

What is the implication of that towards thinking about cardiovascular safety and don't you need to show the control arms as well. Thank you.

Very good thank you Michael and let me try to address the first question is well.

We'll try to answer the second question here with the opinion as well.

In terms of the books warning there are a number of.

Scenarios and let me just remind everyone that we are not planning to comment.

Pat Cotroneo: As mentioned in our last quarterly call, we recently amended our China collaboration with AstraZeneca. The new agreement more optimally aligns both FibroGen and AstraZeneca to maximize the economic value of the Roxidustat franchise and will result in improved and more predictable economics and profitability for fibrogen. Under this amendment, in September 2020, FibroGen Beijing and AstraZeneca completed the establishment of a joint distribution entity that will perform Roxodustat distribution, as well as conduct sales and marketing through AstraZeneca. We amended the collaboration in a number of ways, including establishing a cap on sales and marketing expenses.

Pat Cotroneo: Historically, these co-promotion expenses were billed to FibroGen, and payment was deferred until certain profitability and liquidity provisions were met. At that time of the amendment, we also settled the historical co-promotion costs for both parties to reflect an equal sharing of historical losses and made an adjustment to the co-promotion expense. As a result of these changes, we reversed approximately $84.4 million of co-promotion expenses, which were recorded as a reduction to selling, general, and administrative expenses in the third quarter of 2020. Once the distribution entity is fully operational, FibroGen is expected to recognize revenue based on its sales to the distribution entity.

Hi, Tom when we think about the absolute addressable market died being a a a huge issue, but it was slow down the uptick in the New York there.

In terms of your second question are a saying I think and I think you are referring to the data that we presented on.

I'd shaved hemoglobin levels and corresponding mace outcomes just to recap what the.

Pat Cotroneo: While AstraZeneca is expected to consolidate the distribution entity and recognize revenue on sales to customers, this amendment better aligns the parties' interests and is expected to enable profitability for ROC's do-stack commercialization in China at an earlier point in time. Included in operating costs and expenses for the quarter ended September 30, 2020, was an aggregate non-cash portion totaling $23.6 million, of which $17.9 million was a result of stock-based compensation expense. At September 30th, FibroGen had $719.3 million in cash, cash equivalents, restricted time deposits, investments, and receivables.

What are your interpretation of the of these analyses say.

Is basically that we basically so higher rates.

The hemoglobin levels below eight very high rates of mace.

Red So amazing decrease hemoglobin increase at four four hemoglobin.

Boston, we basically saw the lowest rates of mace and May splice events and these data was quite.

Quite consistent this pattern was quite consistent in both D B and N D B.

We are in 10th of.

Of.

I know I said I think it it's it's important data, but to me I think the number one interpretation of that analysis and let's keep in mind that this is they pose hawk analysis right. So we need to view it the other way.

It's just minding the data that we basically have from a phase three trials. So we should we should do so they are exploring the we we we should be doing my exploratory analysis, but I think the the number one thing is that I need me it needs to be treated.

And we need to treat it seriously because clearly well, we basically sees that for low rates. When hemoglobin is slow we basically sieve high rates of an email by the way this.

Enrique A. Conterno: Looking ahead, we have a total of $245 million in potential milestones expected over the next nine months, for anticipated U.S. and EU approvals and first commercial sale in the U.S. At this point in time, we have no changes in expectations for any of the anticipated milestones between now and mid-2021. Based on our latest forecast data, we now estimate our 2020 ending cash, cash equivalents, restricted time deposits, investments, and receivables to be in the range of $770 to $780 million, assuming U.S. NDA approval in Q4 2020. Thank you, and I would now like to turn the call back over to Enrique. Thank you. In summary, FibroGen is well positioned to continue to make progress in the current environment. Our business continuity plans are in effect, and we're seeing some impact progress in the current environment.

Also below 10, we saw a transfusion rates increase almost Ah four to five fault. So it is basically our own interpretation is basically around the treatment of anemia mm mm mm mm mm the importance of doing so from them.

[noise] medical perspective.

Yeah makes sense. Thank you.

[noise] next question will be coming from the lineup chasing chair Barry West Bank of America. Your line is open.

Hi, This is Patty I'm thinking.

Question.

Can you help explain the market dynamics in China based on data from the answers I think that today the patient numbers more than doubled from 40 to 90000 from kitchen at three too but failed. This health increase did not match that rise in the number of patients.

Explain that.

Yeah, Let me, let me try to provide some color on China, and then I'm Gonna ask Chris shrunk to also help provide some additional commentary.

Clearly we are we're very pleased with with our China with China lunch.

We achieved reimbursement at the beginning of the year and.

As of the end of Q3, we are already listed in 55% of the hospital. This is.

Enrique A. Conterno: Our business continuity plans are in effect, and while we're seeing some impact to our operations resulting from COVID-19, we have the capabilities and resources to navigate through these uncertain times and achieve our stated goals. As Roxasdusta sales ramp up in China, our financial position is strong, with approximately $720 million in cash at the end of the third quarter and a total of $245 million in approval and first commercial sales milestones expected over the next nine months.

