FibroGen Inc (FGEN) Q1 2021 Earnings Call Transcript

Image source: The Motley Fool.

FibroGen Inc (FGEN -0.87%)
Q1 2021 Earnings Call
May 10, 2021, 5:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day, and welcome. Thank you for standing by. Welcome to the FibroGen First Quarter 2021 Financial Results Conference Call. [Operator Instructions] After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]

I would now like to hand the conference over to your speaker for today, Mr. Michael Tung. Please go ahead.

Michael Tung -- Vice President of Corporate Strategy and Investor Relations

All right. Thank you, Erica, and good afternoon, everyone and welcome to FibroGen's conference call for fiscal 2021 first quarter. I'm Michael Tung, Vice President of Corporate Strategy and Investor Relations at FibroGen. Joining me on today's call are Enrique Conterno, 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'd 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; the 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 uncertainties 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 Form 8-K with the Securities and Exchange Commission. All statements are made on 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?

Enrique Conterno -- Chief Executive Officer

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 the most important accomplishments and developments in recent months. Pat Cotroneo, our CFO, will 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 Issues] 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 continued strong performance in China, and our clinical trial programs. Let us get started with the roxadustat US New Drug Application or NDA review. In March, we announced that the FDA had 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 3 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 epotein alpha 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 epotein alpha 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 got reached out the 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'll 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 3 program. FibroGen and AstraZeneca are committed to working together with the FDA to bring roxadustat to patient with anemia CKD in the US. 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 US, 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 with payors who cover non-dialysis patients.

We have submitted manuscripts covering the CKD anemia Phase 3 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 3 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 the 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 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, interesting thing is the inclusion of roxadustat on the NRDL that 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 along with 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 populations. 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 US, 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 2 chemotherapy-induced anemia or CIA trial. In ASPEN and DENALI, our two roxadustat Phase 3b studies in CKD anemia patients conducted with US dialysis organizations, many patients have transitioned now into the extension phase. We expect to present top line data at the future medical meeting.

Moving now to pamrevlumab. In March, we announced the initiation of LELANTOS-2, our Phase 3 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 US 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 the potential treatment options for DMD patients.

I will turn now the call over to our CFO, Pat Cotroneo, for the financial updates. Pat?

Pat Cotroneo -- Chief Financial Officer

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's 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 US 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 the 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 US and EU approvals and first commercial sale in the US. 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 US and EU roxadustat approval in 2021.

Thank you. And now, I would now like to turn the call back over to Enrique.

Enrique Conterno -- Chief Executive Officer

In closing, this is an exciting time for FibroGen. Roxadustat continues to perform very well in China and is under regulatory review in the US, 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 3 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 the 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?

Questions and Answers:

Operator

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

Annabel Samimy -- Stifel -- Analyst

Hi. Thanks for taking my question. I'm not sure if I missed the initial comments, but I was wondering if you could tell us during the preparations for the AdCom, have you conducted analysis of any of the additional clinical benefits that were published or presented or claimed like reduced RBC transfusion, efficacy regarding inflammatory status on HIF responders or better iron utilization? And can you feel comfortable that the data that you present 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.

Enrique Conterno -- Chief Executive Officer

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.

Mark Eisner -- Chief Medical Officer

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

Enrique Conterno -- Chief Executive Officer

Very good. Clearly, I think when it comes to China, I think the results in China, I think I would call nothing short of impressive and quite frankly gives us a lot of confidence for how roxadustat is becoming a primary choice when it comes to treating anemia CKD patients in China across the contingent of both DD and NDD. There are a number of learnings that we are capturing from China. One of them I think I have mentioned in the past was we've seen a faster-than-expected uptake in particular in NDD, in the NDD segment.

And what we basically see is basically also excellent feedback, because it is -- 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're seeing continued growth quarter-on-quarter. That basically reflects much of the overall benefit risk profile of roxadustat that we've 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 read-through of that to other markets.

Annabel Samimy -- Stifel -- Analyst

Right. Thank you.

