FibroGen, Inc

Ladies and gentlemen, thank you for standing by and welcome to the FibreGen fourth quarter and full year 2020 financial results conference call. At this time, all participants are in the listen only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to have a conference over to your speaker today, Mr. Michael Tong. Thank you. Please go ahead.

Thank you, Lyndon. And good afternoon, everyone. I'm Michael Tong, Vice President of Corporate Strategy and Investor Relations at FibreGen. 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, Dr. Mark Eisner, our Chief Medical Officer, Dane Wedig, our Chief Commercial Officer, Chris Chung, our Senior Vice President of China Operations, and Dr. Elias Khashoggi, our Senior Vice President of Clinical Development, Drug Safety, and Pharmacovigilance. The format for today's call includes prepared remarks from Enrique and Pat, after which we will open up the call for Q&A. 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, our 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. A more complete description of these and other material risks can be found in Fibergen's filings with the SEC, including our most recent Form 10-K and Form 10-Q. Fibergen 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 on the investor section of Fibergen's website at www.fibergen.com. With that, I would like to turn the call over to Enrique Quintero, our CEO. Enrique?

Enrique Quintero Very good. Thank you, Mike, and good afternoon, everyone, and welcome to our fourth quarter and full-year 2020 earnings call. I intend to reflect on my first year as CEO of Fibrogen by providing a high-level summary of important accomplishments and developments, not only in recent months, but also for 2020. Pat Cotroneo, our CFO, will then review the financials, after which we will open the call for your questions. I continue to be confident in my assessment that FibroGen has a unique opportunity to create significant value for patients and shareholders by executing on our three areas of focus. Number one, ensuring regulatory and commercial success of Roxadustat, a transformational medicine for the treatment of anemia, first in patients with chronic kidney disease and with significant potential for expansion to additional indications. Number two, accelerating the development of panbrevlimab in three high-value indications, locally advanced and resectable pancreatic cancer, Duchenne muscular dystrophy, and idiopathic pulmonary fibrosis. And number three, strengthening our research capabilities to maximize our scientific and medical leadership position in both HIF and CTGF biology. In addition, we are focused on expanding our clinical development pipeline by evaluating both internal and and external opportunities to address unmet medical needs. Today's call will include a review of Roxadustat, our continued strong performance in China, and our clinical trial programs. Let us get started with the Roxadustat New Drug Application, or NDA, review. Last December, in the final stages of review, the FDA extended the review period of the NDA by three months to review additional analysis of existing clinical data and set a new PDUFA date of March 20, 2021. Just today, we were informed by the FDA that they plan to hold an advisory committee or adcom meeting to review the NDA for Roktadustad in the U.S. We have not received a schedule for the planned adcom. We are surprised by the timing of this request, On three separate occasions, the FDA indicated they were not planning to hold an ADCOM at that time. First, when the NDA filing was accepted, then after the mid-cycle review, and finally after the late-cycle review. It would not be unusual for the FDA to hold an ADCOM for a first-in-class new molecular entity, and as communicated last spring, we were preparing for this possibility. We will now resume those preparation activities and look forward to presenting the comprehensive Roxadustat data. We continue to have confidence in the completeness of our NDA submission and the strength of our data, and Fibrogen and AstraZeneca are committed to working with the FDA to bring Roxadustat to patients with an email CKD in the US. As you can appreciate, and has been the case throughout the final stages of review, we will not be able to discuss the details of our FDA interactions. Our pre-commercial activities continued as planned. FibroGen had its largest presence ever at the American Society of Nephrology Kidney Week Conference in October of last year, and there continued to be significant interest in Roxodusta from the clinical community. The momentum generated at ASN continues with additional analysis and plan disclosures of our Phase III data in order to maintain our HIF-PHI scientific and clinical leadership position. Patient and healthcare professional disease education activities are ongoing and expecting to increase through the official launch. Our partner AstraZeneca has a comprehensive renal commercial presence in the U.S., and together we're committed to make Ruxudustat available to as many CKD patients as quickly as possible to optimize patient access AstraZeneca is leading the discussions with both dialysis organizations and payers who cover non-dialysis patients. We have submitted manuscripts covering the phase three studies for CKD anemia to peer-reviewed journals. As you can see on the slide, five of these manuscripts have been published