Really quite a extraordinary we look at comparable Ah lunches even of products that the public I'm very significant Bronx in China. So very significant listing progress and that is key and I think it's a great signal for long term.

Success.

In addition to that of course, we're seeing the adoption was in those listed hospitals and we just reported basically 22.7.

Million dollars and.

The Q3 versus the 15.7 that we reported and cute too so good consistent progress and when we look at the underlying business fundamentals I consider them to be very very strong.

Operator: We receive full partner reimbursement for all development and commercialization of Roxas Blue Star in all geographies except China, where we share these expenses 50-50 with AstraZeneca. We have an excellent cash position with which to advance our research and development agenda and are looking forward to the Roxadusta regulatory decision in the U.S. by year end. Robert, would you please open the lines for questions?

Right now I think we we view the rocks induced the has the potential to become.

What I would describe as a blockbuster in China, I I I I would find that as a product that has.

Michael Jonathan Yee: Thank you. And at this time, I would like to remind everyone, in order to ask a question, simply press the star followed by the number one on your telephone's keypad. And if you wish to withdraw your question, please press the pound key. We'll have our first question coming from the line of Michael Yee with Jeffries. Your line is open.

Enrique A. Conterno: Hey guys, thanks and congratulations on the progress, particularly in China. I had a two-part question. One was regarding the big picture implications of whether a drug has a black box or not. And while AstraZeneca had some very nice comments this morning, I guess for investors, is there an impact on the opportunity or to the use of the drug, and I'm sure you've thought about this, whether a drug has a black box or not? So maybe I'll just run through what those things might mean.

Patient points more to demand sales in terms of what is actually sold to the page to the to the hospitals and what's actually prescribed so I don't know that we could directly link the two.

Enrique A. Conterno: And then the second question relates to the ASN presentation, which you nicely summarized. And I guess the idea that having less cardiovascular events as hemoglobin goes up seems very good, but that's, of course, how Amgen maybe got in trouble later on. What is the implication of that for thinking about cardiovascular safety? Don't you need to show the control arms as well?

In that linear of a manner as and we keep that there's tremendous uptake, but still with the early launch stage, where there are some new patients new prescribers, who are just getting on drug.

We're trying to track the audio T. as best we can but there's a lot of variability at this time, it's very difficult to link demand to the number of patients, but as you can see from our ex factory sales is a very robust trajectory and we remain very optimistic in terms of what this tells us about the market opportunity.

Enrique A. Conterno: Thank you. Very good. Thank you, Michael.

Enrique A. Conterno: And let me try to address the first question. We'll try to answer the second question here with Peony as well. In terms of the box warning, there are a number of... scenarios. And let me just remind everyone that we are not planning to comment on or speculate on what our interactions with the FDA are right now. But there are a number of; you can speculate about a number of potential scenarios if you wish.

Okay. That's helpful. Thank you.

The next question will be coming from the line of Annabel Samimy with Stifel. Your line is open.

Hi, Hi, Thanks for taking my question. So I had a question about.

What you're less velocity vectra trajectory I know that in the back.

Pluses population, we expect ramp relatively quickly.

Can you talk a little bit about how you expect or at how astrazenecas. That's the bigger non dialysis population just beyond.

Some of the reimbursement challenges or hurdles, where do you expect the primary adoption hurdles to be.

Enrique A. Conterno: So, on the one hand, you can take basically no box warning across any of the indications. Maybe on the other end, you can say, well, we have a box warning that reads like the box warning that ESAs have. Clearly, somewhere in between may be a box warning that maybe reads a little bit differently than what the ISIS box warning is. As we think through this, clearly, first when we look at the dialysis setting, it is pretty clear that today, I think the products that are being utilized for treatment, and patients are treated for anemia in the dialysis setting, in the vast majority, we have those products with a box warning. So in this particular setting, having a box warning is not a disadvantage for users.

Given the wealth of data that you have it seems like physicians can understand the benefit rather quickly notwithstanding a blockbuster and the blackbox order some of the considerations you're thinking about in the MDT operation.

Yes clearly.

The two settings are different.

They also respond to different reimbursement mechanisms.

Mechanisms.

First thing I think for launch anywhere we need to ensure that the roxadustat is going to be reimbursed.

Reimbursed so we need to work towards reimbursement in both Dallas is saying I've commented that's part of why my initial comments on our plan to submit for the DARPA unexpected. The earliest data we feel good reimbursement will be April 1st the 2021.

In the case of Andy the we are also in discussion with payers.

On in this particular case the thing we need to be placed team formularies.

In the different formulary so those.