Operator

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

Michael Yee -- Jefferies -- Analyst

Hi. Good afternoon and thanks for the update. We had two questions. The first was to the extent you can talk about maybe topics or relevant areas of interest that you think will be discussed or could be a focus for the panel, that would be great. Since it sounded like you 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, and I know that it is being reviewed in terms of an AdCom from the cardiovascular and renal group, is that a separate group that you've had dialogue with or how does that play into things in terms of ongoing discussions? Thank you.

Enrique Conterno -- Chief Executive Officer

Yes. I'm going to have Mark Eisner try to answer both of those questions and I'll complement this after this. Mark?

Mark Eisner -- Chief Medical Officer

Yeah. So thanks for the question. So yeah, we have been having collaborative 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 fulsome discussion at the 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 further explaining the safety and the efficacy of the medicine for NDD and DD populations 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 cardio-renal drug Advisory Committee, which it is. And yes, we've had conversations both with the office -- at the office level with the cardio-renal -- it's actually OCHEN that includes cardio and renal and also with the benign hematology division. So we've got discussions at all those levels of FDA, including now the various stakeholders for both of these areas.

Enrique Conterno -- Chief Executive Officer

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

Michael Yee -- Jefferies -- Analyst

The reason I ask is because this is -- supposedly will have renal or nephrology experts on there and do 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?

Mark Eisner -- Chief Medical Officer

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 yeah, so I think it's going to be really important to have that nephrology input.

Michael Yee -- Jefferies -- Analyst

Got it. Thank you.

Operator

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

Edwin Zhang -- H.C. Wainwright -- Analyst

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 US dialysis organizations? And then I have a follow-up.

Mark Eisner -- Chief Medical Officer

Sure. So the ASPEN and DENALI, 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 is 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.

Edwin Zhang -- H.C. Wainwright -- Analyst

Okay. My last question on pamrevlumab on DMD. Are we going to expect a publication of the Phase 2 study, including the two-year data? And what's your current thinking on the market opportunity of pamrevlumab in DMD? Thanks.

Enrique Conterno -- Chief Executive Officer

Yeah. We'll have Mark answer the question on pamrevlumab on Duchenne muscular dystrophy and questions, in particular, around the two-year data on publishing that data.

Mark Eisner -- Chief Medical Officer

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're working on that actively and we do think that's important to show how the benefits continue to be between year one and year two.

Enrique Conterno -- Chief Executive Officer

And I think you're 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 are significant opportunities. The IPF opportunity when we look at from a -- 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 are -- 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 a specific time in the near future.

Edwin Zhang -- H.C. Wainwright -- Analyst

Thank you.

Operator

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

Jason Gerberry -- Bank of America -- Analyst

Hi, 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 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 that may offer some of those financial benefits? Just thinking about the longevity of the dialysis launch. Thanks.

Enrique Conterno -- Chief Executive Officer

Yeah. Thank you. I think on your first question, we do not comment on either ongoing or potential litigation. That's -- as far as your question about HIFs and how would second or third HIF, whatever 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've 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 the 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 there is going to work well. Keep in mind that our -- at the end of day we have to look at also the clinical data and how does that product basically compare for us. So there are number of variables. And I don't believe this is -- that we should be thinking, as we've 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.

Jason Gerberry -- Bank of America -- Analyst

Got it. Thanks.

Operator

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

Geoffrey Porges -- SVB Leerink -- Analyst

Thank you very much for taking the questions. First one, I'll 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 2 and Phase 3 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.

Enrique Conterno -- Chief Executive Officer

Yeah. Thank you, Geoff, for your questions. Let me first state that when it comes to our interaction with the FDA, I think we're not really providing any detail when it comes to our interactions. Clearly, just, in general, I think the -- we expect that the FDA will be looking at the overall evidence what we -- including what the primary analysis says and also on a number of sensitivities around some of those analyses. So far, we feel good about our discussions with the FDA and 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're going to need to see when it comes to CIA what's -- based on the Phase 2 results, what is the dose and so forth, and also what is that we're basically seeing. So I expect that CIA or 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, the medicine is offering in the different populations. And while that is always the goal, we all know that that is the challenge in particular, is the challenge in the US, how to effectively do that. So at this point in time, we're 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're appropriately receiving the value for what roxadustat is offering the different patient populations.