covering non-dialysis dependent, dialysis dependent, and insulin dialysis data. Details on these publications can be found in a press release, and we expect additional publications of Phase III data in the coming months. In Japan, our partner Astellas received an additional Evrenso approval for the treatment of anemia of CKD in adult patients not on dialysis in November of 2020. In addition, in December of 2020, the 14-day prescription rule was lifted for Evrenso. As a result of these two events, Astellas has seen and acceleration in Evrensos uptake. The European Medicines Agency accepted the Roxel-Dustad marketing authorization application for the treatment of anemia in adult patients with chronic kidney disease, both on dialysis and not on dialysis in May of 2020. We expect a decision mid-year. Now moving now to China. We're pleased to report net sales of Roxadusta of 29.2 million for the fourth quarter versus 22.7 million in the third quarter. The total net Roxadusta sales in China for 2020, the first year Roxadusta was included in the NRDL, were $72.5 million. The continuing increase in uptakes is being 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 efforts. Notably, as of the end of the year, Roxadustat was listed at hospitals represented approximately 70% of the CKD anemia market opportunity in China. This is in comparison to 55% at the end of the third quarter. We're driving towards our goal of making Roxadustat the number one treatment option for anemia of CKD patients in China. We continue to see significant Roxodusta utilization across a range of anemia of CKD patient populations. Approximately 60% of patients treated with Roxodusta in China are on dialysis, split between hemodialysis and peritoneal dialysis. Within hemodialysis, initial adoption has been in patients who do not respond well to ESAs, as well as in insulin dialysis patients. The remaining 40% of Roxadustat-treated patients are CKD anemia patients, not on dialysis. This broad utilization pattern bodes well for long-term success and provides critical learnings as we prepare to launch Roxadustat in the U.S. and in other countries. We look forward to keeping you updated as we advance our long-term goal of making Roxadustat the standard of care in treating China's CKD anemia patients. Moving now to our clinical development. On our third quarter earnings call, we provided timeline guidance for most of our clinical trials. We are reiterating that guidance today and do not intend to update this guidance on a quarterly basis, but it's only where we have meaningful changes, starting with Roxodustat. We recently completed enrollment in Whitney, our phase two trial in patients with chemotherapy-induced anemia, and top-line data is expected in the second half of this year. Upon conclusion of this trial is successful, we plan to initiate a phase three program in collaboration with AstraZeneca and Astellas. Matterhorn, our phase three trial in patients with anemia of myelodysplastic syndromes, or MDS, continues to enroll with top line data expected in the first half of 2022. Finally, we recently completed enrollment of Aspen and Denali, our two phase three B studies of Roxadustat in CKD anemia with large dialysis organizations in the United States. Moving now to pembrelumab. In locally advanced and resectable pancreatic cancer, our LAPIS phase 3 trial is enrolling well, with top-line resection data expected in the second half of 2022. Moving to Duchenne muscular dystrophy, enrollment continues in our LELANTUS phase 3 trial, In non-ambulatory patients, we top-line data also expected in the second half of 2022. Finally, in idiopathic pulmonary fibrosis, we recently initiated our Cephris-2 phase 3 trial in December. IPF patients have severely compromised lung function, and the current COVID situation continues to be extremely challenging for enrollment in both our pre-volta trials, Cephris and Cephris-2. Despite these circumstances, we have activated a significant number of additional clinical trial sites and expanded geographically, including in China, such that when COVID improves, we should be in a position to accelerate enrollment in both trials expeditiously. Given the different COVID scenarios, there is variability in our projected IPF timelines, and we'll provide you with an update at the appropriate time. Accelerating enrollment of all of our ongoing clinical trials while ensuring patient safety continues to be a top priority. Now let me touch briefly on the application of our pioneering expertise in hypoxia, inducible factor, or HIF, 2-oxoglutarate enzymology, and connective tissue growth factor, or CTGF, biology in order to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. In 2020, we completed a thorough internal review of all of our programs, and we plan to continue advancing internal molecules in our development pipeline. In addition, we are seeking to access external innovation. Finally, it is my pleasure to address another important accomplishment, the hiring of significant leadership talent, which includes the appointments of Dr. Percy Carter, a chief scientific officer, Dr. Mark Eisner, a chief medical officer, and Zane Wettick, a chief commercial officer. In summary, 2020 was a productive transitional year, and I look forward to more progress against our third goal in 2021. I will now turn the call over to our CFO, Pat Cotroneo, for the financial update. Pat?

