Kyntra Bio, Inc. (KYNB) Q2 2020 Earnings Report, Transcript and Summary

Good afternoon, ladies and gentlemen, and welcome to the FibroGen Second Quarter 2020 Financial Results. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to hand the conference over to your host Michael Tung. Please go ahead.

Thank you, Ashley, and good afternoon, everyone. 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; Thane Wettig, our Chief Commercial Officer; Pat Cotroneo, our Chief Financial Officer; Dr. Peony Yu, our Chief Medical 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 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; the 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. For a more complete description of these and other material risks can be found in FibroGen's filings with the SEC, including its most recent Form 10-K and Form 10-Q. FibroGen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. The press release reporting our financial results and business update and a webcast of today's conference call can be found on the Investors section of FibroGen's website at www.fibrogen.com. And with that I would like to turn the call over to Enrique Conterno, our CEO. Enrique?

Thank you, Mike. Good afternoon, everyone, and welcome to our second quarter 2020 earnings call. Despite the challenges presented by the COVID-19 pandemic, on behalf of FibroGen, I'd like to reassure patients, health care providers, investigators and stakeholders of our continued commitment to bring our potential first-in-class medicines to patients suffering from chronic and life-threatening conditions. We continue to monitor the situation closely. To our employees and our patients and to the health care providers, regulators and countless others who interact with FibroGen, please know our thoughts are you and your families. I want take a moment to welcome both Dr. Aoife Brennan, and Dr. Ben Cravatt to our Board of Directors at this exciting point in Fibrogen's history. Aoife's experience in rare diseases and clinical development and Ben's world-class expertise in biology and chemistry will provide invaluable perspective to our Board. With today's earnings call, we are implementing a new format with a goal to improving communications with the investment community and other stakeholders. I will begin by providing a high-level summary of the most important accomplishments and developments from the second quarter. Pat Cotroneo, our CFO, will then review the financials. After which, we will open up the call to your questions. Today's updates will include our China results, U.S. regulatory review and our clinical trials. We hope this new format will result in more time for us to have a constructive dialogue. So let us get started with our strong China results. With a return to a new normal business environment in China, we are pleased to report net sales of roxadustat of $15.7 million for the second quarter. This represents an increase from the $5 million in China net sales reported the first quarter. We are most encouraged by the trajectory of the launch, which is being driven by both an expansion in hospital listings and continued adoption. Hospital listings continue to be a key focus of our launch efforts. Notably, as of the end of the second quarter, roxadustat was listed as hospitals representing over 45% of the CKD anemia market opportunity in China. This is in comparison to the over 30% reported at the end of the first quarter. We're especially pleased with the penetration at top-tier Class IIIA institutions, which are generally the larger ones and the hospitals were key opinion leaders and early adopters practice. We continue to see broad roxadustat utilization across different patient populations, including in the hemodialysis, peritoneal dialysis and non-dialysis populations. Utilization across these different patient populations bodes well for long-term success and provides important learnings as we prepare to launch roxadustat in the U.S. and other countries. Finally, we recently amended our China collaboration with AstraZeneca. The new agreement more optimally aligns both FibroGen and AstraZeneca to maximize the economic value of the roxadustat franchise and will result in improved and more predictable economics and profitability for FibroGen. We look forward to keeping you updated as we advanced our long-term goal of making roxadustat the standard of care in treating China's CKD anemia patients. Let us turn now to the U.S. regulatory review and commercial preparation for roxadustat. We had our mid-cycle review with the FDA in June and continue to expect an FDA decision on the roxadustat NDA by the PDUFA date of December 20, 2020. The FDA has indicated that an advisory committee meeting is not planned at this time. Overall, we are pleased with the cadence of an engagement with the FDA. While future interaction with the FDA are planned, given the proximity of label discussions, we will no longer be commenting on those interactions until the PDUFA date. On the commercial front, we appointed Thane Wettig to the newly created position of Chief Commercial Officer, where he will lead FibroGen's commercialization efforts. Thane brings more than 30 years of global biopharmaceutical leadership and experience, and we welcome his leadership in this area. Thane is working closely with our partners, AstraZeneca and Astellas, to ensure ruxadustat will reach as many CKD anemia patients as possible on a worldwide basis. We continue to work closely with AstraZeneca regarding U.S. launch preparation activities. Within the next few months, we expect to have submitted up to 10 manuscripts covering the Phase III data, both individual trial and pooled data sets. At the upcoming American Society of Nephrology Congress in October, we expect to present a meaningful number of abstracts on roxadustat and HIF-PHI science. We continue to engage with CMS on the Transitional Drug Add-on Payment Adjustment, or TDAPA. Finally, disease awareness activities imperative to reframing the primary defect of CKD anemia from one of EPO and iron deficiency to an oxygen sensing deficit are underway in the U.S. In Europe, the filing for roxadustat for the treatment of anemia in adult patients with chronic kidney disease was accepted by the European Medicines Agency in May. Our partner, Astellas, expects a European approval decision mid-2021. Moving now to our pipeline, starting with newly initiated clinical trials. In June, we initiated two separate trials studying pamrevlumab in patients hospitalized with COVID-19. In the U.S., we initiated a Phase II study investigating the efficacy and safety of pamrevlumab in hospitalized patients with acute coronavirus infection. This multicenter trial will enroll approximately 130 patients with COVID-19 and will assess patient time to and on ventilatory support. In Italy, a Phase II/III investigator-initiated trial investigating the efficacy and safety of pamrevlumab in approximately 68 patients hospitalized with COVID-19 was started. The primary objective of this study is to assess the effect of pamrevlumab on blood oxygenation in patients with COVID-19 infection in the acute and post-acute settings. The majority of patients suffering from severe forms of COVID-19 have bilateral interstitial pneumonia causing reduction in oxygenation and severe respiratory failure. The administration of our anti-CTGF antibody, pamrevlumab, could protect the lung from the immediate consequences of the infection presented as acute respiratory distress syndrome. Now moving to an update of our ongoing clinical trials, the COVID-19 pandemic continues to present challenges to the conduct of clinical trials across our industry. The most effective of our trial continues to be pamrevlumab's ZEPHYRUS IPF trial in which we temporarily paused enrollment for two months due to the vulnerability of this patient with severely compromised lung function. We have reopened ZEPHYRUS for enrollment and the remainders of our studies in locally advanced and resectable pancreatic cancer, myelodysplastic syndrome and chemotherapy-induced anemia continue enrollment, albeit at slower rates. We expect to initiate LELANTOS, a Phase III trial of pamrevlumab in patients with non-ambulatory Duchenne muscular dystrophy this quarter, and we plan to publish updated two-year data from a recently completed Phase II DMD before year end. We remain focused on accelerating enrollment of all of our ongoing clinical trials while ensuring patient safety. I will now turn the call over to Pat Cotroneo, our CFO, to review the financials. Pat?