Finally, you asked a question about the relative -- FibroGen reported revenue relative to the overall sales, the net sales to distributors between the joint distribution entity of 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 need to -- 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 an incredible performance and is really valued I think in terms of what it's offering patients in China.

Geoffrey Porges -- SVB Leerink -- Analyst

Great. Thanks very much, Enrique.

Operator

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

Brendan Smith -- Cowen and Company -- Analyst

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.

Enrique Conterno -- Chief Executive Officer

Yeah. 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 January and February. I don't think that's the case. For roxadustat, clearly, we're basically seeing an increased share and we're seeing an 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've 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'm going to have Mark Eisner answer for you.

Mark Eisner -- Chief Medical Officer

Yeah, 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 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 top line data from the overall study to be available, that I think we've been consistent that should be by end of year at medical meeting.

Brendan Smith -- Cowen and Company -- Analyst

All right. Thanks very much, guys.

Operator

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

Difei Yang -- Mizuho Securities -- Analyst

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.

Enrique Conterno -- Chief Executive Officer

Yeah, let me just very quickly on the DENALI and ASPEN. We're not commenting on who are we doing those studies with, but as we said, it's clearly we're doing this large dialysis organizations. And as far as the AdCom, of course, FibroGen is the sponsor so we're the sponsor of the NDA and maybe, Mark, you can provide some additional comments on the relevance of Zeneca.

Mark Eisner -- Chief Medical Officer

Yeah, I would describe it as a highly collaborative effort between FibroGen and AstraZeneca. We've essentially formed a joint working team to prepare for the Advisory Committee, to prepare the presentations and they're ready for the Q&A. So it's a highly collaborative process between both companies.

Difei Yang -- Mizuho Securities -- Analyst

Thank you.

Operator

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

Lisa Yang -- Goldman Sachs -- Analyst

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're thinking about any updating timing in this program, regulatory and potentially commercial as well? Thank you.

Enrique Conterno -- Chief Executive Officer

Yeah, maybe I will comment on -- I'll 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 to 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've 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 level program. So we are excited about those designations.

I think the designations generally basically allow for basically more interaction with the 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?

Mark Eisner -- Chief Medical Officer

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.

Lisa Yang -- Goldman Sachs -- Analyst

Great.

Operator

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

Andy Hsieh -- William Blair -- Analyst

Oh, 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'm just curious as you kind of reach going from about 74% to 80% to 90% -- to 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'm just wondering what the FibroGen China team is thinking about in terms of kind of preparing for that? Thank you.

Enrique Conterno -- Chief Executive Officer

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

Christine L. Chung -- Senior Vice President, China Operations

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 it. 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, 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 state 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 are dialing this drug.

We remain confident in the outcome of price negotiations. To be clear, the price only goes in one way, 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 this 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're working very closely with market access and 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.

Thane Wettig -- Chief Commercial Officer

Hey, Chris, this is Thane. If I could just maybe piggyback on to your answer on the China trajectory to answer -- to provide some more color on Andy's first question. This is really the first time we've 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 in this we've 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've 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 US and Europe.

Operator

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

Enrique Conterno -- Chief Executive Officer

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.

Operator

[Operator Closing Remarks]

Duration: 54 minutes

Call participants:

Michael Tung -- Vice President of Corporate Strategy and Investor Relations

Enrique Conterno -- Chief Executive Officer

Pat Cotroneo -- Chief Financial Officer

Mark Eisner -- Chief Medical Officer

Christine L. Chung -- Senior Vice President, China Operations

Thane Wettig -- Chief Commercial Officer

Annabel Samimy -- Stifel -- Analyst

Michael Yee -- Jefferies -- Analyst

Edwin Zhang -- H.C. Wainwright -- Analyst

Jason Gerberry -- Bank of America -- Analyst

Geoffrey Porges -- SVB Leerink -- Analyst

Brendan Smith -- Cowen and Company -- Analyst

Difei Yang -- Mizuho Securities -- Analyst

Lisa Yang -- Goldman Sachs -- Analyst

Andy Hsieh -- William Blair -- Analyst

More FGEN analysis

All earnings call transcripts