Enrique A. Conterno: So clearly, not having a box warning is even better, but I view that as something very manageable given the current... When it comes to NDD, in this particular setting, we have most of the patients being untreated. So it's an opportunity to basically build a market and make the case for Roxadustat as a compelling value proposition to be able to treat these patients. But it's a different situation because we are trying to increase treatment rates and ensure that instead of having one out of every ten patients being treated in the setting, we can really move the needle. Clearly, in that setting, a box warning actually would... [inaudible] I don't see, longer term, when we think about the absolute addressable market, that being a huge issue, but it will slow down the uptick in the near future.

Our ventures, and we need to be made that we want to make sure that we're supporting aastra Seneca to be able to.

This arrangements as quickly as possible.

Enrique A. Conterno: In terms of your second question or ASN, I think, and I think you are referring to the data that we presented on achieved hemoglobin levels and corresponding MACE outcomes. Just to recap, what our interpretation of this analysis says is basically that we basically saw higher rates. Uh..., at hemoglobin levels below 8, very high rates of maize.

Enrique A. Conterno: [inaudible] We are intent on... of... That analysis, I think it's.., important data. But to me, I think the number one interpretation of that analysis, and let's keep in mind that this is a post hoc analysis, right? So we need to view it that way.

From Russia does that but in addition to that we need to be thinking about patient activation, ensuring that patients understand that there is a a new treatment option that he said.

Enrique A. Conterno: It's just mining the data that we basically have from phase three trials, which we should do. So they are exploring; we should view them as exploratory analysis. But I think the number one takeaway is that anemia needs to be treated, and we need to treat it seriously because clearly, what we basically see is that for low rates, when hemoglobin is low, we basically see high rates of anemia. And by the way, this also below 10, we saw transfusion rates increase almost four to fivefold. So it is basically, our own interpretation is basically around the treatment of anemia and the importance of doing so from a medical perspective. Yeah, that makes sense.

So we we have a great partner and Astrazeneca and we look forward to supporting them in ensuring that.

And then we can be as successful as we can be sending I'm gonna ask saying if he has any additional comments yeah. Thanks, and we can just a couple of additional comments when we think about the N D. D market, we don't think about it as a market Bill we think about it as a market rebuild just because of the the number of patients who previously had.

Been treated with an Esa that are now not being treated yeah, you've heard the statistics, where no about one in seven patients in the 12 months prior to dialysis are treated with an Esa at one point in time. It was about one in three and so our first goal will be to ensure that we can rebuild that market on the way to them is enrique talked about scaling the the.

Jason Matthew Gerberry: Thank you. The next question will be coming from the line of Jason Gerberry, West Bank of America. Your line is open. Hi, this is Sarian for Jason.

The opportunity in a in a much different kind of scenario as well.

The second thing is.

And the advantage of working with a partner like AC is is.

The significant presence that they have from a patient support and affordability program perspective with their internal easy 360 hub.

Enrique A. Conterno: Thanks for taking our questions. Can you help explain the market dynamics in China? Based on data from AstraZeneca today, the patient numbers more than doubled from 40 to 90,000, from 2Q to 3Q, but the sales increase did not match that rise in the number of patients. Can you help explain that? Yeah, let me try to provide some color on China.

Which we believe will be an important mechanism to ensure eligible patients have the patient support and reimbursement mechanisms in place to assist them in getting and staying on therapy.

Oh, great and if I could just.

One more question you have quite a bit of task. The other thing that's all I'm Gonna get better you don't have a tremendous amount of expense at the last set of any thought beyond chest financing. Your argued program with any additional thoughts two business development and things can you can tell that.

Enrique A. Conterno: And then I'm going to ask Christian to also help provide some additional commentary. Clearly, we are very pleased with our China launch. We achieved reimbursement at the beginning of the year and... As of the end of Q3, we are already listed in 55% of hospitals, which is really quite extraordinary as we look at comparable launches, even of products that have become very significant products in China. So very significant listing progress, and that is key, and I think it's a great signal for long-term success. In addition to that, of course, we're seeing adoption within those listed hospitals, and we just reported basically $22.7 million in Q3 versus the 15.7 that we reported in Q2, so good consistent progress, and when we look at the underlying business fundamentals, I consider them to be very, very strong. Right now, I think we view Roxandusta has the potential to become what I would describe as a blockbuster in China.

Yeah. So so we're not going to be coming in on a business development, but yeah, that's something that as I mentioned.

The previous earnings cause that after this initial face the the first nine months or so which by the way I'd be now I think on my job now 10 months.

The there will be I think an opportunity for us to start thinking about that I'd be able to think about business development and in particular, bringing states are signs that we believe can create significant value for patients and shareholders.

Great. Thank you.

[noise] next question will be coming from the lineup Jeffrey porn shape with S. B B Allobrain Carolina's open.

Thank you very much on.

A couple of quick questions.

I I apologize if you've answered this but what is the latest thinking all the time for the palm level pancreatic cancer study right out.

Secondly, could you just confirm Enrique what you said about the launch timing for anti gay and gay. They specifically next year, assuming success that the F. D. I and then lastly, if the data about LDL reduction meaningful care physicians and potentially helpful to launch or is that something that.

What would be something that you'll be featuring.

Very good thank you Jeff.

Just the let me first address your question about L. A P C. When do we expect a readout.

No we mentioned that we expect topline resection data in the second half of 2022.

Enrique A. Conterno: I would define that as a product that has revenue north of half a billion dollars, so 500 million dollars. So, a very significant opportunity, and we're launching well to be able to try to aim towards that. Clearly, we also see our... [inaudible] As it relates to your question, my understanding, and I'll ask Chris to confirm, but the number of patients that were reported by AstraZeneca were cumulative patients, as opposed to patients in the quarter. And as you know, the duration of treatment, there are some patients that start treatment, some patients that stop treatment, so I don't think that we will be able to just do a calculation that we increase the number of patients, and we're going to double the demand. But we're very pleased in terms of where we are and the opportunity to have Roxadustat start benefiting so many patients in China. And Chris, maybe.

When it comes to.

Your second question was about or last question was about L. D L and impact of L. D L.

We think that is a nice marker to have but at the N. L. D. S. So it's mainly utilize us a marker or for cardiovascular risk and to that extent, we have cardiovascular outcomes that you know certain way our comprehensive to do the entire products. So Ah yes, it's good to have the L. D.

All data that we have showing the Christmas and L. D L. But I think we even more importantly is basically to be able to showcase our overall cardiovascular safety data. Okay. And then just the timing specifically for the two indications.

Relations.

Yes, and in terms of launch for for the two.

For both D D. A N D D well, we are to determine the official launch right because clearly we expect to make the product available as soon as we can after approval, but we expect that the earliest that we would get that that Ah Ah approval would be.

April 1st of 2021, so that's basically what we're targeting the official launch Ah Ah given that's really what would be the catalyst for the diocese organizations to incorporate their products are using the the broke in the way that we we think they could.

Christine L. Chung: Sure, Enrique, so very quickly to supplement what Enrique said, the sales we report are ex-factory sales. I think patients point more to demand sales in terms of what is actually sold to hospitals and what is actually prescribed. So I don't know that we could directly link the two in that linear of a manner.

When it comes to N D D. We expect that the the official launch would would be and also in the second quarter of 2021.

Christine L. Chung: As Enrique said, there's tremendous uptake, but we're still at the early launch stage where there are some new patients, new prescribers who are just getting on the drug. We're trying to track the DOT as best we can, but there's a lot of variability. At this time, it's very difficult to link demand to the number of patients, but as you can see from our X factory sales, it's a very robust trajectory, and we remain very optimistic in terms of what this tells us about the market opportunity. Okay. That's helpful.

Okay. Thank you very much.

[noise] next question will be coming from the line up the around the Firebird with carven, Yeah Linus open.

Yeah, Hi, good afternoon, so about it cause I'm on a couple of questions. Enrique what one is basically a follow up to what you just saw or we're highlighting with Virginia and Davina.

You know better than me or a big clinics and they have pathways and they typically will run pilot programs before they adopt a new drug I know you you have commenced a couple of studies and you're enrolling those studies in both sides can you give us an update on that and how how long do you think before you. Your data is it is it sort of a pseudo or an official pilot program.

And then secondly unto death, when you look historically some of the drugs, whether you know the the irons and you can argue they're not that innovative or even parts of it and you can argue a sense of power was out but most of us in Dallas I've been pretty slow and the the the profit incentive undercut that but really it's a small and mid cap mid train Dallas.

<unk> provided the typically adopted but not the big ones why would it be different with Roxanne. Thank you.

Yeah.

I'm Gonna ask Biyani to comment on our phase three B studies, which we are conducting.

Would Dallas is organizations, who would you like to make some comments.

Oh I guess.

Yes, we are working with some of the largest dialysis Ah Ah Ah organization and the two studies I going exceptionally well. This is a a and I'm opportunity for the U S dialysis organizations to further study Ah Ah product and.

Annabel Eva Samimy: Thank you. The next question will be coming from the line of Annabel Samy with Stiefel. Your line is open.

Enrique A. Conterno: Hi, Hi. Thanks for taking my question. So I had a question about what you expect from the long trajectory. I know that in the dialysis population, you expect to ramp relatively quickly. Can you talk a little bit about how you expect or how AstraZeneca expects to build a non-dialysis population just beyond some of the reimbursement challenges or hurdles? Where do you expect the primary adoption hurdles to be? Given the wealth of data that you have, it seems like physicians can understand the benefit rather quickly, notwithstanding a black box or a no black box. So what are some of the considerations you're thinking about in the NDD population? Yeah, clearly, the two settings are different, and they also respond to different reimbursement mechanisms.

Huh.

Studies I expect it to be finished I in the first half of 2021, and we'll be I in time to support online <unk>.

In terms of thank you for your only on in terms of that but if I understood. Your question you were looking at other.

Examples I.

I I I I I would share with my view is here, but.

Having reimbursement doesn't mean that you're gonna get to use right. The reason why we believe or I could do something will be utilized isn't because of the overall clinical profile that he'd offers not because he has a favorable sorry to a federal reimbursements came so we.

Think that Russia, just start offers a a number of benefits I think if we think about his trade off the bat and he's in Dallas is the the excellent data that we have with.

Showing basically reduce cardiovascular outcomes in this population Ah so that's.

Extremely important Ah clearly there are a number of patients we estimate maybe about 20 per cent of patients on dialysis.

Enrique A. Conterno: First thing, I think for a launch anywhere, we need to ensure that Roxaduta is going to be reimbursed. So we need to work towards reimbursement in both the dialysis setting. I've commented as part of my initial comments on our plan to submit for TADAPA and expect that the earliest date that we could get reimbursement will be April 1st, 2021.

Not respond well do ethos or are you very very high doses in many cases.

We think those are also I'm pretty sure that would be give me the experience that we have in China and when we see patient that would be candidates for it <unk>.

So to US I think it's G. Overall.

Benefit benefit profiles of the product offers does that in itself I think is important because it allows for the product to be used and to ensure that there's not gonna be a negative.

Enrique A. Conterno: In the case of NDD, we are also in discussions with payers, and in this particular case, I think we need to be placed on formularies. have those arrangements as quickly as possible. So that's an important part of thinking about, you know, just ensuring that there's going to be adequate reimbursement over time. We need to think about, as we think about NDD, that in this particular case, it is not just about treating the current patients that are being treated. So we basically...

Incentive or negative economic driver. So if anything I think it's positive a driver from a reimbursement perspective for the use of the product. So I would look not due to that but but really to the profile of the protocol.

To to see why why why we believe that put it will be utilized.

Thank you.

Next question will be coming from the line S. B C. Yeah with Mizuho. Your line is open.

Hi, Good afternoon, everyone. This is Alex on for a debate. Thank you for taking the questions first one I guess given that you will be potentially first to market in dialysis could you give us a bit of color and how you are engaging with the large dialysis providers in the U S.

And if you would expect to secure contracts with the two large providers following approval what would you expect to secure contracts maybe anymore staggered manner.

Enrique A. Conterno: Educate the overall marketplace on the importance of treating anemia, and that's why I'm insisting on the comments about some of the benefits when it comes to anemia and some of the comments that I made during... The initial comments in this conference call. It is incredibly important that we are up front now. Roxadustat has, as you mentioned, a number of benefits, so we think that it has the right efficacy and safety profile to be able to have a really good uptake in the NDD setting and be able to be a catalyst for the overall expansion of that market.

Or just one of them and then a follow up thank you.

Yeah, clearly we wanted our the utilization of the product to be broad.

We're not gonna be commenting on where are where are we on our discussions.

With a different provider clearly we need to make sure that the product.

Will receive approval, but it is pretty clear that we've been working with them pretty closely for quite some time keep in mind that we conducted on phase three clinical trials with them. We're also conducting this three b phase three b studies with with the.

Enrique A. Conterno: We, over time, are not going to be satisfied with just treating 20% more patients, or we need to be thinking about a scalar in terms of expanding this marketplace, and this is going to happen, of course, over time, and to do that, yes, we will need to make sure that we're reaching the appropriate physicians, not only the physicians that are prescribing and treating anemia today but the ones that we think are seeing those patients that could benefit So we have a great partner in AstraZeneca, and we look forward to supporting them and ensuring that we can be as successful as we can be in that setting. I'm going to ask Thane.

With the dialysis organizations. So I I feel that we are in a really good position and also what is what is the overall profile of once again the.

The medicine that we're offering and we think that he can be a significant value from medical perspective. So ah two patients tend to because her organization. So we we feel good in terms of where we are I think in in our discussions.

Our intent is not too is to try to offer the product.

To be able to reach a as many patient says.

So we can clearly getting tied up.

In fact been effective will be critical towards that goal.

Okay, great. Thank you and then just a quick follow up another question on China I'm wondering if you could provide a bit of color around rocks us uptake, specifically and staples dialysis patients who are already on the essays are you seeing a bit more conversion to Iraq stuff from these patients today.

Thane Wettig: If any additional comments, Yeah, thanks, Enrique. Just a couple of additional comments. You know, when we think about the NDD market, we don't think about it as a build-up; we think about it as a rebuild, just because of the number of patients who previously were treated with an ESA that are now not being treated. You've heard the statistics where about 1 in 7 patients in the 12 months prior to dialysis are treated with an ESA. At one point in time, it was about 1 in 3, and so our first goal will be to ensure that we can rebuild that market on the way to then, as Enrique talked about, scaling the opportunity in a much different kind of scenario as well.

As compared to let's say six months ago.

Yeah, I'm going to ask Chris to maybe provide some comments on that.

So the way, we look at C and maintenance dialysis marketing first of all is those with controlled Ah hemoglobin levels and uncontrolled hemoglobin levels and also paratonia dialysis in hemodialysis. So.

