FGEN (2021 - Q1)

Good day and welcome. Thank you for standing by. Welcome to the FibroGen first quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]. Please be advised that today's conference is being recorded. [Operator Instructions]. I would now like to hand the conference over to your speaker for today, Mr. Michael Tung. Please go ahead. Michael

All right. Thank you Erica and good afternoon everyone. And welcome to FibroGen's conference call for our fiscal 2021 first quarter 2021 financial results. I am Michael Tung, 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; Dr. Mark Eisner, our Chief Medical Officer;, Thane Wettig, our Chief Commercial Officer; Chris Chung, our Senior Vice President of China Operations; and Dr. Elias Kouchakji, our Senior Vice President of Clinical Development, Drug Safety and Pharmacovigilance. The format for today's call includes prepared remarks from Enrique, after which we will open up the call for Q&A. I would like to remind you that remarks made on today's call may include forward-looking statements based on FibroGen's current expectations. Such statements may include, but are not limited to, statements regarding our collaborations with AstraZeneca and Astellas, financial guidance, the initiation, enrollment, design, conduct and results of clinical trials, our regulatory strategies and potential regulatory results, our research and development activities, commercialization and results of operations, risks, plans market opportunity and strategy related to our business, our planned FDA advisory committee meeting and other anticipated FDA interactions and certain other business matters. Such forward-looking statements are subject to significant risks and uncertainty that could cause actual results and events to differ materially from those anticipated in such statements. For a discussion of these and other material risks and factors that could affect our future financial results and business, please refer to the disclosure in today's press release reporting our fiscal 2021 first quarter financial results and business update, our most recent forms 10-K and 10-Q and reports that we may file on 8-K with Securities and Exchange Commission. All those statements are made as of today, May 10, 2021 based on information currently available to us. And FibroGen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Today's press release reporting our fiscal 2021 first quarter financial results and business update and a webcast of today's conference call can be found on the Investors section of FibroGen's website at www.fibrogen.com. With that, I would like to turn the call over to Enrique Conterno, our CEO. Enrique?

