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spk04: Ladies and gentlemen, thank you for standing by and welcome to ViberGen's first quarter 2022 earnings conference call. At this time, all participants' lines are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your first speaker for today, Michael Tong. Thank you. Please go ahead, sir.
spk06: Thank you, RJ, and good afternoon, everyone. I'm Michael Tong, Vice President of Corporate Strategy and Investor Relations at FibreGen. Joining me on today's call are Rico Conterno, our Chief Executive Officer, Dr. Mark Eisner, our Chief Medical Officer, Juan Graham, our Chief Financial Officer, Dr. John Hunter, our Chief Scientific Officer, Feng Wedig, our Chief Commercial Officer, and Chris Chung, our Senior Vice President of China Operations. The format for today's call includes prepared remarks from Enrique and Juan, 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. A more complete description of these and other material risks can be found in Fibersen's filings with the SEC, including our most recent 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 investor section of Fibrogen's website at www.fibrogen.com. With that, I would like to turn the call over to Enrique Quintero, our CEO. Enrique?
spk02: Thank you, Mike, and good afternoon, everyone, and welcome to our first quarter of 2022 Earnings Call. On today's call, I will provide a high-level summary of the most important accomplishments and developments in the first quarter of 2022. Juan Graham, our CFO, will then review the financials, after which we will open the call for your questions. Starting with slide three, Sovereign is positioned to create significant value for patients and shareholders by executing on our three areas of focus. Number one, accelerating the development of pembrelumab in three indications with significant unmet medical needs. Idiopathic pulmonary fibrosis, or IPF, locally advanced and resectable pancreatic cancer, or LAPC, and Duchenne muscular dystrophy, or DMD. Number two, ensuring commercial success of Roxadustat in patients with chronic kidney disease outside the U.S., while continuing to explore a path forward in the U.S. And number three, increasing our research productivity to advance novel programs that leverage internal expertise and accessing external innovation for additional pipeline opportunities. Now let's move to our clinical trials, focusing on Pambrelumab on slide four. Panbrevum is a wholly-owned asset in Phase III clinical trials for three high-value indications, IPF, LAPC, and DMD. Each one of these diseases represents an important unmet medical need, and each constitutes a significant market opportunity. As we recently announced, we have completed enrollment of Arcephalus 1.0, phase 3 study of 356 patients with idiopathic pulmonary fibrosis. The Cephras 1 phase 3 study is largely based on our phase 2 PRESS study, which demonstrated a meaningful reduction in lung function decline. Enrollment continues in our second Cephras phase 3 study. This is Cephras 2, and we look forward to updating you as that trial progresses. We completed enrollment of the LELANTUS-1 phase three clinical trial of panvrelumab in non-ambulatory patients with Duchenne muscular dystrophy, DMD, in the first quarter, and expect to complete enrollment of the LELANTUS-2 phase three clinical trial of panvrelumab in ambulatory patients with DMD in the second quarter. It is very exciting to be expecting data readouts for LELANTUS-1, 2, and Cephras I in 2023. And I want to thank our clinical development team for their efforts. Moving now to locally advanced pancreatic cancer. As discussed previously, we plan an interim analysis of event-free survival in the second quarter. Depending on the results and in consultation with the FDA, we will decide whether to file for accelerated approval. After making this decision, we will provide an update later this year. Regardless, the trial will continue to the primary endpoint of overall survival, and we expect top-line data in the first half of 2024. I'd now like to spend a few minutes highlighting our perspective on the significant commercial opportunity we see with PanreluMap in each of the three disease areas. on slide five, beginning with IPF. With a diagnosed prevalence of approximately 330,000 patients across the US, EU, China, and Japan, IPF represents a significant opportunity with the two approved IPF therapies generating almost $4 billion in net revenue in 2021. Despite this market size, there remains significant unmet need with these two approved therapies, as characterized by continued disease progression and challenging tolerability. There is a sentiment in the IPF community of limitations with the current therapies and a desire for additional therapeutic options. If the Phase III CFRS program produces similar results to the Phase II PRACE trial, We believe panbrelumar has the potential to help a sizable number of patients with IPF and be a very significant product for FibroTen. In the middle column, you can see the locally advanced