Thank you, Enrique. As announced today, total revenue for the second quarter of 2020 was $42.9 million as compared to $191.6 million for the second quarter of 2019. The current quarter revenue consists of net product revenues of $15.7 million for roxadustat sales in China, $19 million in development revenue and $8.2 million of API sales in Japan. For the same period, operating costs and expenses were $128 million and net loss was $85.3 million or $0.95 per basic and diluted share as compared to operating costs and expenses of $78.7 million and a net income of $116 million or $1.34 per basic and $1.26 per diluted share for the second quarter last year. Included in operating costs and expenses for the quarter ended June 30,2020, was an aggregate noncash portion totaling $23.6 million, of which $17.6 million was a result of stock-based compensation expense as compared to an aggregate noncash portion of $21.9 million, of which $17.6 million was a result of stock-based compensation expense for the same period in the prior year. At June 30, FibroGen had $716 million in cash, cash equivalents, restricted time deposits, investments and receivables. During the second quarter of 2020, we received $50 million for a milestone payment from AstraZeneca relating to the FDA’s acceptance of our U.S. NDA filing and $130 million of milestone payments from Astellas in connection with the EU MAA filing. Both of these milestones were recognized as revenue in the prior year when achievement became probable. Based on these milestone payments and our latest forecast data, we continue to estimate our 2020 ending balance of cash, cash equivalents, restricted time deposits, investments and receivables to be in the range of $720 million to $730 million, assuming U.S. NDA approval in Q4 2020. Looking ahead, we have a total of $245 million in anticipated milestones expected over the next 12 months for anticipated U.S. and EU approvals and first commercial sale in the U.S. At this point in time, we have no changes in our expectations in any of the anticipated milestones over the next 12 months. Thank you. And I would now like to turn the call back over to Enrique.