Thank you Mike, and good afternoon, everyone, and welcome to our first quarter 2021 earnings call. Today, I would like to provide a high-level summary of most important accomplishments and developments in recent months. Pat Cotroneo, our CFO, would then review the financials, after which we will open up the call for your questions. I reiterate my assessment that FibroGen is uniquely positioned to create significant value for patients and shareholders by executing on the three areas of focus, as shown on Slide 2. Number one, ensuring regulatory and commercial success of roxadustat, a transformational medicine for the treatment of anemia, first in patients with chronic kidney disease, but with significant potential for expansion to treatment of additional indications. Number two, accelerating the development of pamrevlumab in three indications with significant unmet medical [Technical Difficulty] advanced unresectable pancreatic cancer, Duchenne muscular dystrophy and idiopathic pulmonary fibrosis. And number three, the strengthening research productivity by leveraging our leadership position, both in hypoxia-inducible factor and connective tissue growth factor biology and by accessing external innovation. Today's call will include a review of roxadustat, our continuous strong performance in China and our clinical trial programs. Let us get started with roxadustat U.S. new drug application or NDA review. In March, we announced that the FDA has decided to hold an advisory committee meeting for the roxadustat NDA. Our team remains focused on preparing for the upcoming advisory committee meeting, which is tentatively scheduled for July 15. In April, we made an announcement clarifying for the FDA at the medical and investment communities certain prior disclosures of primary cardiovascular safety analysis from the roxadustat Phase III program for the treatment of anemia of chronic kidney disease. Our meeting with the FDA was productive and we have had further productive discussions with them regarding the outcome. Importantly, this clarification does not impact our overall conclusions regarding the comparability with respect to cardiovascular safety of roxadustat to epoetin-alfa in dialysis-dependent patients and to placebo in non-dialysis dependent patients. As described on April 6, for the incident dialysis subgroup, based on the pre-specified stratification factors, roxadustat is comparable but not superior to epoetin-alfa with regards to cardiovascular safety. We look forward to publicly discussing the analysis of the cardiovascular safety data at the advisory committee in July. We have reached out to key opinion leaders, primary investigators and medical journalists to discuss this matter and the discussion thus far have been productive and appreciated. We continue to progress our internal review expeditiously and we will communicate at appropriate time. Importantly, we are putting controls in place to prevent this type of occurrence in the future. I want to reiterate that we continue to have confidence in the roxadustat data and in the safety and efficacy profile demonstrated in the Phase III program. FibroGen and AstraZeneca are committed to working together with the FDA to bring roxadustat to patient with anemia CKD in the U.S. Our pre-commercial activities have continued. FibroGen recently presented additional analysis at the National Kidney Foundation, the Spring Clinical Meetings and the ISN World Congress of Nephrology and there continues to be significant interest in roxadustat from the clinical community. Healthcare professional disease education activities are ongoing and expected to increase through the official launch. Our partner, AstraZeneca, has a comprehensive renal commercial presence in the U.S., but together, we are committed to make roxadustat available to as many CKD patients as quickly as possible. In order to ensure patient access, AstraZeneca is leading the discussions with dialysis organizations and with payers who cover non-dialysis patients. We have submitted manuscripts covering the CKD anemia Phase III studies to peer-reviewed journals. As noted in Slide 3, six of these manuscripts have been published encompassing both non-dialysis-dependent and dialysis-dependent data and we expect additional publications of the Phase III data in the coming months. Astellas recently reported their fiscal year 2020, which ended in the calendar year first quarter. They guided to total EVRENZO sales of approximately $80 million for the fiscal year 2021. And this guidance includes EVRENZO sales in both Japan and Europe. In Europe, we continue to expect a mid-year decision by the European Medicines Agency on the marketing authorization application for roxadustat for the treatment of anemia in both dialysis and non-dialysis patients with chronic kidney disease. Moving now to China on Slide 4. We are pleased to report total roxadustat net sales to distributors in China of $43.5 million for the first quarter versus $29.2 million in the fourth quarter of 2020. The increase in uptick continues to be driven by both an expansion in hospital listings and broad adoption within listed hospitals. Under the revised partnership structure, FibroGen reported $15.4 million in China roxadustat net product revenue for the first quarter of 2021. As we have previously disclosed, beginning the first quarter, our jointly-owned distribution entity or JDE is responsible for selling roxadustat to distributors and will pay for AstraZeneca's commercialization efforts in China and AZ's portion of the profit share. Previously, FibroGen was responsible for these items. The JDE is expected to account for over 95% of overall China roxadustat sales volume going forward. The rest will continue to be conducted directly by FibroGen. Hospital listings continued to be a key focus of our launch efforts. Notably, at the end of the first quarter, roxadustat was listed at hospitals that collectively represent approximately 74% of the CKD market opportunity in China. As you can see on Slide 5, interestingly, since the inclusion of roxadustat on the NRDL, the ESA market growth has accelerated. In fact, ESA revenue over the last six months has shown 21% growth over the same period of the prior year. Moving to Slide 6. Roxadustat has expanded the anemia CKD category over the past 14 months, which translates into roxadustat adding new patients to the anemia CKD category. Combining this view of roxadustat uptick, along with the growing ESA category as shown on the previous slide, it is evident that roxadustat is growing share in an expanded market, which is a great sign. Finally, as shown on Slide 7, roxadustat is the number one branded treatment for anemia of CKD in China for each of the past two months with a 27% value share in the segment that includes all ESA products on roxadustat, currently the only HIF-PHI on the market. We continue to see significant roxadustat utilization across a range of anemia of CKD patient population. Approximately, 65% of patients treated with roxadustat in China are on dialysis covering hemodialysis and peritoneal dialysis, while the remaining 35% are not on dialysis. This broad utilization pattern bodes well for long term success and provides critical learnings as we prepare for the launch of roxadustat in the U.S,, Europe 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, including China's CKD anemia patients. Moving now to our clinical developments and starting with roxadustat. During the quarter, we completed enrollment of our Phase II chemotherapy-induced anemia or CIA trial. In ASPEN and DENALI, our two roxadustat Phase IIIb studies in CKD anemia patients conducted with U.S. dialysis organizations, many patients have transitioned now into the extension phase. We expect to present topline data at a future medical meeting. Moving now to pamrevlumab. In March, we announced the initiation of LELANTOS-2, our Phase III randomized, double-blind, placebo-controlled trial of pamrevlumab in ambulatory patients with Duchenne Muscular Dystrophy. Pamrevlumab was recently granted fast track designation and rare pediatric disease designation from the U.S. FDA for the treatment of DMD. We value this acknowledgment of the serious and life-threatening manifestations of this rare disease and support of our mission to provide pamrevlumab as a potential treatment option for DMD patients. I will turn now the call over to our CFO, Pat Cotroneo, for the financial updates. Pat?