Thank you, Enrique. As announced today, total revenue for the fourth quarter of 2020 was $65 million, and as compared to $8 million for the fourth quarter of 2019. The current quarter revenue consists of net product revenues of $29.2 million for ROXADUSTAT sales in China, $21.5 million in development revenue, and $14.3 million in license revenue related to NDD approval in Japan. For the same period, operating costs and expenses were $123 million the net loss was $58.6 million, or $0.64 per basic and diluted share, as compared to operating costs and expenses of $108.4 million and a net loss of $98.1 million, or $1.12 per basic and diluted share for the fourth quarter last year. Included in operating costs and expenses for the quarter ended December 31, 2020, was an aggregate non-cash portion totaling $26.9 million, of which $20.3 million was a result of stock-based compensation expense as compared to an aggregate non-cash portion of $22.1 million, of which $17.4 million was a result of stock-based compensation expense for the same period in the prior year. At December 31, Fibrogen had $732.1 million in cash, cash equivalents, restricted time deposits, investments, and receivables. At this time, I would like to outline some changes in financial reporting starting next quarter that result from the amendment to our China agreement with AstraZeneca. As we have previously reported, the amendment is expected to result in earlier and more consistent profitability to Fibrogen based on a continued 50-50 profit share with AstraZeneca. Under the amendment, we have formed a jointly-owned distribution entity, the JDE, that began operations in Q1 2021. The JDE will be responsible for selling Roxadustat to distributors and will pay for AstraZeneca's commercialization efforts in China and AZ's portion of profit share. Previously, Fibrogen was responsible for these items. The JDE is expected to account for over 95 percent of overall China Roxodustat sales volume going forward, while the rest will continue to be conducted directly by Fibrogen. Starting in Q1 2021, Fibrogen's revenue will be based on sales to the JDE at a transfer price as well as Fibrogen's direct sales. The transfer price is expected to be in the range of 30 to 45 percent of JDE net sales, which reflects the JDE paying both AstraZeneca's commercialization expenses and AstraZeneca's portion of the profit share. In addition, to continue to provide context for the operating results of our Roxodustat business in China, We also plan to share the overall net sales of Roxadustat, i.e., the combination of end sales by AstraZeneca and end sales by Fibrogen. Looking ahead at our broader financial picture, we have a total of $245 million of potential milestones expected this year 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 in any of the anticipated milestones between now and the end of the year. Based on our latest forecast data, we estimate our 2021 ending balance of cash, cash equivalents, restricted time deposits, investments, and receivables to be in the range of $660 to $670 million, assuming U.S. and EU approval in 2021. Thank you, and I would now like to turn the call back over to Enrique.

In closing, this is an important time for FibroGen. Roxadustat has launched in China, Japan, and is under regulatory review in the U.S., Europe, and other geographies. Panbrelumab is a wholly-owned potential first-in-class new medicine in Phase III development in the three high-value indications of locally advanced and resectable pancreatic cancer, Duchenne muscular dystrophy, and idiopathic pulmonary fibrosis. We are re-energizing our research agenda to deliver on our unique scientific expertise. In parallel, we're building world-class research capabilities internally, while also looking externally for opportunities, with the goal of expanding our pipeline of innovative drug candidates. We have strengthened our leadership team, which will be instrumental for our strategic growth. We are in a strong financial position as Roxadusta sales ramp up with approximately $732 million in cash and another $245 million in anticipated Roxadusta milestone payments expected during 2021. Looking forward, I believe we're clearly positioned for success. Now I would like to turn the call back to the operator for questions.