So first of all I would look at the P. D population with done extremely well in the P. D population.

Hi.

Speak smiled to the clinical profile rock cities that the oral administration feature obviously is attitudes and attracted that this population for very obvious reasons, we doing particularly well in in P. D.

Joseph H D. There is a very different value proposition.

For those with uncontrolled hypertension, uncontrolled hemoglobin and controlled for those that are uncontrolled really is the initial adoption population and a target large population. It speaks very well to the differentiation based on iron mobilization and inflammation. So the clinical valley.

Thane Wettig: The second thing is the advantage of working with a partner like AZ is the significant presence that they have from a patient support and affordability program perspective with their internal AZ360 hub, which we believe will be an important mechanism to ensure eligible patients have the patient support and reimbursement mechanisms in place to assist them in getting and staying on therapy. Great. And if I could just,

The proposition there is is very very strong and that's where we see a lot of the early adopters.

Seeing migration into the controlled population and a thesis there is it's important to treat it's important to treat to target. It's important to maintain so that there should be a little low variability, but as a matter of pricing we are higher than Isa so the value proposition and the differentiation day or something.

Different but we're very happy to see migration into that population, which frankly was not the initial focus but with the maturing much we're seeing adoption. So we're delighted to see that.

Enrique A. Conterno: Follow on one more question, you have quite a bit of cash building, that's only going to get better, you don't have a tremendous amount of expense with the launch, so is there any thought beyond just financing your R&D programs, any additional thought to business development and things you need to build out? Yeah, so we're not going to be commenting on business development. But yeah, that's something, as I mentioned on previous earnings calls, that after this initial phase, the first nine months or so, which, by the way, I've been now, I think, on my job now, ten months. There will be, I think, an opportunity for us to start thinking about that and be able to think about business development and, in particular, bringing... Thank you. The next question will be coming from the line of Jeffrey Porges with SVBL Rink. Your line is open.

The last thing that I would say and if you did not as these question, but Ah clearly in in addition, Ah. In addition to looking at the see what Bush's in Dallas is clearly I think what we see is really good adoption within the instant dialysis patients, which at the end I think it's a great predictor.

What the brand could be what what are the run could be in this medicine could be in the future.

Thank you.

We have a final question for me the lineup Ciorbea hiding what city, you're Linus open.

Hi, Thanks for taking the questions S N a T V I presented data for that adduced.

And there are non dialysis patients showing that the U S mail looks quite a bit better than it was the X U S. Mess that was really hurting their main outcome I guess with that in mind could you characterize how you're not I also said it looks in terms of any differences between the the mace and the.

U S patients versus patients enrolled actually us.

Yeah.

Maybe let let me just make some overarching comments because clearly are trouse design, a little bit different from from Vajda in terms of we were going as you know relative to placebo, but importantly, also we treat at 11 plus minus one.

Michael Jonathan Yee: Thank you very much, and I appreciate all the answers. A couple of quick questions. First, and I apologize if you've answered this before, but what is the latest thinking on the time for the PAM-Revlimab pancreatic cancer study readout? And then secondly, could you just confirm, Enrique, what you said about the launch timing for NDD and DD, specifically next year, assuming success at the FDA? And then lastly, is the data about LDL reduction meaningful to physicians and potentially helpful to launch, or is that something that won't be something that you'll be featuring? Very good. Thank you, Jeff.

On whether you're watching the U S and R. O U S. So we didn't we utilize the same treatment targets for rocks or do stuff.

Now when it comes to rock so I think of what's important is when we first one we look at the overall trial, we basically see that and MTV, we were comparable to placebo. So that's when it comes to me. So that's critically important we we.

Showed non inferiority.

The best trial for Us to look at which is not part of our posts studies, but the first the best try that will be more most comparable to Ikea trials will be dolomites, when she said trial, where we compare it against a inactive comparison.

Enrique A. Conterno: Just let me first address your question about LAPC. When do we expect a readout? And we mentioned that we expect top-line resection data in the second half of 2022. When it comes to...

In double button and he was conducted outside of the U S.

So that's you know you're you're getting them both points and the hassle ratio that we so I'm I'm by the way we treat it too once again 11, plus minus one okay.

Enrique A. Conterno: Your second question was about, or the last question was about LDL and the impact of LDL. We think that is a nice marker to have, but in the end, LDL is mainly utilized as a marker for cardiovascular risk. And to that extent, we have cardiovascular outcomes that, in a certain way, are comprehensive for the entire product. So, yes, it's good to have the LDL data that we have showing decreases in LDL, but I think even more importantly is basically to be able to showcase our overall cardiovascular safety data. Okay, and then sorry, just the timing specifically for the two indications of population. Yes, and in terms of launch for the two, for both DD and NDD.

We we saw hustled ration he may soft 0.81.

So oh honestly, we we feel very good about.

About our data and I don't know puny view, when I anything else today.

Yes, Uh huh, Thanks, Enrique Ah, yes, we.