Thank you Enrique. As announced today, total revenue for the first quarter of 2021 was $38.4 million as compared to $24.4 million for the first quarter of 2020. The current quarter revenue consists of $15.4 million in net product revenue for roxadustat sales in China, $14.6 million in development revenue and $8.5 million in drug product revenue for roxadustat bulk drug or active pharmaceutical ingredient. For the same period, operating costs and expenses were $108.9 million and net loss was $71.8 million or $0.78 per basic and diluted share, as compared to operating costs and expenses of $105.5 million and a net loss of $78.3 million or $0.89 per basic and diluted share for the first quarter last year. Included in operating costs and expenses for the quarter ended March 31, 2021, was an aggregate non-cash portion totaling $25.1 million, of which $19.4 million was a result of stock-based compensation expense as compared to an aggregate non-cash portion of $22.1 million, of which $16.9 million was a result of stock-based compensation expense for the same period in the prior year. At March 31, FibroGen had $682.6 million in cash, cash equivalents, restricted time deposits, investments and receivables. As mentioned in our last call, we have made some changes in financial reporting. Starting this quarter, the jointly-owned distribution entity between AstraZeneca and FibroGen or the JDE is responsible for selling roxadustat to distributors and pays for AZ's commercialization efforts in China and AZ's portion of the profit share. Previously, FibroGen was responsible for these items. As of March 31, the JDE accounted for over 95% of overall China roxadustat sales volume, while the rest continues to be conducted directly by FibroGen. As such, under this new structure, FibroGen reported $15.4 million in China roxadustat net product revenue for the first quarter of 2021 on a U.S. GAAP basis, which included FibroGen's revenue generated from our sales through JDE as well as our direct sales in China. To provide context for the operating results of our roxadustat business in China, total roxadustat net sales, including sales through the JDE to its distributors and FibroGen China's direct sales to our distributors, was $43.5 million for the first quarter of 2021. Looking ahead at our broader financial picture, we have a total of $245 million in potential milestones expected by the end of the 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 year-end 2021. Based on our latest forecast data, we continue to estimate our 2021 ending balance of cash, cash equivalents, restricted time deposits, investments and receivables to be in the range of $660 million to $670 million, assuming U.S. and EU roxadustat approval in 2021. Thank you. And now, I would now like to turn the call back over to Enrique.