As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound or hash key. Again, ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your telephone. Your first question comes from Joel Beattie from CT. Your line is open.

Hi, thanks for taking the questions. The first one is, are you able to share anything about the topics that you're preparing to address at the EDCOM?

Thank you, Joel. Let me provide just a brief answer. I'm going to ask also Mark Eisner to comment. But clearly, at this point in time, we're not in a position to provide answers an update on that. As you know, there's typically a report that the FDA will basically make public prior to the outcome that's only a few days before the outcome is actually held. We don't have a set date for the outcome at this stage, and we do not provide to comment on a regulatory's interactions with the FDA. Mark, I'm going to ask Mark Isern if he has any additional comments.

Mark Isernberg Yeah, no, and thanks for the question. As you know, the FDA uses advisory committees to bring in external scientific, clinical, or other perspectives into its review, and it would not be unusual to have an adcom for a first-in-class new molecular entity. In this case, what's surprising is the timing, as Enrique had alluded to in his introductory comments. At this point, we're going to resume our preparation activities for the advisory committee. And we'll look forward to presenting the comprehensive Roxidustat program and its data. We continue to have confidence in the completeness of our NDA submission, the strength of our data, and along with our partner, AstraZeneca, we're committed to working together with the FDA to bring Roxidustat to patients with anemia of CKD in the U.S. So thanks again for the question.

Thanks. And maybe one follow-up to that. Can you share anything about how you and AstraZeneca collaborate for the ad-cam preparations and if there's one company taking the lead?

Yeah, this is really a... It has been a joint effort, a joint process. Clearly, AstraZeneca has considerable expertise when it comes to ad-cams, and we need to make sure that that is being fully leveraged. But I think the... When we were preparing back in the spring, that was the case, very collaborative. I expect that it will continue to be very much a joint effort.

Great. Thank you very much.

Your next question comes from Michael Yee from Jefferies. Your line is open.

Hi, guys. Thanks. Two questions for you guys. you can understand that people are, I guess, confused and a bit perplexed by the timing and also just the chronology of how things are played out. So the first question is just maybe, Enrique, can you just give us some comfort such that the discussions here or the debates or the issues here are more of a labeling and black box safety scenario question, you know, such that whatever happens here, you don't believe that peak sales are likely to change too much. You've kind of made that comment before, but you know, maybe you could comfort us in some way. The second question is more of a logistical question for the team. I think that you can't really have two formal PDUFA extensions if you go look at documents. So do you just expect that we're going to pass the PDUFA date, have to deal with an adcom, and then we just kind of go from there? Or do you expect that PDUFA would actually be formally changed so we would have some visibility on things? Thank you.

Yeah, thank you for your question, Michael. Clearly, I think, let me try to address maybe the first part, the last part of your question. Our understanding is that the PDUFA date can be extended once that extension happens. So at this point in time, we expect that the PDUFA date will be missed. And therefore, we will have the outcome at some point in time, but with no longer basically an active PDUFA date. I think the first part of your question was related to being more specific on the nature of the outcome. Clearly, when it comes to outcomes, outcomes are looking at the overall benefit-risk profile of the product, of course. They try to get external scientific expertise to bear. But I'm not in a position to be able to comment on the nature of that, and I think we have to prepare for it. And we want to see, of course, when this outcome will be scheduled. We don't have a set date for it at this time. Keep in mind that we were notified of this today.

Whoa. Okay. Thank you. Your next question comes from Edwin Zhang from H.C. Wainwright, Jordan, Ethiopia.

Hi. Thanks for taking my questions. First one, how much do you think is this ad hoc decision related to the new analysis you submitted to the FDA two months ago? And second, just follow up on the PDUFA date. Just to clarify, are you going to get a new PDUFA date from the FDA or not? And when are we going to know the new PDUFA date, if there's one? Thank you.

Yeah. Yeah, we don't believe there will be a new PDUFA date, given that there was already an extension. And I am sorry, I missed the first part of your question.