So that you know as in the case that at the tone of my study is not 100% X U S and and and we had a is that we are sharing has that ratio and now I'd.

M B, a placebo control, which is our main program we saw consistency in the U S stayed out with.

That is consistent with the overall amazed program.

Very good so we.

And and that's you'd know that placebo is a high standard fired a measurement all for safety and and and we are glad that we have chosen this standard.

Enrique A. Conterno: Well, we are determining the official launch, right? Because clearly, we expect to make the product available as soon as we can after approval. But we expect that the earliest that we would get DAPA approval would be April 1st, 2021. So that's basically what we're targeting, the official launch, given that's really what would be the catalyst for the dioceses organizations to incorporate their product and use it in the way that we think they could. When it comes to NDD, we expect that the official launch will also be in the second quarter of 2021.

Right.

Yeah for the great contacts or maybe one other questions also on the competitive landscape and I think recently on clinical trials Dot Gov. G. S. K, you know moved sooner the timelines for the Readouts for that produced that it looks like November 2024 dialysis in April of 2021.

For nine dialysis uhm any predictions therefore, how the results could look you know whether they could resemble you. Your your data or are there differences to consider.

I think that's a good question for them.

[laughter].

Sounds good thank you.

Alright, do we don't have any more questions on the line speakers. Please continue.

Enrique A. Conterno: Thank you very much. The next question will be coming from the line of Yaron Werber with Cowen. Your line is open. Yeah, hi, good afternoon.

Very good I.

Once again I appreciate everyone's time today, we report our third quality results. We're very pleased with the progress as I mentioned across number of France and of course, we are looking forward to the action date of December.

Yaron Werber: Seba, if you don't mind, a couple of questions, Enrique. One is basically a follow-up to what you just were highlighting. With Fresenius and DaVita, you know, these are big clinics, and they have pathways, and they typically will run pilot programs before they adopt a new drug. I know you've commenced a couple of studies, and you're enrolling those studies in those sites. Can you give us an update on that, and how long do you think it will take before we get an update on it? Is it sort of a pseudonym or an official pilot program? And then secondly, on Tadapa, when we look historically at some of the drugs, whether, you know, the irons, and you can argue they're not that innovative, or even Parsiviv, and you can argue Sensopar was out, but launches in dialysis have been pretty slow, and the profit incentive under Tadapa, really, it's a small and mid-cap, mid-chain dialysis providers are typically Why would it be different with Roxa?

20th for record the studs, which is a real close up a different date here in the United States. Thank you very much.

And this concludes today's conference call. Thank you everyone for your participation in you may now disconnect have a good day.

[music].

Enrique A. Conterno: Thank you. I'm going to ask Peony to comment on our Phase 3B studies which we are conducting with Diocese organizations. Peony, would you like to make some comments? Yes, thanks, Enrique.

Peony Yu: Yes, we are working with some of the largest dialysis organizations, and the two studies are going exceptionally well. This is an opportunity for U.S. dialysis organizations to further study our product. The studies are expected to be finished in the first half of 2021 and will be in time to support our launch. And in terms of, thank you, Peony, and in terms of Tadapa, if I understand your question correctly, you're looking at other things. Examples.

[music].

Enrique A. Conterno: I... I will share what my view is here, but... Having reimbursement doesn't mean that you're going to get used, right? The reason why we believe Roxoduta will be utilized is because of the overall clinical profile that it offers, not because it has favorable reimbursement. So, we think that Roxadustar offers a number of benefits. I think if we think straight off the bat about insulin dialysis, the excellent data that we have with showing basically reduced cardiovascular outcomes in this population are extremely important.

Enrique A. Conterno: Clearly, there are a number of patients who, we estimate, maybe do not respond well to East, are in very, very high doses. I think those are also...

Enrique A. Conterno: Given the experience that we have in China and what we see, patients that would be candidates... So to us, I think it's the overall picture. Tadapa, in itself, I think is important because it allows for the product to be used and ensures that there's not going to be a negative.

Enrique A. Conterno: Thank you. The next question will be coming from the line of V. Faye Young with Mizuho. Your line is open. Hi, good afternoon, everyone. This is Alex on behalf of DFAY.

V. Faye Young: Thank you for taking the questions. First one, I guess, given that you will be potentially first to market in dialysis, could you give us a bit of color on how you're engaging with the large dialysis providers in the U.S.? And if you would expect to secure contracts with... Two large providers following approval, what would you expect to secure contracts with, maybe in a more staggered manner, or just with one of them?

Enrique A. Conterno: Yeah, clearly, we want our utilization of the product to be broad. We're not going to be commenting on where we are in our discussions with a different provider. Clearly, we need to make sure that the product will receive approval, but it is pretty clear that we've been working with them pretty closely for quite some time. Keep in mind that we conducted our phase 3 clinical trials with them. We're also conducting these phase 3B studies with dialysis organizations. So I feel that we are in a really good position. Also, what is the overall profile of, once again, the...

Enrique A. Conterno: The medicine that we're offering, and we think that it can be of significant value from a medical perspective, so to patients and to health care organizations, so we feel good in terms of where we are. I think in our discussions, our intent is not to try to offer the product, to be able to reach as many patients as possible as we can, and clearly getting to DAPA, being effective will be critical towards that goal. Okay, great. Thank you. And then just a quick follow-up, another question on China.

Enrique A. Conterno: I'm wondering if you could provide a bit of color around Roxa's uptake, specifically in stable dialysis patients who are already on ESAs. Are you seeing a bit more conversion to Roxa from these patients today versus compared to, let's say, six months ago? Yeah, I'm going to ask Chris to maybe provide some comments on that. So, the way we look at the maintenance dialysis market, first of all, is those with controlled hemoglobin levels and uncontrolled hemoglobin levels and also peritoneal dialysis and hemodialysis.

[music].

Christine L. Chung: So, first of all, we'll look at the PD population. We've done extremely well in the PD population. It speaks well to the clinical profile of roxodustat. The oral administration feature is obviously additive and attractive to this population for very obvious reasons. So, we're doing particularly well in PD. In terms of HD, there is a very different value proposition for those with uncontrolled hemoglobin and those who are controlled. For those that are uncontrolled, really, it's the initial adoption population and a target launch population. It speaks very well to the differentiation based on ion mobilization and inflammation. So the clinical value proposition there is very, very strong, and that's where we see a lot of early adoption. We are seeing migration into the controlled population, and the thesis there is that it's important to treat, it's important to treat the target, it's important to maintain so that there's very little low variability, but as a matter of pricing, we are higher than. So the value proposition and the differentiation are a little bit different, but we're very happy to see migration into that population, which frankly was not the initial focus. But with the maturing

Enrique A. Conterno: So we're delighted to see that. The last thing that I would say, and you did not ask this question, but clearly, in addition to looking at stable patients on dialysis, clearly, I think what we see is really good adoption within the instant dialysis space, which, at the end, I think is a great predictor of what the brand could be in, and what this medicine could be in the future. Thank you. We have our final question from the line of Joel Biatti with Citi. Your line is open.

Joel Biatti: ASI and Akiva presented data for Vatadustat in their non-dialysis patients showing that the US mace looked quite a bit better, and it was the ex-US mace that was really hurting their mace outcome. With that in mind, could you characterize how your non-dialysis data looks in terms of any differences between the mace in the US patients versus patients enrolled outside the US? Yeah.

Enrique A. Conterno: Let me just make some overarching comments because clearly, our trial is designed a little bit different from VARA in terms of where we were going, as you know, relative to placebo. But importantly also, we treated 11 plus minus 1, whether it was in the U.S. or O.U.S. We utilized the same treatment targets for roxadustat. Now, when it comes to rocks, I think what's important is that when we first look at the overall trial, we basically see that in NDV, we were comparable to placebo. So that's when it comes to the mace.

Enrique A. Conterno: So that's critically important. We showed that non-inferiority. The best trial for us to look at..., which is not part of our post-study, but the best trial that will be most comparable. Acuvia Trials will be Dolomites, which is a trial where we compared Acuvia with an active comparison in Darbo Potting, and it was conducted outside of the U.S. So that's, you know, you're hitting on both points. And the hazard ratio that we saw, and by the way, we treated it to, once again, 11 plus minus one. We saw a high acceleration in May of 0.1% 8-1. So, honestly, we feel very good about our data. And I don't know, Kyuwon, if you want to add anything.

Enrique A. Conterno: And so, you know, as Enrique said, that the dolomite study is 100% ex-U.S., and we had a very reassuring hazard ratio. In the placebo control, which is our main program, we saw consistency in the U.S. data that is consistent with the overall MACE program. And as you know, placebo is a high standard for a measurement of safety, and we are glad that we have chosen this standard. These are great contacts there. And maybe one other question is also on the competitive landscape, and I think recently on clinicaltrials.gov, GSK moved the timelines for the readouts for debt-produced debt, it looks like November 2020 for dialysis and April 2021 for non-dialysis. Any predictions there for how the results could look, you know, whether they could resemble your data, or there's differences to consider? I think that's a good question for them.

[music].

Joel Biatti: Sounds good. Thank you. All right. We don't have any more questions on the line. Speakers, please continue. Very good. I, uh... Once again, I appreciate everyone's time today as we report our third-quarter results. We're very pleased with the progress, as I mentioned, across a number of fronts. And, of course, we are looking forward to the action date of December 20th for Rexelustad, which is the Rexelustad-PDUFA date here in the United States.

Thank you very much. And this concludes today's conference call. Thank you, everyone, for your participation, and you may now disconnect. Have a good day. ??? ??? ??? ??? ??? ??? ??? ??? , , , , , , , , , , , , , , , , , , , , , ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? This is a production of the Center for Autism and Related Disorders Center for Autism and Related Disorders ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??