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spk08: Good day and thanks for your standby. Welcome to the private gen second quarter 2021 financial results conference call. At this time, all participants are in listen on the moon. 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 the star one on your telephone keypad. If you require any further assistance, please press the star zero. As a reminder, this conference call is being recorded. I'd now like to turn the call over to Mr. Michael Tong. Please go ahead.
spk16: Thank you, Charlie. Good afternoon, everyone. Welcome to FibreGen's 2021 second quarter conference call. I'm Michael Tong, Vice President of Corporate Strategy and Investor Relations at FibreGen. Joining me on today's call are Enrique Quintero, our Chief Executive Officer, Pat Cotroneo, our Chief Financial Officer, Dr. Mark Eisner, our Chief Medical Officer, Dr. John Hunter, our Chief Scientific Officer, Thayne Wettig, 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 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 may include forward-looking statements based on FibroGen's current expectations. Such statements may include statements regarding to, but not limited to, our research and development activities, the initiation, enrollment, design, conduct, and results of clinical trials, our regulatory strategies and potential regulatory results, anticipated FDA interactions, commercialization and results of operations, risks, plans, market opportunity, and strategy related to our business, our collaborations with AstraZeneca and Astellas, financial guidance, and certain other business matters. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those anticipated in such statements. For discussion of these and other material risks and factors that could affect our future financial results in business, please refer to The disclosure in today's press release reporting our fiscal 2021 second 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 our statements are made as of today, August 9, 2021, based on information currently available to us, and FibreGen 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 second quarter financial results in a business update and a webcast of today's conference call can be found on the investor section of FibreGen's website at www.fibregen.com. With that, I would like to turn the call over to Enrique Quintero, our CEO. Enrique.
spk12: Thank you, Mike, and good afternoon, everyone, and welcome to our second quarter 2021 earnings call. Today, I would like to provide a high-level summary of 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. There is no question we are facing a significant challenge given the recent FDA Advisory Committee vote. However, Fibrogen continues to be positioned to create significant value for patients and shareholders by executing on the three areas of focus as shown on slide three. Number one, ensuring regulatory and commercial success of Roxadustat, a transformational medicine for the treatment of anemia, first in patients with chronic kidney disease and also with significant potential for expansion to treatment of additional indications. Number two, developing Pambrelumab in three indications with significant unmet medical need, locally advanced and resectable pancreatic cancer, Duchenne muscular dystrophy, and idiopathic pulmonary fibrosis. And number three is 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 an update of the regulatory status of Roxodustat, our continued strong performance in China, our clinical trial programs, and recent corporate developments. Let us get started with Roxadustan on slide four. In June, the CHMP of the European Medicines Agency adopted a positive opinion relating to the use of Roxadustan for the treatment of anemia associated with CKD. We expect a decision from the European Commission by the end of August. In July, the FDA Cardiovascular and Renal Drugs Advisory Committee voted to recommend not approving Roxadustat for the treatment of anemia of CKD. We and our partner, AstraZeneca, are in dialogue with the FDA and expect an action in the near future. During the quarter, Roxadustat was approved in South Korea to treat adult patients with anemia of CKD, and we have regulatory submissions in other territories under review. To support commercialization efforts worldwide, we have submitted manuscripts covering all primary phase three studies to peer-reviewed journals. As noted in slide five, 70 of these manuscripts have been published, encompassing both non-diagnosis-dependent and dialysis-dependent data. and we expect additional publications of the phase three data in the coming months. Moving now to China. As you can see on slide six, we are pleased to report total of the booster net sales to distributors in China of $52.8 million for the second quarter and $96.3 million for the first half of 2021. The increase in uptake continues to be driven by both an expansion in hospital listings and broad adoption within listed hospitals. Fabergen reported $13.4 million in China Roxadusta net product revenue for the second quarter of 2021 and $28.7 million for the first half of 2021. Hospital listings continue to be a key focus of our launch efforts, and at the end of the second quarter, Roxadusta was listed as a hospital that collectively represents approximately 81% of the CKD anemia market opportunity in China. As you can see on slide seven, the ESA market growth has accelerated since the inclusion of Roxadustat on the NRDL. In fact, ESA revenue over the last six months has shown meaningful growth over the same period in the prior year. Moving to slide eight, Roxadustat has driven the expansion of the anemia of CKD category over the past year and a half. In fact, Roxodustad captures 70% of the category growth and is capturing share in an expanding market. Finally, as shown on slide nine, Roxodustad is the number one branded treatment for anemia of CKD in China for the past five months, achieving a value share of 32% in the most recent month within the segment that includes all ESA products on roxacustat, currently the only HIF-PHI in the market. We look forward to keeping you updated as we advance our long-term goal of making roxacustat the standard of care in treating China's CKD anemia patients. Moving now to our clinical development programs on slide 10. COVID continues to create challenges to recruitment And today, we are updating our timelines, starting with Roxadustat. We recently completed Whitney, our Phase II trial in patients with chemotherapy-induced anemia, and look forward to sharing top-line data with you later this quarter. Top-line data of Matterhorn, our Phase III trial in patients with anemia or myelodysplastic syndromes, or MDS, is now expected to in the second half of 2022 or first half of 2023 versus prior guidance of the first half of 2022. In China, the blinded portion of the phase three trial of Roxadustad in patients with anemia of MDS has begun enrollment. Moving now to panbrevlimab, in locally advanced and resectable pancreatic cancer, an interim analysis of event-free survival for potential accelerated approval of our LAPIS phase III trial will be completed in the second half of 2022. Previously, the refraction rate was a surrogate endpoint for accelerated approval. After recent discussions with the FDA, we changed this endpoint to the event-free survival endpoint, which is composed of progression, death, and resection failure due to progression. This better reflects the potential clinical benefit in this patient population. During the second quarter, panbrelumab was included in the Pancreatic Cancer Action Network's precision promise, adaptive trial platform, which is evaluating panbrelumab and standard of care for patients with metastatic pancreatic cancer. Moving to Duchenne muscular dystrophy and rome continuous and allelanthus 1 phase 3 trial in non-ambulatory patients, with top-line data now expected in the first half 2023 versus prior guidance of second half 2022. Finally, in idiopathic pulmonary fibrosis, today we're pleased to provide guidance that we expect top-line data from our Cephris 1 phase 3 trial in mid-2023. These timelines assume current COVID conditions, and we will provide further updates as they become available. Moving now to the corporate update, we appointed Dr. John Hunter to the position of Chief Scientific Officer. Moving now to slide 11, in June, we announced our partnership with HiFiBio to advance next-generation therapies for patients with cancer and autoimmune disease, a deal which could enable up to three INDs by 2023. Fibrogen is accessing three new monoclonal antibodies against exciting targets, galactic 9, CXCR5, and CCR8. Galactic 9 is an oncology target with a reported role in acute myeloid leukemia and immune resistance in many solid tumors. Next, CXCR5 is an autoimmune and oncology target, and our primary interest is autoimmunity. But there are also opportunities in better cell lymphomas. Finally, CCR8 is an oncology target with broad potential in solid tumors. Now I would like to provide an update on our internal review. On April 6th, the company clarified the certain previously disclosed cardiovascular safety analysis from the Roxadustat Phase III program for the treatment of anemic and chronic kidney disease included post hoc changes to the stratification factors and provided additional data from the cardiovascular safety analysis with the pre-specified stratification factors. As stated at that time, the company initiated an internal review to ensure this does not occur in the future. We now have completed that review. Key company findings from the review are as follows. The underlying data used for the cardiovascular safety analysis are accurate, with no data integrity issues with the data used to generate such analysis. In its NDA, the company calculated accurately and described both set of analysis. including the statistical methodologies and stratification factors utilized. The statistical analysis using post hoc stratification factors were designated as primary analysis, and the statistical analysis using pre-specified stratification factors as sensitivity analysis. Those responsible for the statistical analysis believed it was a reasonable and valid way to analyze and present the data. Management is taking steps to ensure the company's processes are consistent with best practices in all respects. In addition to other processes and procedures, we plan to implement independent quality unity oversight of clinical data management, programming, analysis, and reporting. Furthermore, those directly responsible for the decision to use post hoc certification factors in the primary analysis no longer work for the company. The use of post hoc stratification factors was not discussed by the FDA Advisory Committee or referenced as a consideration that led to the Advisory Committee vote against recommending approval for Roxas-Dustat. We do not believe that it played any role in that vote. I will now turn the call over to our CFO, Falco Troneo, for the financial update. Pat?