So how much do you think this adcom decision from the FDA is related to the new analysis you submitted to the FDA two months ago.

Yeah.

We don't want to speculate. Okay. Maybe one more. Does this regulatory decision change your expectation of a clean or differentiated label compared to ESA?

Yeah. Listen, I think at this point in time, we have to go through the outcome. We have a products with significant amount of clinical data. Keep in mind there are pivotal data for the U.S., including over 8,000 patients. We've discussed that clinical data at length. We continue to stand behind our data and the strength of the data. Some of the data now has been published. There are five primary manuscripts that have been published and a number of more that are upcoming. But at this point in time, I don't want to speculate on the nature of the ATCOM, we very much look forward to have the opportunity to share the ROCS-adjusted data in a public forum.

Great. Good luck on the ATCOM. Thank you.

Your next question comes from Jeffrey Porges from SBB Living. Your line is open.

Yes, thank you. A number of questions. related to this topic. First, Enrique, you're answering a lot of these regulatory questions. It would be helpful if the official regulatory representative for Fibrogen could answer the questions. But why doesn't this amount to a complete response letter to your application? And particularly given the amount of time it's going to require to prepare a full company package and the FDA's package, it would seem certain that it's going to be much more than 30 days. after the prior producer date. Secondly, it's going to certainly be hard for us and investors to be confident in your approval since, as far as we know, you've replaced most people in the organization who are familiar with the very extensive amount of clinical data. And then lastly, could you confirm whether this review or the whatever the outcome is going to be, will it be held by the hematology division or the cardiorenal division, and will it be examining and hearing the objections from the citizens' petitions? Thank you.

Yeah. So let me try to address some of your questions. I'm going to also ask Mark Eisner to maybe make some comments that he has received. formal chief medical officer also has regulatory responsibilities. First, the advisory committee we believe is going to be the cardio renal advisory committee. So that's how we understand it based on the communication with the FDA which happened today. I think you are making reference to Peony Yu's retirement as chief medical officer. Keep in mind that Peony is still an employee of Fibrogen at this stage, and she also has an agreement, a consulting agreement, over the next six months post her employment here at Fibrogen to continue to provide advice I feel that the strength of our team is considerable when it comes to roxodustin data, not just here at Farberton, but also at AstraZeneca. And then I'm going to ask Mark Eisner to also provide some additional comments or add to what I'm sharing. Okay.

Yeah, thanks Enrique. So the FDA did not issue a complete response letter. A complete response letter would indicate that the FDA had completed its review The FDA review of our NDA is continuing and ongoing, and the FDA wants to have an advisory committee in order to bring external expertise, clinical, scientific, and otherwise, into their review so that they can complete their review. So, you know, it's a very different scenario to get an advisory committee compared to a complete response letter. I mean, to address the specifics of your timing, yes, it's – it's a little late in the game in the review process to get a request for an advisory committee, but the FDA is well within its rights and regulations to request an advisory committee at any time, and we're very willing and able to have this discussion in public and present our data, which, as we alluded to before, we're quite confident in.

Mark, sorry, was this a change in the reviewing division, though, from the heme to the cardiorenal?

There was no change in the reviewing division, no.

Okay, thank you.

Your next question comes from Annabel Sanini from Stifel. Your line is open.

Hi, thanks for taking my question. I promise I won't ask about the adcom because it doesn't seem like you can answer many of them, but maybe we can talk about some of the signals that you're getting at CUS. Obviously, Sales in China are going well. The mix of sales dialysis to non-dialysis is improving. Japan was approved in non-dialysis. Even the French issued temporary use authorization with treatment up to 12 grams per deciliter. So how should we read these signals abroad and how can that help you? And frankly, help you with the FDA. to move this process along? Can you draw from all of that information that's being generated globally? And given some of the movement that we're seeing in China, are you still assuming a 500 million opportunity in China, or is that a moving target? Thanks.