pancreatic cancer opportunity. Pancreatic cancer represents one of the greatest unmet needs in oncology, given the diagnosed prevalence of almost 140,000 patients across the major regions combined with a low five-year disease-free survival rate of around 10%. There have been limited treatment advances in the non-metastatic setting over the last two decades, with the immune oncology therapies failing to demonstrate survival benefits over the current standard of care. Similar to IPF, there is limited late-stage development activity in non-metastatic pancreatic cancer, which creates a meaningful opportunity for panbrelumab if it can demonstrate an improvement in overall survival. As we said earlier, the LAPIS phase three trial is fully enrolled, and we look forward to seeing if panbrelumab could provide an important new treatment option. And finally, in the third column, we wrap up the panbrelumab market section with a snapshot of the DMD opportunity. While the prevalence of DMD is the lowest of the three indications we're pursuing, given the devastating nature of his diagnosis and the relentless disease progression, we're hopeful that the LELANTUS clinical trial program can lead to an approved therapy that is so needed by the DMD community. With corticosteroids as the current standard of care, patients commonly deal with troublesome side effects as they continue to experience disease progression and loss of ambulation. While the current approved exon skipping therapies produce an increase in dystrophin levels, they are targeted at a small portion of DND patients and have yet to demonstrate a meaningful clinical improvement in symptoms or disease progression. There's a clear need for therapies that can improve muscle function and prolong ablation by targeting the downstream pathological changes of DMD. We believe the anti-fibrotic mechanism of Convreluma may be a solution that can help these patients and their families. Now let's move to Roxadustan on slide six. Following the European Commission approval of Evrenzo for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease. Astellas has launched in Germany, the UK, Netherlands, Austria, and Nordic countries. While uptake has been slower than expected, the early feedback from healthcare providers prescribing Evrenzo has been positive. The anemia of CKD opportunity in Europe is significant. and Renzo has an important first-mover advantage relative to other HIF PHIs. Launches will commence in the other major EU markets later this year, pending positive reimbursement decisions. Despite significant discussions with AstraZeneca, we have not been able to find a path forward for AstraZeneca to fund further Ruxandustra development of anemia of CKD in the U.S., We continue to believe Roxadustat can address an admin need for patients with CKD anemia. It's important to note that we continue development of Roxadustat in MDS with top line phase three data expected in the first half of 2023. Moving now to China. Roxadustat was renewed in the NRDL for another two years beginning January 2022. As expected, this relisting was accompanied with a price reduction. As you can see on slide seven, we are reporting first quarter total Roxodustan Nelsos in China of $43.5 million by Fibrogen and the joint distribution entity, which is flat compared to the first quarter of 2021. This was driven by a greater than 70% increase in volume offset by the recent NRDL price reduction. We expect Roxadustat NEO sales growth for the full year in China, driven by significant growth in volume. FibroGems portion of Roxadustat NEO product revenue in China was $18.9 million for the first quarter on a U.S. GAAP basis. Juan will dive into further details in the finance update. Turning now to updated external market data on slide eight, Roxadusta continues to be the number one branded treatment for anemia CKD as measured by values shared in the category, which includes all ESA products on Roxadusta. We expect this category leadership to continue as Roxadusta volume continues to grow at a fast pace. Next, slide nine provides a snapshot of Roxadusta unit growth as indexed to December 2020 on the chart on the left, as well as year-over-year growth in the table on the right. Of note is the consistent unique growth of Roxas-Dustat while the leading ESA brand is slightly up, reflecting the anemia CKD market expansion that has been driven by Roxas-Dustat since its original NRDA listing in 2020. Now, it is worth taking a minute to comment on the COVID situation in China. As you are aware, lockdowns have been implemented to reduce the spread of COVID in a number of cities, including Shanghai and Beijing. Thus far, we have not seen an impact on Ruxatusta demand in China. Where we have seen an impact is in some of our clinical trial enrollment in China. We are and we will continue to monitor the situation closely closely as it evolves, and our thoughts are with our China employees during this difficult time. I will now turn the call over to our CFO, Juan Graham, for the financial update. Juan? Thank you, Enrique.
spk12: Before I provide my financial remarks, I would like to thank the FibreGen team in continuously challenging themselves to move our clinical trials forward. Despite an evolving and challenging COVID environment, our team has been able to complete enrollment for Cephros-1, a clinical trial for the treatment of idiopathic pulmonary fibrosis, as well as for Lelantos-1 clinical trials for treatments of Duchenne muscular dystrophy. I also want to acknowledge the efforts of our team in China that has been working tirelessly to support patients with CKD anemia in China. As mentioned, volume and access to rocks adduced has significantly increased, offsetting the NRDL price impact. While this result was what we had expected, I nonetheless want to acknowledge the efforts in this achievement during the first quarter. Now getting into our results for the quarter. Total revenue for the first quarter was as planned at $60.8 million compared to $38.4 million for the same period in 2021, and representing a growth of 58% quarter over quarter. The breakdown of revenue sources are as follows. We recorded $25 million in milestone payments from Astellas related to the Russian Federation approval of Ruxadustat, or Evrenzo, for the treatment of adult patients with symptomatic anemia associated with CKD. This amount is allocated as $22.6 million in license revenue and $2.4 million as development revenue. we recorded $18.9 million net product revenue for Raksa Dostad sales in China compared to $15.4 million in the first quarter of 2021. During the quarter, we also recorded development revenue of $11.8 million associated with co-development efforts for Raksa Dostad with our partners as compared to $14.6 million during the first quarter of 2021. Finally, we recorded $7.6 million in drug product revenue for Roxadustat bulk drug or active pharmaceutical ingredients sold to Astellas as compared to $8.5 million in the same period last year. Diving deeper into the operating results of our Roxadustat business in China, as previously stated by Enrique, Total Ruxabusta net sales from the joint distribution entity jointly owned by AstraZeneca and Fibrogen, or JDE, was $43.5 million for the first quarter in 2022, remaining flat as compared to the first quarter of 2021. This revenue is resulting from a significant volume increase of roughly 70% offsetting the recent price reduction due to the NRDL renewal. We continue to be encouraged by the growth for China operations and expect continued strong market penetration as experienced during this quarter. Flowing from the total Raksadustat net sales in China, Fibrogen's net transfer price from sales to the JDE was $13.9 million for the first quarter, consistent with the 30% to 45% range of the JDE's Raksadustat net sales, which we have continuously guided. During this quarter, we recorded $2.3 million released from deferred revenue due to change in our future estimates as per US GAAP. As we have communicated in the past, the deferred revenue balance in hydrogen china fluctuates based on estimates of future revenue. As a result, Fibrogen recorded $16.2 million in net revenue for the quarter from Ruxudustat sales to the JDE and $2.7 million of direct-to-distributor sales from Fibrogen China. As we continue down the P&L, operating costs and expenses were $123.8 million compared to $108.9 million for the first quarter in 2021. This increase in operating costs is primarily driven by R&D expenses supporting our Phase III clinical trials, including drug supply costs associated with our Pembrevlimab programs. While we continue to look for ways to accelerate activities related to our Pembrevlimab program, we also continue to maintain strong focus on cost control as evidenced by our flat year-over-year SG&A line. During the first quarter of 2022, net loss was $63.2 million, or 68 cents net loss per both basic and diluted shares, as compared to net loss of $71.8 million, or 78 cents per basic and diluted shares for the first quarter last year. At March 31st, we reported $565.4 million in cash, cash equivalents, investments, and accounts receivable. As we look forward, we estimate our 2022 ending balance of cash, cash equivalents, investments, and accounts receivable to be in the range of $310 to $340 million, which is an improvement over the previously communicated range of $270 to $300 million. While we believe we are appropriately financed through key initial PEM Revenue Update or readouts, we are privileged with a wide array of options to consider as we continue to look for opportunities to strengthen our cash position over time. Thank you. And now I would like to turn the call back over to Enrique.
spk02: Very good. Thank you, Juan. And in closing, we remain committed to, to advancing panrelumas of potential first-in-class medicine in Phase III development in three indications with significant admin medical needs, idiopathic pulmonary fibrosis, locally advanced unreceptable pancreatic cancer, and Yuxin muscular dystrophy. Roxadustat continues to perform very well in China. Our partner, Astellas, is moving forward with commercialization of Roxadustat in Europe. And we have additional regulatory submissions under review in other geographies. We're exploring options for Roxodustad in the U.S. and believe patients would benefit from having access to this treatment. As shown on slide 10, we continue to have a strong financial position with approximately $565.4 million in cash and expect to end 2022 with $310 to $340 million in cash. We have a strong cash position and have multiple options to consider to further strengthen our balance sheets to ensure our long-term success. But we are properly financed. We are privileged to be able to look at a number of those opportunities. Now I would like to turn the call back to the operator for questions.
spk04: Thank you. Ladies and gentlemen, if you would like to ask a question, please press star followed by the number one on your telephone keypad. Again, that is star, then the number one. To withdraw your question, please press the pound or D-hash-E. Please stand by while we compile the Q&A roster. Your first question comes from the line of Michael Yee with Jeffress. Your line is open.
spk10: Hey, Marieke. Thanks. Appreciate the update. We have two questions. With respect to Pemrevlimab in pancreatic cancer, I know there's an interim coming up shortly. Can you just remind us if it's positive, you would announce and say something and say you're going to go talk to the FDA and then you'd have to come back to us later with what the FDA says? Or if it's not positive, then you would hear nothing or what? Just remind us of the scenario tree there. And then second question is on Roxodustat. You made a very important comment about AstraZeneca and not having an agreement yet to fund another phase three. What is the next step there if there's a disagreement or what is the next step and when would be an update? Thank you.
spk02: Very good. Let me, thank you for your question, Michael. Let me first address the second part of your question. on Roxodustad in the U.S. clearly. AstraZeneca has exclusive rights in the U.S. for Roxodustad, so FibroGen and AstraZeneca have to work together to find a path forward for this product in the U.S. in an email CKD. Keep in mind that our Phase III trial for myelodysplastic anemia due to myelodysplastic syndromes continues. And as we related in this call, we expect a readout in the first half of next year. As we look at Roxodustat, and as we mentioned before, we have had meetings with the FDA, so we do think there is a path forward in terms of a what is the clinical trial that would be required, but we clearly need to be able to agree with this plan with AstraZeneca and find it in order to move forward. I'm going to allow now Mark Eisner to provide, Dr. Eisner to provide an answer to your question on the interim of LAPC, on event-free survival, and what are the different scenarios here, so he will provide a lot more color.
spk11: Yeah, thanks for the question, Michael. So as you said, we plan an interim analysis in Q2 of event-free survival. This will be conducted by an independent statistician as we at Fibrogen will remain blinded, and the independent DMC will receive this analysis. The DMC will then be able to inform us whether or not the data meets stringent predefined efficacy and safety criteria. If so, they will inform me as CMO and I will review the data and potentially consult with FDA about next steps. So if the data meet these predefined criteria and FDA is agreeable, we would then consider filing for an accelerated approval. If not, then we would just continue the trial to overall survival. And just to clarify, regardless, the trial will continue to overall survival. And we should be able to update you later in the year.
spk10: Got it. Thank you.
spk04: Your next question comes from the line of Andy Shea with William Blair. Your line is open.
spk03: Oh, great. Thanks for taking my question. So I have two. One is, you know, I really appreciate the granularity you provided across the three indications for penrevomab. Looking for the pancreatic cancer specifically, there are two standard of care. You know, as we kind of think about the potential TAM for Pirellumab, I'm just wondering if there's any sort of market research done on the distribution between gym abroxane usage and the Fofrironox usage.
spk02: Yeah, that is a really important question. Clearly, those are the background therapies that are being utilized in the trial. So it is PAM on top of Abraxin gem or Folfirinox in one of the arms vis-a-vis Folfirinox or Abraxin gem. in the control arm. So clearly that is something that is evolving, and it really matters whether it's metastatic or locally advanced and resectable pancreatic cancer. But what we're seeing is basically somewhat of a split. It varies with geography. Fulfurinox usage has been increasing over time. which is why we made an amendment in our clinical trial to ensure that that background therapy was available for patients. So we've conducted some more research, and we will provide a further update and more detail on this maybe during our next earnings call. Thank you for your interest.
spk03: Got it. Thanks. And then for my second question, you know, obviously for us who are more familiar with the Western pharmaceutical markets, you know, you know, kind of a 70% increase in usage is kind of unheard of. So just looking at slide number eight about the ESA and HIF market dynamics in China, there appears to be kind of an inflection point as we go from Q4 to Q1. Just curious about any additional information you could provide us with the market dynamics. It seems like, you know, the ESA usage has been ticking up as we head into 2022. Roxa has been going down. So any sort of additional context you can provide will be much appreciated there.
spk02: Yeah, I think as we mentioned, we've seen in China continued growth in our overall volume. The reason why you see a slight decline is because we are measuring value share, and when it comes to value share, given the price reduction of Roxa Doostat in the NRDL, that impacts the overall value share for Roxa Doostat. But it's not a reflection of the overall growth that we're seeing with Roxa in the market in China. I'm going to ask Chris Chang. I know she's in China now, and she is on the call on the phone, so I'm going to ask Chris if you'd like to provide maybe some more color on our performance in China as how we started the year in Q1.
spk01: Absolutely. Thank you, Enrique. So we started off very strongly in China this year, 2022, with the price decrease as a result of NRDL. As all of you know, ROXID is priced above ESA, There's a very strong value proposition. There's been affordability issues that I think with a lower pricing has been addressed. The volume uptake of 70 percent, of course, bodes very well for the rest of the year, so we continue to be very optimistic about what we could do for the rest of 2022. We believe this momentum is durable, and we are expecting net growth of 2020 to over 2021.
spk03: Got it. Thank you very much. I know it's difficult for you, Chris, so hang in there. Just best wishes to you.
spk01: Thank you.
spk04: Our next question comes from the line of Jeroen Werber with Cowen. Your line is open.
spk08: Great. Thanks for taking it. I have a couple of questions. Maybe just to start with on China, can you give us a sense maybe where you are now in terms of placement in the hospitals and in the community based on CKD and dialysis maybe as a percentage of your targeted market. And then secondly, when you think about moving to Pumrevlumab for IPF and the Zephyrus 1 study, when you look at the Phase 2, I believe about 8% to 12% of patients were receiving profanedone or TKI previously. What do you expect? So it was much more of a naive population. What do you expect that distribution to be in the Phase III and the Zephyrus I and II studies? Thank you. Okay, very good.
spk02: I'm going to ask Chris Chan to... answer the first question on China, and then Dr. Eisner will answer the second question on IPS and our Phase III study.
spk01: Thank you, Enrique. So, with respect to adoption and market potential, one thing, if you've looked at the slides that FibreGen has provided over time, since we've launched in China, the total market of ETA plus rhododendron has actually increased. So we believe the arena market is not the same as the ISA market. There is significant medical need that was previously not addressable with ISA, so we think there's a net growth in market size. We look at the three segments. We think we're still very early in the adoption curve, and there's tremendous growth opportunity in front of us. in terms of what percentage of the market we currently have. In the dialysis market, obviously the easiest market to get are the hyper-responders, people who are not performing as well as one would like on ESAs. We are doing very, very well in that market, as well as in the incident market. In the peritoneal dialysis market, given the oral administration nature of Roxidus, that we have a clear advantage. The wide open market is non-dialysis. because in the past it was very difficult for ESAs to penetrate it, and we have a clear efficacy and safety advantage over ESA in that market. So I think we're still very early on in the adoption curve, and we expect the total market to grow as adoption continues.
spk08: So regarding your – Enrique, if I can sneak in a question, maybe just on China. Is there any thought to monetize – That JV, either by spinning it out or selling it to Zeneca, is there any discussion, or is that core to your business and you'll keep it?
spk02: Yeah, I think we clearly have a very strong business in China right now, so there are no such plans at this stage. I'm going to have now Mark answer the second part of your question on IPF.
spk11: Right, so just to remind everyone, the Zephyrus IPF Phase III program is pemrevelamab monotherapy, but it does enroll treatment-naive and treatment-experienced patients in the program. Zephyrus I explicitly allows treatment-naive. Zephyrus II is going to be mostly treatment-experienced patients who have discontinued therapy. I think it's worth noting, though, that most patients discontinue standard of care with aspirator OFEV because of tolerability from GI side effects and other things, rather than treatment failure, per se, or progression of their lung function. So we actually expect both naive and experienced patients to potentially respond to Pamrevelinab similarly. This is our theory based on what we know about the disease. So thanks for your question.
spk04: Very good. Operator, take your question. Operator. Yes, sir. Your next question comes from the line of Annabelle Sunimi with Stiefel. Your line is open.
spk05: Hi. Thanks for taking my question. I had a couple. So for the LAPDIS trial in the pancreatic cancer, when you go to FDA to discuss the trial results, I guess if it's supportive, Is there any overall survival that you can draw from the prior resected patients or resectable patients from earlier trials that potentially support that acceleration? And can you share any data from those patients now? Are there any updates from those patients? And then the second question I have, obviously it seems like you're having trouble coming to an arrangement with AstraZeneca. on the U.S. side, and it seems like maybe the competitive landscape has improved a bit with the Acuvia CRL. So can you maybe go into some detail about what options you may be exploring, and is there any kind of cause for non-performance on the AstraZeneca side, given that they have exclusivity? Do they have some kind of onus to proceed or let it go. Thanks.
spk02: Yeah. Thank you for your question, Annabelle. I'm going to ask Mark to answer the first question on LAPIS, and I will answer the second question on Roxodustis.
spk11: Yeah. Thanks for the question. So just to remind everyone, the primary endpoint of the LAPIS trial is overall survival. And regardless of the EFS outcome, we will continue the trial until the OS endpoint. But it's important to note that OS is part of the EFS endpoint. Mortality is part of it. So that will be part of the evaluation at the interim analysis. And in terms of your specific question about updates on OS from earlier trials, we don't have any specific updates at this time, but we'll be able to share that in the future.
spk02: Yeah, regarding the second part of your question, you are correct. Clearly, AstraZeneca has exclusive rights in the U.S., and as part of that, which is very common in this type of agreement, they need to make commercially reasonable efforts. So thank you for your questions, Annabelle.
spk04: Your next question comes from the line of Jason Gerbery. with Bank of America. Your line is open.
spk07: Hi, this is Perry on the line for Jason. Thanks for taking our questions. First, I just wanted to get an idea of the volume increase from 4Q21 to 1Q22. I know you said 70% increase in volume from 4Q22. previous year, but could you discuss the difference between the previous quarter and this quarter? And then also whether the volume growth you're seeing is, I guess, what the breakdown between non-dialysis patients and dialysis patients is. And then I just have one other brief question on PAMREV and IPF after that.
spk02: Yeah, I'll ask Chris to start with a question to talk about maybe some of the color in China when it comes qualitatively to talk about where are we seeing the business increase. And then I'll have Juan comment on the first part of your question.
spk01: Sure, thank you, and thank you for the question. So with respect to the spike in January, there was a significant spike. We believe this is unit growth. So the NLDL crisis was implemented on effective January 1st. We believe that created a spike in demand, which was seen to be durable. The percentage of growth continued January into February into March. which is something we're very happy about. In terms of the volume increase of the first quarter relative to before, I believe was the question, it was over 30%. So there's a significant growth quarter to quarter. Just to be clear, the reason why we don't do quarter to quarter comparison is because there's tremendous seasonality in the calendar in China. because of national holidays, because of how the reimbursement budget is done at the local level, so I really did not focus on that. This is why we choose to compare quarter one 2021 over quarter one 2022. In terms of the adoption, we were very pleased to see an adoption in NDD, which we believe is the growth segment for this population. The number of patients treated on NDD picked up much more significantly than in dialysis. which would make sense because dialysis is about 90% reimbursed by the government, so it tends to be much less price sensitive. NDD is about 50% to 60% reimbursed. And also the oral feature is very advantageous if the affordability equation could be addressed. So we're very happy to see what we expected the lowering price to bring, which is a very high adoption increase in NDD. I hope I answered your question and get you back to it.