spk15: Thank you, Enrique. As announced today, total revenue for the second quarter of 2021 was $24.4 million, as compared to $42.9 million for the second quarter of 2020. The current quarter revenue consists of $13.4 million net product revenue for Roxa-Dustat sales in China, $19.6 million in development revenue, and a negative $8.6 million in drug product revenue, which reflects our estimate of lower potential revenue from commercial batches shipped to date to AstraZeneca in the U.S. as a result of the recent unfavorable advisory committee votes. For the same period, operating costs and expenses were $158.2 million, and net loss was $134 million or $1.45 per basic and diluted share, as compared to operating costs and expenses of $128 million and a net loss of $85.3 million, or $0.95 per basic and diluted share, for the second quarter last year. Included in operating costs and expenses for the quarter ended June 30, 2021, was a one-time charge of $25 million related to our partnership with Hi5Bio, and an increase of approximately $20 million, which is primarily in Pemrevlumab development expenses, as compared to the second quarter last year. Operating costs and expenses for the quarter also included a non-cash charge of $19 million for stock-based compensation expense, as compared to $17.6 million for stock-based compensation expense for the same period in the prior year. At June 30, FibreGen had $640.5 million in cash, cash equivalents, restricted time deposits, investments, and receivables. As we have previously disclosed, starting the first quarter of 2021, the jointly-owned distribution entity, between AZ and Fibrogen, or the JDE, began selling Roxodustat to distributors and paying for AstraZeneca's commercialization efforts in China and AZ's portion of the profit share. Previously, Fibrogen was responsible for these items. To provide context for the operating results of our Roxodustat business in China, total Roxodustat net sales including sales through the JDE to its distributors, and Fibrogen China's direct sales to our distributors was $52.8 million for the second quarter of 2021. The JDE accounted for over 97% of the total China ROXADUSTAT sales volume. Our net transfer price from sales to the JDE was $17.1 million for the second quarter. which is within the 30 to 45% range of the JDE's ROXADUSTAT net sales to which we previously guided. After the net transfer price is determined, we defer a certain portion of such net transfer price for revenue recognition purposes under U.S. GAAP. As a result, Cybergene reported $13.4 million in China ROXADUSTAT net product revenue for the second quarter 2021. This amount also includes Fibrogen's adjusted net transfer price of $11.7 million from sales to the JDE, and the balance consisting of our direct sales to China distributors in China. Looking ahead at our broader financial picture, we have a total of $120 million and potential milestones expected for anticipated EU approval in DD and NDD by year-end. Based on our latest forecast, we estimate our 2021 ending balance of cash, cash equivalents, restricted time deposits, investments, and receivables to be in the range of $480 to $490 million, assuming EU ROXADUSDAT approval in 2021. Thank you. And I would now like to turn the call back over to Enrique.
spk12: Thank you, Pat. And in closing, rock seduced continues to perform very well in China. We expect a decision in Europe by the end of August, and we have multiple regulatory submissions under review in other geographies. Pamreluvav is a potential first-in-class medicine in Phase III developing in three indications with significant unmet medical needs. locally advanced and resectable pancreatic cancer, Duchenne muscular dystrophy, and idiopathic pulmonary fibrosis. Finally, we continue to advance our research agenda by advancing our internal candidates and accessing external innovation like the HiFiBio deal. As shown on slide 12, we continue to have a strong financial position with approximately $641 million in cash and another $120 million in anticipated Roxadusta milestone payments expected during 2021, assuming EU approval later this year. Now, I would like to turn the call back to the operator for questions.