In closing, this is an exciting time for FibroGen. Roxadustat continues to perform very well in China and is under regulatory review in the U.S., Europe and other geographies. Our team remains focused on preparing for the upcoming Advisory Committee Meeting that is tentatively scheduled for July 15 and we look forward to presenting the roxadustat data in a public forum. Pamrevlumab is a wholly-owned, potential, first-in-class new medicine in Phase III development in three indications with significant unmet medical need, locally advanced unresectable pancreatic cancer, Duchenne Muscular Dystrophy and idiopathic pulmonary fibrosis. Finally, we continue to advance our research agenda. We are delivering on our unique scientific expertise in strengthening and broadening our internal capabilities, while also looking for external opportunities with a goal of expanding our pipeline of innovative drug candidates. As shown on Slide 8, we are in a strong financial position of roxadustat sales ramp-up, with approximately $682 million in cash and another $245 million in anticipated roxadustat milestone payments expected during 2021. I would like to take a moment and also welcome Tricia Stewart, who we recently appointed as Chief People Officer at FibroGen reporting to me. She comes most recently from Genentech and will be responsible for advancing our people and culture strategy. Looking forward, I believe we are positioned for success. Now, I would like to turn the call back to the operator for questions. Erica?

Thank you so much. The floor is now open for questions. [Operator Instructions]. Our first question comes from the line of Annabel Samimy. Your line is open.

Hi. Thanks for taking my question. I am not sure if I missed the initial comments. But I was wondering if you could tell us if during the preparation for the AdCom, have you conducted analyses of any of the additional clinical benefits that were published or presented or claimed, like reduced RBC transfusion, regarding the inflammatory status with responders or better iron utilization? And can you feel comfortable that the data that you presented at those meetings are accurate? And then secondly, you had mentioned some critical learnings in China. Maybe you can highlight what those learnings are for us? Thank you.

Very good. Let me turn the first - your first question about roxadustat and the benefit risk profile to our CMO, Chief Medical Officer, Mark Eisner.

Yes. Thanks for the question. So yes, the answer to your questions is yes. We have confirmed the additional benefits in terms of hemoglobin increase with roxadustat, reduction in red cell transfusions, roxadustat having benefit in patients with high CRP and who are functionally iron deficient. So we have been able to confirm all those results and that has not changed since our April 6 press release.

Very good. Clearly, I think when it comes to China, I think the results in China, I think, I will call, nothing short of impressive and quite frankly, it gives us a lot of confidence for how roxadustat is becoming a better choice when it comes to treating anemia CKD patients in China across the continuum of both DD and NDD. There are a number of learnings that we are capturing from China. One of them, I think, I mentioned in the past was, we have seen a faster than expected uptick, in particular, in the NDD segment. And what we have basically seen basically also excellent feedback because when it comes to a launch, clearly, the first few quarters could be always impressive. But now I think we have a string of quarters where we have seen continued growth quarter-on-quarter that basically reflects not just the overall benefit risk profile of roxadustat that we discussed, but also the feedback from healthcare professionals and patients in terms of what roxadustat is offering in the real world. So I think it's very, honestly, we are very encouraged with that and the potential readthrough of that to other markets.

Thank you.

Your next question comes from the line of Michael Yee. Your line is open.

Hi. Good afternoon and thanks for the update. We had two questions. The first was, to the extent, you can talk about maybe topics of relevant areas of interest that you think will be discussed or could be a focus for the panel, that would be great since you sounded like you have had good ongoing conversations and things? Maybe you could shed some general light on how to think about that from an expectation standpoint? And the second was related which was, I know that it is being reviewed in terms of an AdCom from the cardiovascular-renal group. Is that a separate group that you have had dialogue with? Or how does that play into things in terms of ongoing discussions? Thank you.

Yes. I am going to have Mark Eisner try to answer both of those questions. And I will complement as appropriately. Mark?

Yes. So thanks for the question. So yes, we have been having cooperative dialogue with the FDA about the advisory committee. I think both the agency and FibroGen and our partner AstraZeneca want to make sure that we have a very fullsome discussion at this advisory committee and give the advisory committee members the information they need to fully understand the program. In terms of the themes, I think I’d largely characterize it around the benefit risk profile of roxadustat for patients with CKD anemia and just to further explaining the safety and the efficacy of the medicine for NDD and DD population and getting the input, particularly from expert nephrologists who treat patients with CKD anemia. So that's kind of a broad answer. But that's where we are with the agency at the moment. And in terms of, you mentioned that this will be a cardiorenal drug advisory committee, which it is. And yes, we have had conversations both at the office level with the cardiorenal, it's actually OCHEN, but includes cardio and renal and also with the benign hematology division. So we have had discussions at all those levels with FDA, including now the various stakeholders for both of these areas.

Yes. I will just maybe add that I think our preparations when it comes to the outcome, I think, are progressing well.

The reason I ask is because this is – supposedly, we’ll have renal or nephrology experts on there and you think that that would be a positive, yes? Because they would actually be experts on the panel rather than just people who are not familiar with that, is that a fair statement?

I think it is important to have nephrology experts, which I believe the FDA intends to have because they do treat patients with CKD anemia, both in the NDD setting and dialysis setting. So they are in a very good position to understand the unique attributes of roxadustat and where the benefit risk is going to be positive. So yes, I think it's going to be really important to have that nephrology input.

Got it. Thank you.

Your next question comes from the line of Edwin Zhang. Your line is open.

Hi. Thanks for taking my question. First one, can you please remind us the purpose and design of the ASPEN and DENALI clinical trials? How are the new study results going to affect or help the adoption of roxadustat in the U.S. dialysis organizations? And then I have a follow-up.

Sure. So the ASPEN and DENALI trials, they are single-arm, open-label studies conducting - conducted in large dialysis organizations that I think will provide an understanding of roxadustat in a more real-world clinical setting. It is a clinical trial. But it is one that's conducted in a setting that's very much a real-world clinical setting for hemodialysis patients. We are expecting to present data sometime by the end of the year in a scientific meeting. And for the all large dialysis organizations, I mean, the data, we are committed to making that available to them at their request, so they can further understand the value and the use of roxadustat in their patient populations.

Okay. My last question on pamrevlumab on DMD. Are we going to expect a publication of the Phase II study, including the two-year data? And what's your current thinking on the market opportunity of pamrevlumab in DMD? Thanks.

Yes. We will have Mark answer the question on pamrevlumab on Duchenne Muscular Dystrophy and questions, in particular, around the two-year data, on publishing that data.

All right. So we are in the process of working to get the two-year outcomes data published. So I don't have a specific date for you. We are working on that actively. And we do think that's important to show how the benefits continue between year one and year two.

And I think you were asking about the overall opportunity in DMD and maybe let me try to frame that in the context of the three programs that we basically have for pamrevlumab. We see each one of these opportunities, whether it's IPF, LAPC or DMD, as significant opportunities. The IPF opportunity, when we look at from clearly, I think it's important to say that the three of them are significant unmet clinical needs. The IPF opportunity is expected to be larger than other two, LAPC then and then DMD. But each one of those opportunities is significant on its own. And collectively, I think they do represent a massive opportunity. We expect that we will have the LAPC results and DMD results in the second half of next year from a readout perspective, while in the case of IPF, we have not shared that, but we expect to share at a specific time, I think, in the near future.

Thank you.

Your next question comes from the line of Jason Gerberry. Your line is open.

Good morning guys. Thanks for taking my questions. I guess just first on the slew of shareholder suits, can you just remind us sort of what's the burden of proof in these matters? I would assume the fact that the FDA is moving forward with an AdCom. It inherently implies there is some ambiguity around the safety and the upper bounds of the confidence interval on NDD. But just kind of curious if you can just provide a little bit of a helpful legal framework to think about the shareholder class action suits? And then my second question is just on DD, assuming approval, what I wonder about is as the second and third HIFs come to market, what are your thoughts that these dialysis organizations might look to hop from one product ending its NAPA phase and some of the financial benefits to the second and subsequent third products they may offer some of those financial benefits? Just thinking about the longevity of the dialysis launch? Thanks.

Yes. Thank you. I think on your first question, we do not comment on either ongoing or potential litigation. As far as your question about HIFs and how would second or third HIF, whenever it comes, impacts the contracting or maybe the dialysis organizations being able to move from one HIF to the other, a couple of comments that I will make. First is, clearly launching first is important. We have seen that across many different launches across different therapeutic classes, because you tend to establish yourself as basically the go-to-product, the product that healthcare professionals have the experience with. And then second, I think quite frankly there is no real experience in terms of or studies showing basically switches from one HIF to the other and who can say that that's going to work well. Keep in mind that at the end of day, we have to look at also the clinical data and how does the products basically compare overall. So there are number of variables. And I don't believe that we should be thinking, as we have seen in other therapeutic classes, that it's either appropriate or that it will be convenient to just basically switch products in large from one comp and to a different one for the same drug. I think there are lot of considerations that would have to be made.

Got it. Thanks.

Your next question comes from the line of Geoffrey Porges. Your line is open.

Thank you very much for taking the questions. My first one, I will ask a couple that you probably kind of wouldn't answer and then one that hopefully you can. The first is, in the discussions with the FDA, can you give us a sense of whether the basis for the labeling discussions is going to be the per-protocol stratification or the post-hoc stratification? That would be helpful. And then secondly, you have these Phase II and Phase III studies in CIA and MDS coming in the second half of the year and the beginning of next year. And then obviously those indications are completely different price points to the dialysis and non-dialysis indications where, of course, you have to think about the bundle rate and all that sort of thing. So have you had any further thoughts, Enrique, about whether you will price differentially to the different markets? And whether that's feasible? Or whether we should expect you to price pretty much in the same band? And then lastly for China, is the reported revenue under the new arrangement that comes into your results as a proportion of the total revenue in market, is that percentage likely to remain relatively constant going forward? Or actually increase? Or is it just going to be really bouncy? Thanks.

Yes. Thank you, Geoff, for your questions. Let me first state that when it comes to our interaction with the FDA, I think we are not really providing any detail when it comes to our interactions. Clearly, just in general, I think we expect that the FDA will be looking at the overall evidence, including what the primary analyses says and also on a number of sensitivities around some of those analyses. So far we feel good about our discussions with the FDA in that they are very productive discussions. In terms of your question around CIA and MDS, clearly when it comes to MDS, I think that's where the biggest price differential is. It's also in CIA but, of course, we are going to need to see when it comes to CIA based on the Phase II results, what is the dose and so forth and also what is that we are basically seeing. So I expect that CIA while there might be some slightly different price points, I don't view them as meaningful. In the case of MDS, there is a pretty significant difference between products and the markets being used for MDS basically would wield the price, for example, anemia or CKD with roxadustat. I think it's fair that we want to make sure that we are appropriately pricing so that we can, based on the value that the product or that the medicine is offering in the different populations. And while that is always the goal, we all know that that is a challenge in particular. It's a challenge in the U.S., how to effectively do that. So at this point in time, we are not commenting on how we are thinking about that. But clearly that has to be part of our strategic thinking just to ensure that we are appropriately receiving the value for what roxadustat is offering the different patient populations. Finally, you asked a question about the FibroGen reported revenue relative to the overall net sales to distributors between the joint distribution entity and FibroGen's indirect sales and whether that proportion that we reported this quarter, that is going to be the ongoing proportion going forward. There are number of factors that play into this. We provided some guidance, I think, during the last earnings call that we expected that number will be somewhere between 30% and 45%. We continue with that type of guidance. So I think it's going to bounce a little bit based on a number of different considerations. I think that bottom line here is when we look at the overall net sales of roxadustat through distributors, it is pretty clear I think that the product is having incredible performance and is really valued I think in terms of what it's offering patients in China.

Great. Thanks very much, Enrique.

The next question comes from the line of Yaron Werber. Your line is open.

Hi. Thanks very much for taking the questions, guys. This is Brendan, on for Yaron. Just a couple of quick ones from us. I think, first, looking at the growth of roxadustat sales in China, it kind of looks like January and February sales are maybe more or less flattish. Are there some specific drivers behind that that you can maybe identify to help us understand just some of the commercial dynamics at play there? And then secondly, just on the DENALI and ASPEN studies, I think you mentioned just now that we could get data from there maybe by the end of this year. If memory serves, I think we were supposed to see that data in Q1 of this year originally. So I guess, have there been any delays in enrollment or treatment there that you might be able to comment on? Thanks very much.

Yes. Okay. Let me try to address your question about China. And I think as you mentioned that sales in China maybe were, if I understood correctly, you said they were flattish in January and February. I don't think that's the case. For roxadustat, clearly, we are basically seeing increased share and we are seeing increased share in a growing market, right. So we feel very good about where we are. And when we look at our internal sales in the first quarter, clearly or the sales that we reported just right now with its overall net sales through distributors, I think we have seen a significant increase, north of 40% sequentially between Q4 of 2020 and Q1 of 2021. So I don't believe that's the case. And your second question was related to DENALI and ASPEN and I am going to have Mark Eisner answer for you.

Yes. I think that there is two different things. One is when, I mean, since it's an open label study, it's potentially possible to provide for the dialysis organizations data cuts for their own use. So that was starting Q1 possible. What I was talking about as a distinctive factor was when we expect topline data from the overall study to be available, that I think we have been consistent that should be by end of year at a medical meeting.

All right. Thanks very much, guys.

Your next question comes from the line of Difei Yang. Your line is open.

Hi. Good afternoon and thanks for taking my question. Just two questions. Circling back to the DENALI and ASPEN trials, would you be able to clarify if the sites, the clinical sites are mostly DaVita or Fresenius or it's a balance of the two? And the second question is related to AdCom. So what's the role for AstraZeneca for this AdCom? Is it primarily driven by FibroGen? Thank you.

Yes. Let me, just very quickly on the DENALI and ASPEN, we are not commenting on who are we doing those studies with. But as we said, it's clearly we are doing this with large dialysis organizations. And as far as the AdCom, of course, FibroGen is the sponsor. So we are the sponsor of the NDA. And maybe, Mark, you can provide some additional comments on the role of AstraZeneca.

Yes. I will describe it as a highly collaborative effort between FibroGen and AstraZeneca. We have essentially formed a joint working team to prepare for the advisory committee, to prepare the presentations and they are ready for the Q&A. So it's a highly collaborative process between both companies.

Thank you.

Your next question comes from the line of Paul Choi. Your line is open.

Hi. This is Lisa, on for Paul. Thanks for taking the question. A quick one from us. Now that pamrevlumab has fast track and rare pediatric disease designation for its DMD program, can you walk us through how you are thinking about any updating timing in this program, regulatory and potentially commercial as well? Thank you.

Yes. Maybe I will make some initial comments and Mark will add some additional color. Clearly, I think the key for us when it comes to ensuring that we can complete our DMD and be able to bring this medicine to patients is really the enrollment of our trial. So we are working very closely, o diligently to try to ensure that the enrollment in DMD for both of our trials can happen as quickly as possible. To that end, we have added a number of additional sites, including now in China, where we have gotten the approval and we started basically recruiting patients in DMD as well that will contribute to the overall global program. So we are excited about those designations. I think the designations generally basically allow for basically more interaction with FDA, in this particular case, in relation to this program. And I think that's a benefit from a regulatory review process and can provide the basis to be able to move quickly, more quickly and resolve any type of issues in a prompt manner. Mark, any additional comments?

No. I think that was well stated, Enrique. I mean, I would say both the fast track and the pediatric rare disease designation from FDA speak to the high unmet medical need and the potential of pamrevlumab to help patients with better outcomes with this high unmet medical need. I think it helps us in terms of enrolling the trial, because it's just another way of highlighting how important these studies are. So overall, I think it's a real positive for our ability to enroll these trials and to focus on doing it expeditiously.

Great.

Thank you. The next question that we have is from the line of Andy Hsieh. Your line is open.