Very good. Thank you, Pat. And in summary, FibroGen is well positioned. Our business continuity plans are in effect. And while we’re seeing some impact to our operations resulting from COVID-19, we have the capabilities and resources to navigate through these uncertain times and achieve our stated goals. As roxadustat sales ramp up in China, our financial position is strong with approximately $716 million in cash at the end of the second quarter. The EMA’s acceptance of the roxadustat filing for treatment of anemia in adult patients with CKD triggered milestone payments of $130 million from Astellas to FibroGen. In addition, we have a total of $245 million in anticipated approval and first commercial sale milestones expected over the next 12 months. We received full partner reimbursement for all developments and commercialization of roxadustat in all geographies, except China, where we shared these expenses 50-50 with AstraZeneca. Based on our current forecasts, we are reiterating our estimated 2020 ending cash to be in the range of $720 million to $730 million, and we’re well financed for years to come. Ashley, if you could now open the lines for questions.

[Operator Instructions] Your first question comes from Geoffrey Porges with SVB Leerink. Your line is now open.

Thank you very much. And congratulations on the positive regulatory interaction. I have to ask a little bit about that. So perhaps, Enrique, you could give us a sense of how important to the commercial opportunity is whether or not you get a black box warning for CV risk. And then secondly, could you give us a little bit more color how the China agreement with AstraZeneca has changed? And particularly how it may have influenced your flexibility with respect to the ownership and integration of that business unit? Thanks very much. Appreciate the question.

Very good, Geoff. Thank you for your questions. Let me try to answer first your – the second part of your question related to the update in our China agreement with AstraZeneca. Clearly, we believe that this updated agreement best aligns I think both organizations to maximize the economic value of roxadustat. Importantly, this agreement allows us to have both more predictable but also improved economics for FibroGen. So we are excited about having been able to update this agreement and given the significant opportunity that we see with roxadustat that has a very good chance of becoming a blockbuster product in China. I think you were referring how this impacts other future plans. I think it’s – as I mentioned in the past, we’re not prepared to comment on that. But I think, if anything, having this agreement I think gives us more flexibility to do anything because I think we have a great foundation for our business in roxadustat. As it relates to a boxed warning, as I mentioned, we’re not planning to make comments when it comes to labeling going forward. But clearly, we view that roxadustat will be successful – I think I’ve mentioned this to you and others in the past, very successful regardless. Clearly, we need to look at the entire label. And when we look at the label for roxadustat, including a potential boxed warning, it’s going to be what does the labor in totality says and our ability to fully commercialize roxadustat, given all the benefit that it can provide. We continue to view that our data shows a very positive benefit risk profile for the product.

Great, thank you.

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

Hi there, good afternoon, and thanks for the questions. Congrats on the progress. Two questions for me. Enrique, I know you can’t comment specifically on FDA discussions. So I guess my question is more about what sort of the key takeaways are from your mid-cycle review meeting? And what are the key shall I say, gating steps for you as you get to the end of the year on the review? Second question is on China. Maybe you can make a comment or Chris could make a comment. Obviously, a pretty strong number in the second quarter. Maybe you could just shed a little more light on that. Is there anything particularly surprising that could be a read-through to the United States, et cetera, et cetera? The United States has a different reimbursement model, of course. So maybe you could talk to how much can we read-through into things. Thanks so much.

Very good. Thank you, Michael. Basically on the mid-cycle review, I think, clearly, it is – the mid-cycle review is an overall update of our submission. But when it comes to news, as we’ve shared, the FDA indicated to us that there’s no outcome that is planned at this stage. Clearly, you are asking about other types of interaction with the FDA going forward. I think it should be no surprise, but clearly, labeling discussions are critical, and those will be starting soon. And of course, we need preapproval inspections and so forth. But our engagement and our interaction with the FDA was positive. So we feel good about the progress that we are making. As it relates to China, I’m going to allow Chris to give us a little more detail and color on our strong results there.

Thank you, Enrique. Hello, Michael, so obviously, we’re very pleased with the results of the second quarter. It’s a big jump from Q1. That is primarily due to increases in two things: hospital listings and market adoption. We looked at our channel sales. There’s nothing spectacular about it. We believe it’s very consistent with the market. So in terms of reading through to the future of China and the U.S., I think it just tells you the strength of the roxadustat as a drug that delivers significant benefits and efficacy to multiple patient populations, profile. And, in particular, in peritoneal dialysis and non-dialysis, the oral convenience is a very attractive feature over ESA.

Yes, I think…

So to be clear, do you see good adoption in non-dialysis? I guess that was the sort of the real word of the question, too.

We have been very encouraged by the adoption in non-dialysis. We had anticipated that the launch market would be in dialysis, but the non-dialysis adoption has pleased us in a very positive way.

Yes. I think, Michael, clearly, I think what you’re sensing from us is quite a bit of optimism. I think probably you sensed it during the last earnings call, but now we have some good sales results to show the progress that we’re making. We are very pleased with the adoption of roxadustat in different patient populations. And you spoke about what are the implications for this to other countries? Of course, different countries have, including the U.S., different reimbursement schemes and – but when it comes to physician adoption, I think we see a lot of read-through in terms of the benefits the health care professionals are seeing with roxadustat.

Perfect. Thank you so much.

Your next question comes from Annabel Samimy with Stifel. Your line is now open.

Hi, thanks for taking my questions. This is Edwin on for Annabel. First maybe to follow Mike’s question on China. We learned that in the first half, there are about 40,000 patients treated with roxa. How many of them are DD or NDD patient, if you could split them up? And how many new patients added in the second quarter? What is the launch curve do you project in the coming quarters? And then I have a follow-up, if I may.

Yes. I’m going to ask Chris to answer that question in China. As you know, we don’t provide forward-looking forecast when it comes to roxadustat at this time. But maybe, Chris, you can provide some additional color around China.

Absolutely. Hello, Edwin. At this point in time, in terms of these segments, we believe two-thirds of the patients currently using roxadustat are dialysis patients, which is obviously hemodialysis and peritoneal dialysis with the other third, which is a very strong third, being from non-dialysis. At this point in time, the 40,000 number is an estimate based on sales and assumptions about pricing, compliance and DOT. The increase has been from about 15,000 at the end of the first quarter to 40,000 now. It’s a very nice trajectory. Obviously, looking into the second half of 2020, there will be changes in duration of treatment because many hospitals are just getting listed and reimbursement has just been implemented by the end of Q1. So at this point in time, it will be very difficult for us to project, but we continue to be very optimistic about the upward trajectory we’re seeing in China.

Great. Thanks for the color. And two regulatory questions. Do you think the chance for possible Adcom is significantly reduced at this point? And secondly, on CMS negotiation, have you got any preliminary agreement with CMS on the bundling issue? When do we expect any clarity on the progress with CMS, before or after roxa approval? Thanks.

Very good. Let me try to provide maybe a reinforcement on the question related to the Adcom. So clearly, with the indication of the FDA that no Adcom is planned at this time, I think the likelihood of having an Adcom has decreased significantly. It doesn’t mean that an Adcom could not be called or it’s – but it is – the FDA is not planning for one at this stage based on the engagement that we had with them at the mid-cycle review. In terms of CMS discussions, clearly, we have those discussions, but there’s no such a thing as an agreement other than we will have to submit. Once we get approval, we will have to submit to CMS for the inclusion on TDAPA. And that can be done as soon as we get approval and then FDA – the CMS will basically process that as quickly as possible. And we are – we’ve done all the homework to ensure that we are ready and that we are hopeful that we can get expedited approval. I’m going to ask maybe Thane Wettig, our chief – our newly appointed Chief Commercial Officer, maybe to make some additional comments. Thane?

Yes. Thanks, Enrique. I think just to add to what Enrique said, the most important date for us is approval. And once we get approval, AstraZeneca and FibroGen will file for a HCPCS code, and then that starts the TDAPA review process. Now CMS’ goal with TDAPA is to make the product available as quickly to their beneficiaries as they possibly can. And they state in their regs that their goal is to make TDAPA available within 90 – or within the quarter within 90 days. And so that’s the expectation that we have. And rest assured that we and AstraZeneca are doing everything in our power to assure the earliest possible availability of TDAPA for roxadustat.

Great. Thanks a lot.

Your next question comes from Joel Beatty with Citi. Your line is open.

Hi. Thanks for taking the questions. I guess, following up to the last question on TDAPA and the 90-day window, can you help provide some context of that kind of the gate-limiting factor to launching in dialysis centers or are there other things that need to take place, such as negotiations with the dialysis centers in order to start selling product there?

Yes. I’m going to – great question. I’m going to have Thane comment, but you really need both, right? You really need TDAPA, and you really need to have the discussion with the dialysis organizations.

Yes. That’s exactly right. And in addition, for the dialysis-dependent patient population, our estimate is that about two-thirds of those patients will – are currently being treated through the ESRD Prospective Payment System. And so there’s about third of the patients that also go through Medicare Advantage as well as commercial. And so we’ll be working actively with the priority payers. Between now and not just when product is available, but between now and even launched, having those conversations to set the stage for availability of roxadustat not only through the TDAPA designation but also through the private sector as well.

Great. And then maybe just one follow-up to that. How important are agreements such as the one that Akebia has with Vifor to the dialysis market? Is that something that would be an impediment to your launch? Or is that the type of agreement that you may be exploring as well?

No. We – honestly, we do not view that we have a restriction or any type of limitation for us to be able to have agreement with any of the dialysis organizations. So at this point in time, we feel we’re in a very good position.

Thank you.

Your next question comes from Jason Gerberry with Bank of America. Your line is open. Yes. Jason Gerberry with Bank of America. Your line is now open.

Sorry, I was on mute. Thanks for taking my questions guys. Enrique, just to follow-up on that last comment. What do you think the value is of having a contractual arrangement with the dialysis organization for a company like Akebia if you don’t view it as an impediment to your ability to garner uptake in the market? And then my other question is, can you talk a little bit about how you see the China hospital listing progressing in the second half? Just kind of curious how you’re seeing that progression going versus the benefit we saw in 1Q from 2Q. Thanks.

Yes. I think on – thank you for your question. I think on the first question is really – I’m not sure this is a question for FibroGen. It’s probably a question for Akebia, given they’re the one that pursued that agreement. When it comes to hospital listings, as we mentioned, we went from basically over 30% to over 45%. So we were at over 30% at the end of Q1. We are now over 45% at the end of Q2. If we were to benchmark some of the blockbuster products in China, innovative blockbuster products in China, I think you will see that this level of penetration and when it comes to the overall opportunity in China to be at 45% of that opportunity, I think, is very significant milestone and achievement, basically at the second quarter post launch. So we feel extremely good. We expect to continue to make progress, but we do not provide formal forecast whether it comes to either revenue or listing for future quarters at this stage.

Okay, great. Thank you.

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

Hi, good afternoon. And thanks for taking my question. Just a couple. The first one on roxa in China. I know it’s in the early days, but for dialysis patient population, do you see most of the prescriptions going to ESA failure patients or do you see adoptions across the board in that population?

Let me once again call on Chris to give us some additional color on some of these dialysis-dependent patients. Are they ESA failures or treatment naive or what can you tell us?

So we are seeing adoption across all those patient segments. To give you a little bit of color to first look at the hemodialysis population. We are getting inflamed hyporesponses and iron-deficient patients in hemodialysis. We have not seen a very large conversion for ESA-treated patients who are maintained properly and have performed well on ESAs. On peritoneal dialysis, however, because of the oral administration, we are seeing a lot of conversion patients as well as new patients, regardless of how they have responded to ESAs in the past. So I think in terms of differentiating the product profile, it's a very, very strong value proposition to hemodialysis and peritoneal dialysis, and that is the same in the case of non-dialysis as well.

Chris, maybe you can also comment about China has a uniquely large peritoneal dialysis patient population. Maybe you can comment about that.

Absolutely. So in terms of percentage right now, the peritoneal dialysis population is around 14% to 15%. The government is trying to increase it, but it's been stable at around that percentage. China currently has 800,000 dialysis patients, expected to exceed 1 million in the next couple of years. So if you just take 15% of 800,000 patients, there are currently over 100,000 peritoneal dialysis population patients in China. We've seen very, very strong adoption in both the installed base and new patients. And the initiation rate into PD is actually higher than hemodialysis. Interestingly, COVID has played a factor in it, because many new patients prefer to not be going to a hemodialysis center three times a week. Unexpected trend, of course, but very, very positive for adoption of roxadustat in China.

Thank you, Chris.

Your next question comes from Yaron Werber with Cowen. Your line is now open.

Hi guys. This is Brendan on for Yaron. Thanks very much for taking the question. Congrats on the progress. Just a couple of quick ones from us. First, I just really wanted to ask kind of about some of the top level kind of key learnings you've picked up from the China launch so far and how you're thinking about applying some of these to the U.S. launch, particularly in light of what's going on here and all the challenges, just kind of most important considerations you're bearing in mind. And then I also wanted to just quickly ask about the MDS and CIA trials. If you can give us any more granularity on where you're at in enrollment, respective time lines and when we might get some data from either of those? Thanks very much.

Yes. Let me try to address your first question. I'm going to ask Peony to discuss both the MDS and CIA trials. When it comes to learnings from China, as you can imagine, it's probably not in our best interest to be discussing those, given the competitive environment that we have in other markets. But I think it's fair to say, I think that one of the things that we've learned is that we have the ability to be able to grow roxadustat in different patient populations. I think this is important because it gives you a number of different ways to grow. And given when we think about hemodialysis, peritoneal dialysis, non-dialysis patients, it's just a broad spectrum of patients that can give us huge legs for growth into the future. So very excited about what that could do for us in the U.S. for us to think, yes, short-term, when it comes to the launch, but also longer-term in terms of what this product could become. And I'm going to ask Peony to give us an update now on both MDS and CIA.

Thank you. Both the MDS and CIA trial are going well. The COVID inevitably has had some impact on some of the study sites. And – but we were able to work with our investigators in ensuring patient safety while optimizing patient enrollment. At the same time, we have instituted remote monitoring process and remote data review to ensure data integrity. And we are not seeing increase in subject visits or during the pandemic because our investigators are managing the study so well. And we anticipate that with all the – some of these adaptations and continued strong effort that these two studies will continue to be able to be executed successfully.

We feel good about our enrollment with both of those trials. Despite the impact, I think the team has appropriately adapted to ensure that we can enroll very well.

Okay. Great. Thanks very much.

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

Hi. Thank you. Good afternoon, everyone and thanks for taking our questions. A few from me, please. Enrique, maybe could you comment on how you see the role of roxa in the home dialysis setting here in the U.S.? Is that a commercial priority for you? And how are you thinking about potentially marketing to that market? Second, your partner presented updated NDD data from the DOLOMITES study at a recent medical meeting. I was just wondering if you could also maybe comment on your updated thoughts with regard to the MACE and MACE+ endpoints and how that adds to the totality of the existing CV data? And then third, given the uptick you've had in China so far, Enrique, how do you think about potentially unlocking shareholder value there from that business and either monetizing it or thinking about it potentially as a separate entity? Thank you.

Very good. Let me try to have different people answer your – the opportunities. Maybe on roxadustat and the opportunity in home dialysis, I'm going to ask Thane to maybe provide a few comments; on DOLOMITES, I'll ask Peony to comment; and then I'll answer the question around China and unlocking shareholder value. Thane?

Sure. As it relates to home dialysis, it's clearly not the priority segment as the LDO or the MDO or the other dialysis centers are the hospital-based dialysis centers. Same thing with the NDD population. We're taking a look at it right now to determine what level of presence we need in order to take advantage of that. But I think it's a different dynamic than it is in China.

Yes. We have clearly a very favorable product profile, but the relative size of the opportunity is smaller here than in China. Peony on NDD and DOLOMITES?

Yes. So on MDD DOLOMITES, we believe that this active control study of roxadustat being compared against darbepoetin provides further confidence on roxadustat. In that, we demonstrate efficacy in comparison to the active comparator. And importantly, the hazard ratio of MACE is 0.8. And so this is incremental confidence building on top of the non-dialysis pool analysis.

Keep in mind, Paul, as we've shared before, I think there is agreement with the FDA on the studies that are the pivotal studies to be pooled for the MACE analysis in the U.S., DOLOMITES was not part of that. But of course, you see what the results are, and they are I think we can say encouraging. When it comes to your question on unlocking value in China, the best way for us to ensure that we can lock as much value in China as possible is to make roxadustat as large as possible as we can. So for us, I think having a great launch I think is critical. Keep in mind that when we look at – I'm going to mention this again, when we look at benchmarks of products that are innovative blockbusters in China, and when we look at either their revenue uptake or listing uptake, roxadustat studies comparing extremely well. So clearly, I think this is priority one. As I've mentioned, I think we are going to be looking at all opportunities for us to ensure that our China business is fully appreciated by our shareholders, given the huge value that we believe that we have there.

We have reached the end of the Q&A session. I will now turn the call over to Enrique Conterno for closing remarks.

Very good. I want to thank everyone for joining us on this earnings call. And once again, all of our collaborators, whether they are patients or health care professionals, investigators, regulators that are allowing us to progress our agenda. But in particular, I want to thank the entire FibroGen team for the commitment to the type of progress that we are seeing today. So thank you very much, everyone.

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