spk08: As a reminder, if you have a question at this time, please press star then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, press the pound key. Please limit your question to one and one follow-up. Your first question comes from the line of Michael Yee with Jefferies. Your line is now open.
spk05: Hi, thanks. Good afternoon, Enrique. We just wanted to ask you about how to think about the upcoming next steps after whatever FDA decision comes. I mean, I think it's safe to say that the market assumes a negative decision, and if that's the case, How should we expect the ongoing partnership with AstraZeneca to progress, and are you having discussions that would include all options on the table? Maybe just talk to that, because I think that that's what people are trying to figure out what the next step would be in the U.S. Thank you.
spk12: Yeah, clearly I want to ensure that we don't get ahead of any FDA action, but clearly you have to assume that we're planning on all scenarios here. It's going to, of course, based on our discussions, and we had some discussions with both the FDA and AstraZeneca, we've been working basically to try to understand a potential path forward here. We expect a decision. I think it's difficult to say. We have not been given a timeline for that, but I think you witnessed the outcome just like we did. Of course, we were quite disappointed and surprised with the vote and how that discussion turned out and the final outcome of the vote. Clearly, under a scenario of a complete response letter, we'll need to see what the details are for that complete response letter. and make decisions appropriately. But there's no question under any of those scenarios we will have to make significant reallocation of resources and corresponding reduction in expenses with that. As I mentioned, we are expecting a decision in Europe by the end of this month, so we are excited about that. I don't know, Mark, if you want to make any additional comments.
spk14: No, thanks, Enrique. I think you summarized it well. I mean, we're working collaboratively with FDA and AstraZeneca to find the path forward, and we await the FDA's decision and next steps. Thank you.
spk08: Your next question comes from the line of Annabel Simini with Stifel. Your line is now open.
spk10: Hi. Thanks for taking my questions. And I apologize if I missed the initial comments. But maybe you can, you know, sort of talk to us about the chemotherapy-induced anemia studies. I saw that they were completed in clinicaltrials.gov. Can you tell us when and what form of that data might be reporting out? And is there anything that you can pull from these studies that might help you address some of the issues that you came across in the dialysis or the non-dialysis CKD studies. And yeah, that's essentially my question. I'll wait to follow up with my question.
spk12: So we've really finalized the Phase II study for chemoinduced anemia. And at this point in time, we're expecting to report top-line data imminently. I'm going to ask maybe Mark Eisner to provide some more color on whether any of this data can help any type of discussion with the FDA, and how do we think about this data?
spk14: Yeah, so thanks. It's an interesting question. I think the short answer is no. I mean, chemotherapy-induced anemia and CKD are very different indications, very different patient populations. So I don't see CIA informing the CKD decision or the assessment there. That said, we feel we're looking forward to see the top line data, the Phase II data. Looking forward to sharing those shortly and thinking about what the pathway could be for CIA as an indication.
spk10: Great, and if I could just ask on, you know, obviously it was clear from the panel that the physicians wanted to see a titration study, not a simulated modeling study of what titration could do. Given that these thrombotic events occur earlier in treatment, do you think that a titration study would be relatively short Is this something that could be conducted rapidly, or am I thinking about this incorrectly?
spk12: Mark?
spk14: Yeah, thanks for the question. Just to start out to say that, you know, we believe that the benefit-risk of roxidustat for the treatment of CKD anemia in both the NDD and DD populations is favorable with the dosing regimen that we studied in Phase III. But we did collaborate with FDA on some analyses, as you know, looking at rate of rise of hemoglobin and the relationship with thrombotic events. And we do believe that starting at a lower starting dose of roxidustat and titrating up would be a very reasonable approach to treating patients and mitigating the risk. We actually don't believe another trial is needed to prove that hypothesis. It's well established in the ESA field over the last two or three decades, and we're You know, we think the same applies with roxidustat. In terms of what study the FDA may or may not ask us to do, this remains an open question, and I think it's difficult to speculate right now, and we're just waiting for input from the agency on that.
spk08: Your next question comes from the line of Jopri Forges with SBB Learning. Your line is now open.
spk13: Thank you very much. Apologies, I was on mute. I was just wondering, could you tell us whether there's been any correspondence from the EMA since the ADCOM requesting additional information or analysis, or is the file that you originally submitted the only information you've been asked to provide? And then secondly, just in terms of the expenses, I think by the end of the year it looks like you'll have about $470 million in net cash, and you had a burn rate this quarter of $134 million. I know there were one-time items in that burn rate, but it looks as though by the end of the year you might have a year to a year and a half of cash left. What are the options you have for significantly reducing the company's cash burn so that you don't need to refinance the company at this greatly impaired valuation level? Thanks.
spk12: Marc, do you want to discuss the first part of the question? I'll discuss the burn rate.
spk14: Sure. So, the question is, since the ADCOM, has there been any communication from or to EMA? The answer to my knowledge is no, there's been none. And we don't anticipate any impact on the European Commission decision in August. Great. Thanks.
spk12: Yeah. On your question about the burn rate, First, I think we have no intention of raising money. I think we have, as I mentioned, a number of scenarios that we're working on. Clearly, under a scenario of a complete response letter, we would need to basically reassess our priorities and reallocate our resources and significantly decrease expenses. There are a number of plans that we have to ensure that we can deliver value for shareholders. And clearly, under this scenario, yes, we do have Roxadustat in China in a number of markets. And keep in mind that China is now basically profitable. And in the rest of the markets, we do not... We are reimbursed for any expenses, so we do not have any expenses when it comes to both commercial and development expenses. We will be getting a royalty. And, of course, we need to ensure that we can get to the readouts of Pambrelu map as soon as possible, so that's priority one. But, yeah, there's no question that we have to... ensure that we are going to be able to basically bridge for us to be able to see the data and be able to launch Pembreva.
spk13: Great. Thank you.
spk08: Your next question comes from the line of Edwin Zhang with HC Wainwright. Your line is now open.
spk03: Hi. Thanks for taking my question. On China revenue, can you help us understand Why the net ROXA revenue that FiberGem booked this quarter was 2 million less than last quarter, while the total net revenue and hospital listings were actually both increasing? Also, do you expect any ROXA pricing pressure in the upcoming NRDL negotiation in China? And then I have a follow-up.
spk12: Yeah, I'm going to ask maybe... Pat, to comment on the first question on the net revenue, the fabric and book, two million less, while the overall sales to distributors basically continuing to increase. By the way, of course, we see the overall net sales to distributors as really the fundamentals of the business and the one thing to be able to look at. We'll have Pat Cotroneo, our CFO, address that question, and then we'll have Chris talk about the NRDL and what are our expectations there.
spk15: Thank you, Enrique, and thank you for the question. To start, just as a reminder, as I mentioned on my prepared remarks, we have deferred revenue And this is from adjustments to our net transfer price to reflect U.S. GAAP. These adjustments are required for accounting purposes because we have manufacturing and supply obligations to the JDE over an estimated performance period. So what you're seeing here is just a deferral of a portion of the revenue to latter years. And, you know, as accordingly, We deferred $3.9 million in Q1 of 2021, and then approximately $5.4 million in Q2 of 2021. So this is strictly related to performance obligations and the gap requirements under revenue recognition rules.
spk12: Chris, can you comment on the NRDL?
spk07: Absolutely, Enrique. So, with regard to NRDL, as to the question of whether there will be a change in pricing starting next year, the answer is yes. Per the rules of NRDL, every single two years, the price is renegotiated. As you know, last time we entered NRDL in January 1st, 2020, and we will have a new price for 2022, January 1st. The direction of these negotiations is always downward. So it's not a question of whether, but how much. There is a very well established process in terms of how prices are determined. It's typically based on clinical value, and we stand behind the clinical value demonstrated by Roxodustat. And as you have seen in the very strong sales in the last couple of quarters, we also have very strong key opinion leader support from clinical key opinion leaders, pharmacologists, and pharmacies. Finally, And Fibrogen and AstraZeneca believe that we're uniquely positioned as an innovative drug to deliver value not just to patients but to the healthcare system. So we remain optimistic in terms of what the pricing outcome might look like in Q4 of this year.
spk03: Great. I have a follow-up on the U.S. I was also wondering what's your future plan on Roxa and CKD anemia in the U.S. Are you willing to do additional safety studies and prepare for resubmission some years later? Or would you rather drop the CTD anemia indication in the U.S., assuming Aroxa won't receive FDA approval? Thank you.
spk12: Yeah, as we mentioned, we don't want to speculate on the action by the FDA. And, of course, if we were to get a complete response letter, What would be the terms of that complete response letter? So it's difficult to comment on your question without having the action and any potential specifics there.
spk08: Your next question comes from the line of Jaron Werber with Cowan. Your line is now open.
spk02: Great. Thanks for taking my questions. I have a couple of questions that are interrelated, Enrique, if I can. The first one, just given valuations in China right now on companies in China that are dual listed or listing in Hong Kong, Has there ever been a discussion to see whether you should spin out the China sub into its own independent company and sort of rewrite the valuations there? And then secondly, depending on which way FDA goes here, from something small to a whole new study and a much more complicated development path, and in case AZN decides that this might not fit in with their strategy, can they exit the partnership in the U.S. but remain intact with you in China, or is it a one-size-fits-all? Thank you. Okay.
spk12: Yeah, clearly when it comes to China, we think that we have a meaningful business in China and meaningful capabilities as shown by the type of results and performance that we're basically getting there. And, yeah, we're looking at and we've looked at all options and we're looking at all options in China to ensure that the value that we have there is basically better reflected on our share price. So, yeah. That's something that we are very much looking at. When it comes to the partnership, the partnership with both Stellas and AstraZeneca is very collaborative at this stage, despite the very negative outcome of the outcome that we had in the U.S. And I expect that's going to continue to be the case. We clearly want to see the FDA action. And we do have additional indications that we're pursuing. Keep in mind that MDS is a phase three trial ongoing, and we are about to see the CIA data. And of course, based on that underlying data, we will be making a decision about how do we proceed with that indication.
spk08: Your next question comes from the line of Andy Isha with William Blair. Your line is now open.
spk04: Oh, great. Thanks for taking my question. So, you know, one of the take-home messages from the adcom is that there is tremendous, you know, interest from the physician community about the hypo-responders. So, you know, I'm not asking about, you know, making projections, but I want to understand the collaboration framework. So let's say, hypothetically, If the parties decide to go forward with that, you know, study, how is the decision being made? Is there like a joint steering committee across the three companies to make a go and no-go decision? And then also, I guess from a financials perspective, is there additional cost from a Fibrogen, you know, standpoint on R&D or you have already hit the limit? Yeah, and then the second question I have for Chris, you know, looking at slide number eight, you know, it seems like the ESA market in China is growing, and then, you know, it seems like, you know, you're basically growing both the ESA and obviously the ROXADUSA. I'm just curious, you know, if you can comment on the dynamic. Are you kind of growing the market, or is there also some element of switching from ESA? Thank you.
spk12: Yeah. Maybe just let me try to address the question about Fibrogen's expenses when it comes to commercial or development expenses for Ruxudustat. As I mentioned, outside of China, we have no expenses related to Ruxudustat, either on the commercial or development side. So we are fully reimbursed, and that would be the case as well if we were to pursue additional trials. I'm going to ask maybe Mark to comment on the governance that we have, how are decisions made when it comes to additional trials. In particular, I think there was this question about trials in ESA hyper-responders. Mark?
spk14: Right. So the ESA hyper-responder group, I mean, you're quite right. Several members of the advisory committee noted that that was a high unmet need for patients. And we're intrigued by our data, both in patients with high systemic inflammation and functional iron deficiency. Actually, we have some data that do suggest RoxDustat is effective in ESA hyper-responders. If we were to embark on another trial, it would be a joint decision between FibroGen and AstraZeneca and FibroGen and Astellas. I mean, we have joint steering committee governance at the higher level, and we have governance at a more team level level. with both companies, and we aim to make decisions that are good for the tripartite and that everyone is aligned on. So we do have good governance procedures in place, highly collaborative relationships with both companies, and once we know what the FDA's expectations are, we'll be in a good position to move forward.
spk12: And, Chris, if you could comment on ROXA in China, whether it's just growing the market or it's also there's capturing new patients versus just the switching. I don't know if you could provide some additional color to that.
spk07: Absolutely, Enrique. So the answer to the question is it is both. The category of ESA and HIF together in the class of anemia treating agents is growing. It's growing because there is increased awareness of the importance of treating the disease. The class share of HIF is also growing, and we are seeing conversion of patients from ESA to HIF.
spk08: Your next question comes from the line of my apologies now.
spk16: Just keep going. Charlie, you can keep going.
spk08: Thank you, sir. Your next question comes from the line at Difei Yang with Missouri. Your line is now open.
spk06: Hi, good afternoon, and thanks for taking my question. I'm just curious, how do the Chinese doctors react to clearly a split opinion between the EU regulatory agency versus the U.S.? And do you expect... this discrepancy will eventually lead to some changes in the demand for ROXA in China.
spk12: I'm going to ask Chris to maybe comment on the reaction in China, and I will try to complement Chris's comments.
spk07: Absolutely. China has a slightly different patient population than what was covered in the global trials. And based on our historical phase three experience, as well as real world evidence based on two and a half years of on market use in China, our Chinese key opinion leaders are seeing slightly different event rates. At this point in time, we're not seeing any over concern by our key investigators and key opinion leaders and HCPs about the U.S. regulatory guidance based on the adcom. As you know, every single health authority makes its own sovereign decision. Fibrogen China sought approval of China based on a domestic class 1.1 pathway, which meant that the data was only based on China data And to date, our real-world evidence is consistent with that experience. So at this point in time, we're not expecting any impact or any significant impact on prescription levels and continued widespread adoption of Roxiduset in China based on the ATCOM outcome.
spk12: Okay, thank you. I think it's fair to say we, as part of the ATCOM, we shared some data on... real-world data when it comes to pharmacovigilance in China. And as we saw, some of the reported rates in the real world when it comes to thrombosis, for example, were very, very low.
spk06: Okay, thank you for that. And then my other question is related to the delays in some of the trials, more specifically the MDS trial. And as well, I'm sorry, let me, yeah, it's the MDS trial as well as the DMD trial. And so could you give us a little bit more color of what's causing this? Is it a slow enrollment or is it something else?
spk12: Yeah, we will provide a little bit of comment. It is really related to enrollment. And, of course, enrollment is also impacted by current conditions. And we are seeing right now conditions that are more challenging due to COVID, so some of the COVID concerns. And clearly that creates a bit of a disproportionate impact. When we look at our trials in three patient populations, MDS, DMD and IPF. And the current timelapse that we provided assumed that these current conditions basically continue on. Mark, would you like to share more color?
spk14: Sure, Enrique. And I agree with the comments about COVID. I mean, for MDS, as you know, I mean, it's a rare disease. It's a 52-week placebo-controlled period. You know, so it's challenging to find the patients to enroll. We have opened up more than 40 additional sites around the world, and we are seeing increases in enrollment in those sites. So we're making every effort to enroll the MDS trials. And the way I would characterize it is it's just there's a lot of uncertainty around the enrollment rates month to month, and we are pushing very hard, though, and working very collaboratively with our investigators to enroll those trials. I mean, DMD, you know, similarly a very rare disease. You know, these are young kids in many cases in the COVID situation looms large for the parents of those children and those children. So again, we're trying very hard to make those trials as user-friendly as possible and doing everything we can to enroll those. On the positive side, I mean, the PAM-Revlimab LAPC trials are actually enrolling very, very well, which I think speaks to the high medical need in that condition and the excitement around PAM for those conditions. So that's very favorable. And, you know, the Zephyrus-1 IPF timelines, you know, we've announced for the first time publicly because we are making very good headway with enrollment there despite COVID, adding additional sites, working closely with the sites to enroll those patients. And also, you know, with the Galapagos-Gilead discontinuation, you know, we've been working to try to capture the patients who otherwise would have been candidates for those trials into our trial. So that's looking pretty good right now.
spk08: Your next question comes from the line of Paul Choi with Goldman Sachs. Your line is now open.
spk01: Hi, everyone. Thank you for taking our questions. This is Charlie on for Paul. I just had a quick one regarding the upcoming European decision and subsequent events. How are conversations going with partner Estelas for the region? Are they talking about their cooperation? commercialization strategies pending the approval with the EMA? Are they going to be focusing on certain countries at this point? And are they incorporating any sort of kind of virtual or remote marketing efforts considering the potential threat for further COVID lockdowns later this year? Thank you very much.
spk12: Very good. I'm going to ask our Chief Commercial Officer, Thayne Wettick, to provide some comments on the commercialization strategies in Europe, whatever we can share. Thanks.
spk11: Yeah, thanks, Enrique, and thanks, Charlie, for your message. Unfortunately, we're not going to be able to comment very much. Astellas, as you can imagine, in a highly competitive situation, there are certain things that they're not going to disclose, and we can't disclose on their behalf. I think what you could assume is that relative to a European launch, it's going to take the form of of other products that would be launching in Europe. So the traditional markets that are first to launch will be the traditional markets that will be first to launch for Roxadustat in Europe as they then work through the other markets from a pricing and reimbursement perspective. Needless to say, there's a lot of excitement because we do have a really nice competitive advantage in the EU from a timing perspective, and I think you can rest assured that Estelle is going to take full advantage of that.
spk12: One, just to remind everyone that Astellas has guided to revenue of $80 million for fiscal year 2021. That $80 million, it was converted at the exchange rates at the time from yen. About half of that was Japan, if I recall correctly, and about half of that for Astellas was basically Europe outside of Japan. And Astellas also provided, as part of their strategic review, an overall peak sales expected for the product, which, once again, I'm translating from exchange rates at that time, but there were somewhere between half a billion U.S. dollars to a billion U.S. dollars in peak revenue when we look at the Astellas territories.
spk08: My apologies. Your next question comes from the line of Jason Gerberry with Bank of America. Your line stands open.
spk09: Hi, this is Perry on the line for Jason. Thanks for taking our question. I have another regarding the CHMP opinion. Is there any risk that it doesn't stick? And additionally, what are the next steps from a regulatory standpoint, and when can we expect to get a label in Europe? Thanks.
spk12: As I mentioned, we're expecting a decision this month. We are expecting a European Commission decision. Clearly, the scientific body assessed Roxadustat as having a clear benefit-risk profile. Keep in mind that many of the items that were discussed here were discussed as part of the review in Europe. And I'm going to ask maybe Mark to maybe make a few additional comments.
spk14: I think the point Enrique made is a key one, which is the CHMP has already reviewed all of the efficacy and safety issues that have been up for discussion in the U.S. and issued a positive opinion. We think the European Commission decision will be positive. We don't expect an influence of the U.S. FDA's adcom on that decision. In terms of next steps for regulatory in Europe, I believe it's just waiting for that EC decision. And then that's the point in time where the product insert, the SMPC in Europe will become available. So that's basically the regulatory situation in Europe.
spk08: Thank you. We have no further question at this time. I will now turn the call back to our presenters for closing remarks.
spk12: Very good. I just want to, once again, just thank everyone for participating. We very much appreciate your participation today in the investor call and your interest in Fiverr Gen. Please enjoy the rest of your day. Thank you very much.
spk08: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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