Yeah. No, I think what we've said is that we're very excited, by the way, with the way our China business continues to progress. We have stated that we view the opportunity in China to be able to reach, for Oxford Duster, to be able to reach peak sales north of half a billion dollars. It is pretty clear that the launch continues to go very well, and we expect continued growth in China as we look at 2021. So we're very excited about that. We are indeed, we of course... conduct pharmacovigilance activities in both China and Japan where the product is launched. And we, as you mentioned, we need to make this also matter when it comes to the evidence that we basically have and how the acceptance and adoption and the utility that the patient basically has in the countries where we're launching. So I think this is an important factor, of course.

Operator?

Your next question comes from Jason Burberry from Bank of America. Your line is open.

Hey, guys. Thanks for taking my question. Just from a timing perspective, just so as we think about potentially modeling the timing implications here, so it sounds like it's a moving target with at least a 55-day notice period. Will they let you know in terms of timing from that to an ad comms? I would assume at least to be safe three to six months as a delay here. I'm not sure if you want to comment on those timing considerations. And I realize it's been a very short amount of time since you've had to digest this information, but any analog situations that you may have looked at or come aware of as it pertains to a novel that and anything that might give you or us some sort of comfort as it pertains to this situation in general. Thanks.

Yeah, no, thank you very much. We are, quite frankly, in unprecedented territory when it comes to having had an extension and then within the extension period now having, you know, an outcome. Clearly not... not a good situation from a timing perspective. We don't question the possibility or the wisdom of having an outcome. In fact, we had very much shared that we were preparing for that back in the spring, but an outcome was not called. So now we find ourselves very late in the process. And at this point in time, we have to look forward to try to prepare for in the best way possible, to ensure that we can have the most successful outcome possible and sharing all of our data and why we have the confidence that we have on Ruxus Dustat. So we will be looking, of course, at other types of examples and so forth and learning from that as part of the outcome preparation. I don't know, Mark Eisner, if you want to add anything to what I said.

No, I think you summarized it well, Enrique. I mean, we don't know the date of the outcome yet, so it's difficult to speculate on the exact timeframe. But we'll be preparing carefully. We'll be ready for the discussion. And we actually welcome the input from nephrologists and the external medical and scientific community. Just the timing was surprising.

Sure. Okay. Understood. Thanks so much.

Your next question comes from Yaron Werber from Coven. Your line is open.

Yeah, hey, thanks for taking my question. So, Enrique, I just have maybe a couple of questions. Number one, I was under the impression that the original NDA was sent to hematology. So is it that hematology asked CardioRenal for advice and the CardioRenal Epcom was called? It sounds like they didn't send the application across to a different division, but it sounds like they're calling an outcome from another division and not totally surprising given that division has experienced at least with ESAs. And then secondly, as you think about OPEX and for this year, and I know you don't give guidance, but can you give us a little bit of a sense what's going on with IPF is a little slow because of COVID, but just a little bit, how do we think about OPEX? Thank you.

Yeah. So, um, Yeah, your understanding is also the understanding that I had on both hematology and renal. They are both under the same overall leadership at FDA, but we were informed today that cardiorenal would be the one basically conducting the outcome or hosting the outcome. Sorry, I missed the second part of your question was related to COVID. Were you asking about operating expenses?

Exactly, yeah. Some of the R&D would have been IPF-related, but that's slower to ramp. So just how do we think about the OPEX for the year overall and maybe a little bit of R&D? Thank you.

Yeah, we, of course, are looking at our operating expenses. We do this as a matter of discipline. Whenever we had even the three-month extension, I asked for an overall review of our operating expenses. Given that we were going to be launching blocks-induced later, now we need to undergo a similar process now that we have a further delay. Clearly, when it comes to PAM, we're trying to enroll as quickly as we can, but we need to be thoughtful about every single expense here at Fibernet. We do have a good balance sheet and a good position, but we need to make sure that it's invested in the things that can add the most value at all times and continue to have operating discipline anytime things and some of the assumptions change.

Great. Thank you so much.

Your next question comes from Andy Shea from William Blair. Your line is open.