Great. Thanks for taking my question. So I have two questions regarding the China market dynamics, maybe for Chris. So the trajectory in terms of hospital listings has been very impressive. So I am just curious, as you kind of reach going from about 74% to 80% to 90%, even high 90%, what are some drivers that your team is thinking about in terms of continuing to grow that revenue line? And also in terms of the kind of the periodicity of the natural reimbursement dynamic, I think every single year there is kind of scheduled pricing cuts mandated by the government. I am just wondering what the FibroGen China team is thinking about in terms of kind of preparing for that? Thank you.

Yes. I think I will have Chris indeed address both questions when it comes to drivers for revenue growth going forward in China. We tend to increase, there is a limit to, given how well we have done with hospital listings, in terms of how much will that continue to contribute. And then also I think you made a question about the NRDL. And I would say the negotiation for products happens every two years, not every year, although every year there is some product that will be negotiated. Chris?

Sure. So to answer the first question, we think of hospital listings as market access. So until you list it in a hospital formulary, no physician can dispense. So once you get your foot in the door, in the case of roxadustat, you still need to convert the prescribers one at a time. So let's say, there are 35 nephrologists in a department. You don't get all 35 in the first day, you might get five. The next you might get 10 and hopefully, there's an upward trajectory. And for every single prescriber, let's say, they have 200 patients. If you also don't get the 200 on the first day, you might get 20 and then you might get 25%, you might get 50%. Obviously, if we were successful, we would love to get the vast majority of prescribers and the vast majority of their patients. But there is some arc to the trajectory. So we see getting our foot to the door in terms of the success we have in hospital listings to bode very, very well for future adoption. But really we are at the very, very beginning of market adoption of roxadustat. So, 74% is very good, which means that 74% of the potential market could actually get access to prescription. But that doesn't mean that that's the end of the uptake. I hope that makes sense. The second question with regards to NRDL, Enrique is actually correct. It's renewed every single two years. So roxadustat will be up for price negotiations in Q4 of 2021 and the new price will become effective in 2022. There are obviously a number of factors that they would consider in the price. First is the budget impact of roxadustat on the national healthcare budget. The second is the value proposition of how much we actually save in healthcare costs and many other factors in the value proposition. And third is really how strong is the market adoption and how much prescribers value this drug. We remain confident in the outcome of price negotiations. To be clear, the price only goes in one way. It always goes down. It never goes up. So it's the discretion of the NRDL in terms of how they value it and how much it comes down. Every single year, they come up with a different set of criteria for determining pricing. The 2019 one was different from 2020. The 2021 eligibility criteria and prioritization has not yet been announced. We are working very closely with market access at AstraZeneca to demonstrate the value of our drug and we remain confident about a very good outcome in Q4 of this year for the price that will be effective for two years thereafter.

Hi. Chris, this is Thane. If I could just maybe piggyback on to your answer on the China trajectory to provide some more color on Andy's first question. This is really the first time we have provided some granularity around China performance over and above revenue and then snapshots of hospital listings and things of that nature. And so if you take a look at some of the slides that we provided, the first thing to reiterate is, we have got a market that when you add the ESA growth on top of the category expanding nature of roxadustat, it's a market that's really taken off, which really highlights the promotional responsiveness to this category. And then when you take a look at the market share perspective we have provided, which is a value-based market share at 27%, we are in the process of turning that value-based market share into a volume-based share calculation, which is a bit difficult, given some of the dosing dynamics associated with ESAs. But it's probably fair to say that our current volume penetration is much, much lower than 27%, which just speaks to the significant upside potential that roxadustat continues to have in the China market. And we think it's also, as Enrique said in his prepared comments, it's a really nice read-through to the other markets when we are able to launch in the U.S. and Europe.

There are no further questions at this time. I would like to turn the call back to Enrique. Please go ahead, sir.

Very good. Thank you Erica. We very much 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 very much.

This concludes today's conference call. Thank you all for joining. You may now disconnect.