spk12: Thank you. I think Chris highlighted some of the major points related to the dynamics of ROXA in Q1. I think another point to highlight, as you may have seen in performance for ROXA in China as well in Q4, was and anticipation, and as well, movement in terms of revenue associated with an impending NRDL renewal. It's difficult to compare Q4 to Q1, given all those dynamics, in addition to, as Chris mentioned, the seasonality of revenue due to holidays and so on that happens in Q1. But please, I think we will continue to analyze this piece and provide perspective as we move forward.
spk07: Okay, thanks. That's very helpful. And then just a brief question on PAMREV. So it sounds like the, I'm just curious about the proportion of patients that typically are either unsuccessful in treatment with current standards of care, or it sounds like the majority of patients that move off therapy are due to intolerance. And then, so I guess the proportion of patients that that covers. And then in terms of the $4 billion market size, do you expect that, you know, the entry of PamRev to increase that market size, or is it more kind of taking away share from the current standard of care, the current standard of care?
spk02: Yeah, I'm going to ask Dr. Eisner to answer the first question. I assume your first question refers to IPF and in terms of looking at the treatment of the current standard of care and what are some of the failure rates. And I'm going to have Fain Wittig answer your second question on the commercial side.
spk11: Yeah, it's a really good question. I mean, I think you can appreciate, given that it's an ongoing Phase III trial, we really don't have firm estimates of the different patient subgroups, but we will do by the end of Zephyrus 1 and, of course, the program overall. And I think we'll be able to speak to all of those subgroups with the data that we generate. So stay tuned.
spk09: Hi, Perry. This is Thane. And just to follow on to what Mark just said and your question around patients who aren't able to tolerate it, There's pretty good documentation that says, you know, within a year after starting either one of the anti-fibrotics, about 40% of patients have stopped due to tolerability or other reasons, primarily due to tolerability, but there are a whole host of other reasons associated with taking a chronic therapy, especially when it involves multiple pills multiple times a day. And that's where we think we could have a really nice advantage for Pemrevlimab based upon its administration. In terms of where we believe the patients will come from, we think we have the ability to both capture share from existing antifibrotics as well as expand the market. It's pretty clear that there are a number of patients who are categorized as mild who don't get treated with antifibrotics primarily because clinicians have indicated to us, at least in a research setting, that they are weighing the benefits of the antifibrotic therapy relative to then the downsides of issues with tolerability, and they want to make sure that they understand how quickly a patient is progressing, but it's really because they think that the downsides outweigh the potential benefits. And so there are probably 45% of mild patients with IPF who are not treated with current antifibrotics. There's also a decent portion of the moderate categorized patients who are also not treated, and then an even larger portion of the patients who have progress to the severe stage of the disease that aren't treated with the current antifibrotics, either because clinicians, again, don't view the risk-benefit as being favorable or because they've fallen off therapy for tolerability or other reasons. So we think we've got an ability both to capture patients who would have otherwise gone on to an antifibrotic once pamrevumab was available, as well as capture patients who would not have gone on to an antifibrotic. Got it. Thank you. That's very helpful.
spk04: And there are no further questions over the phone line at this time. I would now like to turn the call back to Enrique for any additional and closing remarks.
spk02: Very good. Thank you very much to everyone. We appreciate your participation in today's investor call and your interest in Fibrogen. Please enjoy the rest of your day. Thank you very much.
spk04: Ladies and gentlemen, this concludes today's conference call. We thank you all for participating and you may now disconnect.
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