Oh, great. Thanks for taking that question. I'm just wondering, you know, high level, you know, heading into the adcom, what's your confidence level, right? So basically, you know, before it's kind of a two-party interaction between you and the FDA, the venal cardio division, and now, you know, they're bringing in, you know, a third-party external, you know, expert, you know, kind of democratizing the process. So maybe comment on the... the confidence level and the ability for you to kind of highlight the data in that avenue. And also for the preparation, for incidence dialysis, is that kind of a separate population that you would want to kind of single out during the presentation?

Yeah, clearly I won't be sharing what are we planning to present and so forth, but you can imagine, of course, the data that we have on incident dialysis we believe is some of our strongest data as we think about MACE and MACE Plus significance in that population. So clearly very, very important data. What I would share, I think, you talked about democratizing the process, transparency, but I think it's also a good opportunity to get the external community, including nephrologists, patient advocates, to opine about some of the needs out there. And I think, honestly, I think in that way, I think this... the outcome could be refreshing to be able to hear some of the interest that the clinical community has in the product. That's what we hear, basically, whether it's at ASN, either directly, shared comments, but also how interested people are in the different presentations that we had, whether were oral presentations or posters at ASN. So I look forward to the full engagement of the scientific community. So that's the perspective that I would provide.

Okay.

Thank you.

That's helpful.

Your next question comes from Paul Choi from Goldman Sachs. Your line is open.

Hi, this is Aliza on for Paul. Thanks for taking the question. A quick one on the adcom for us. It seems that previously the FDA was reviewing Roxa in terms of both the DD and NDD populations together. With the new news on the adcom, are you guys still expecting a similar review? Do you have any indication that the agency might review these populations and or indications more separately? How you're thinking about that would be great. Thank you.

Yeah, I will have Mark Eisner maybe comment and respond to that question.

Yeah, so it's a great question. Thank you. We can't really obviously share the details of the FDA's overall intent because we don't want to speculate, but we're very confident in our data for both populations. I mean, the data are the same today as they were yesterday, and we had the FDA tell us today about the outcome. So we continue to feel very confident in the data. And as Enrique said, I think it's it's actually, although the timing is unfortunate, it's a great opportunity to really hear from the community, whether they be patients and their advocates, nephrologists, other clinicians, about how important and innovative this product is and can be for patients. And there's been very little innovation in this space over the past 30 years for CKD anemia, and we really believe the Roxidustoc can provide really significant clinical benefit to patients in both populations. So we're looking forward to that discussion in the public venue.

Got it. Thank you.

Your next question comes from Difei Yang from Mizuho Securities. Your line is open.

Hi. Good afternoon, and thanks for taking the questions. So just three quick questions. One, I apologize if I missed that. are you expecting the 55-day prep time leading up to EDCOM, or will it be shortened in some fashion? Then the second question is that would you have the option to call back CMO for this EDCOM, or do you think she will not be there? Then the third question is with regards to EMA, I think you have said you're still expecting decision mid-year 2021. I'm wondering if you are able to give us a little bit more detail between now and approval, what other things needs to happen?

Yeah. I'm going to have Mark Eisner respond to these questions and I'll compliment his answers.

Right, so in terms of your first question about the 55-day prep time, the FDA has not provided us a date for the advisory committee, and as soon as they do, we'll be able to communicate that. But we would assume that they're going to conform to their typical practices. In terms of calling back the CMO, Dr. Pioniu will continue to be working as a consultant for us for the next six months, so we'll have access to her expertise. And remember, the expertise on this product, although Dr. Yu is very expert, is deep and broad within both FibroGen and AstraZeneca. So we're very confident that we will be able to bring a very appropriate and invigorated discussion at the time of the outcome. And then in terms of the EMA, yes, there's been no change to our expectations around the mid-year approval for Oxidustat in the European Union.

Operator?

All right. At this time, I would like to turn it back to the speakers for further comments. I'm showing no further questions at this time. Please go ahead.

We appreciate everyone's participation in today's investor call and your interest in Fibrogen. Please follow up with our investor relations team if you have any questions we have not addressed on the call and enjoy the rest of your day. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating.