FibroGen Inc (FGEN) 2017 Q3 法說會逐字稿

Welcome to the FibroGen, Incorporated Third Quarter 2017 Financial Results Conference Call. My name is Adrian, and I will be your operator for today. (Operator Instructions) Please note this conference is being recorded. A webcast of this call will be available on the company website for 2 weeks from today's date. For opening remarks and introduction, I'll now turn the call over to Karen Bergman, Vice President, Investor Relations and Corporate Communications. Please go ahead.

Thank you, Adrian. Good afternoon, everyone, and welcome to FibroGen's Financial Results and Corporate Update Call for the Third Quarter of 2017. An archive of this webcast will be available on our website under Events and Presentations for two weeks. Joining today's call are Tom Neff, our Chief Executive Officer, who will start the call by discussing corporate update strategy and execution in our product development programs. Dr. Seth Porter, Vice President of Fibrosis Programs who will provide updates on our Pamrevlumab program across the disease indications. Dr. Peony Yu, Chief Medical Officer, who will discuss our recently accepted new drug application filing by the China Food and Drug Administration for Roxadustat. And Mr. Pat Cotroneo, Chief Financial Officer, who will review financial performance in the third quarter. Following all prepared remarks, we will open the call for Q&A where we will also be joined by Dr. Elias Kouchakji, Vice President, Clinical Development, Drug Safety and Pharmacovigilance.

On this call, we expect to make forward-looking statements regarding our business, including our collaborations with AstraZeneca and Astellas; financial guidance; the initiation, enrollment, design, conduct and results of our clinical trials; our regulatory strategies, our research and development activities; and certain other business matters.

For risks and uncertainties regarding our business and statements made on the call today as well as factors beyond our control that may cause differences between current expectations and actual results, we refer you to our Form 10-K for the fiscal year ended December 31, 2016, and quarterly reports, including our Form 10-Q for the period ended September 30, 2017, filed with the Securities and Exchange Commission. Copies of these filings can be found in the Investors section of our website. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise.

The format for today's call will include remarks from FibroGen's management team, and then we'll open the lines to answer your questions. A webcast of this conference call again will be available for replay on the Investors page on FibroGen's website at www.fibrogen.com.

And with that, it is my pleasure to turn the call over to our CEO, Tom Neff.

Thank you, Karen. Good afternoon. Thank you all for joining us today. The time period since July has been highly productive. We reported positive Phase II-B data from our randomized placebo-controlled double-blind study of Pamrevlumab in IPF and presented these data at the European Respiratory Society International Congress in September. We also achieved major milestones in our Roxadustat program. First, the CFDA has accepted our new drug application, or NDA, to support the registration of Roxadustat for the treatment of anemia associated with CKD in dialysis and in non-dialysis patients in China. This NDA submission triggered a milestone payment of $15 million from our partner AstraZeneca which was earned in Q4.

In addition, last week Astellas and FibroGen reported positive topline results from a Phase III peritoneal dialysis study which is the first completed Phase III Roxadustat study in Japan. Last quarter we shared topline IPF results from our Phase IIB study of Pamrevlumab as well as some analysis of that data. Today I will provide a couple of additional observations underscoring the impressive safety results. Perhaps the most striking result was that the number of Pamrevlumab patients who experienced decline in lung function of FVC percent predicted of 10% or more resulting in discontinuation of therapy was less than 15% of what was observed in the placebo arm. Another notable result was the study's safety profile mirrored the results seen in our prior exploratory study in this same subgroup of FVC percent predicted of 55%, percent predicted at entry, and received the same dose of 30mg/k every three weeks. These are the only two studies with this impressive safety record of any of the trials involving all the companies to date.

We have been focused on further bolstering our strong IP position in Pamrevlumab for treating IPF. We will be reporting more study data on FVC improvement and antifibrotic activity in the next few months.

Turning to our pancreatic cancer program, as we are reaching the end of our ongoing open label Phase II study, we continue to see higher rates in tumor resectablity and surgical resections in the Pamrevlumab treated patients versus patients receiving standard of care chemotherapy. We are now focused on working with regulatory authorities to develop a registrational path for this program.

With regard to Roxadustat, with our partners AZ and Astellas, we are moving closer to the completion of Roxadustat Phase III trials in CKD anemia in support of four independent registrational pathways globally. Apart from the NDA filing in China, multiple trials are nearing completion in the US, Europe and Japan and we continue to target an NDA filing with the US Food and Drug Administration in 2018, subject to accrual of sufficient number of unique MACE patients in both CKD non-dialysis and in dialysis for the pooled safety analysis required in CKD non-dialysis versus placebo and in dialysis versus ESA, respectively.

Following on our successful $120 million financing in April to support the expansion of Roxadustat beyond CKD in China, and then the announcement of positive Phase II data from Pamrevlumab in IPF in August, we further increased our cash reserves with a substantially oversubscribed $375 million financing completed mid to late August to facilitate development of Pamrevlumab in pivotal studies. We greatly appreciate the support we are receiving from the investment community and we are very committed to delivering the value creation that these funds made possible in our first in class fibrosis and fibroproliferation platforms and with our HIF anemia platform. We expect to end 2017 with approximately $750 million to $760 million of cash and cash equivalents.

A final introductory note for today, we are pleased to welcome Gerald Lema to FibroGen's Board of Directors. Gerald comes to us with more than 27 years of pharmaceutical healthcare and consumer commercial experience. He was a senior executive officer at Baxter International for over a decade, most recently as President of Baxter-Gambro, Asia Pacific and President and Chairman, Japan at the time of his retirement in 2015. Previously Gerald had been a senior executive at Abbott in areas of general management strategy and business development. We welcome Gerald. We are pleased to add his extensive experience and leadership in commercialization, finance and strategy in a specific region as well as Europe, Middle East, Africa, US and Latin America.

I will now ask Dr. Seth Porter to discuss the status of our Pamrevlumab product platform. Thank you, Seth. Go ahead, please.

Thank you, Tom. As Tom mentioned, the positive results of our randomized double-blind Phase II study in idiopathic pulmonary fibrosis were presented in oral session at the European Respiratory Society International Congress in September of this year. In the study main portion, 103 patients were randomized 1:1 to receive either Pamrevlumab or placebo for 45 weeks. Pamrevlumab met the primary efficacy endpoint of change of force of vital capacity, or FVC percent predicted, a measure of change in lung volume from baseline to week 48. Pamrevlumab demonstrated statistically significant reduction in FVC decline using a linear slope analysis method in the intent to treat population. This is the same method used for the nintedanib Phase III primary analysis and in published sensitivity analysis of the pirfenidone Phase III ASCEND trial.

The average decline in FVC percent predicted from baseline to week 48 was 2.85 in Pamrevlumab arm compared to 7.17 in the placebo arm with a statistically significant difference of 4.33. At week 48, Pamrevlumab treated patients had an average decrease in FVC of 129 ml, significantly lower than an average decrease of 308 ml in the patients receiving placebo. We observed that 31.4% of placebo patients experienced disease progression defined as a decline of 10% or more in FVC percent predicted or death compared to only 10% of Pamrevlumab treated patients.

Pamrevlumab was well tolerated and slowed IPF progression as monotherapy in this study and in our previous Phase II IPF clinical study. And in the 067 sub studies, Pamrevlumab was also well tolerated when administered in combination with either pirfenidone or nintedanib.

At the ERS meeting, we also presented results from a mouse model of radiation induced lung fibrosis. The study findings showed that Pamrevlumab monotherapy reduced fibrosis to a greater extent than did either pirfenidone or nintedanib monotherapy. Pamrevlumab in combination with either standard of care treatment did not show statistically significant improvement over Pamrevlumab monotherapy.

These preclinical data and clinical results from our Phase IIB trial will be presented this week at the Pulmonary Fibrosis Foundation Summit of this year, the conference for IPF patients, advocates and clinicians. An analysis of the results from the IPF Phase IIB study is ongoing and we anticipate continued reporting of these data in the months to come.

Switching to pancreatic cancer, in our ongoing pancreatic cancer clinical trial, we are continuing to observe an impact on resectability and surgical outcomes for Pamrevlumab treated patients as compared to standard of care chemotherapy. Our team will be working with thought leaders and regulators to design a registrational path for a potential new approach for the treatment of locally advanced pancreatic patients.

Switching to muscular dystrophy, our third indication, Duchenne Muscular Dystrophy or DMD, we are enrolling non-ambulatory patients in a Phase II open label study of Pamrevlumab. In this study we are evaluating the ability of Pamrevlumab to reduce the harmful effects of fibrosis in muscle tissue. In contrast to the recently approved exon skipping therapy that narrowly targets specific mutations in a DMD patient population, Pamrevlumab mechanism of action is not mutation specific. We are quite encouraged by the increase in interest expressed by parents, investigators and patient advocacy groups for this trial.

Thank you for your time today. And now back to Tom.

Thank you, Seth. Our next speaker will be Dr. Peony Yu to go over the anemia program. Peony?

Thank you, Tom. As you know, Roxadustat is our first in class HIF PHI an innovative oral agent for coordinated erythropoiesis. A Roxadustat Phase III program in CKD anemia in partnership with Astellas and AstraZeneca includes 15 Phase III studies with a total sample size of nearly 10,000 patients. This large program has been designed to meet registration requirements in 4 regulatory jurisdictions worldwide. I am pleased to update you on our progress.

In the US and EU Phase III CKD program, we have enrolled a substantial number of patients and continue to accumulate patient treatment data [audio interruption]. So sorry about any earlier interruption, so I will start the sentence over. In the US and European Phase III CKD program, we have enrolled a substantial number of patients and continue to accumulate patient treatment data in these 7 ongoing Phase II studies. Our Phase III safety data has been undergoing multiple periodic reviews by our independent Data Safety Monitoring Board or DSMB. And in the most recent review in the past week, they again recommended continuation of all trials without modification to current protocols.

In the Japan Phase III Program being conducted by our Partner Astellas, FibroGen and Astellas jointly reported positive topline results from the first completed Phase III trial. This study evaluated Roxadustat in 56 peritoneal dialysis patients, 13 ESA naive and 43 ESA conversion patients. In this study the ESA naive patients first underwent anemia correction and 92.3% of them, along with 74.4% of the ESA conversion patients, maintained their average hemoglobin levels within the target range of 10 to 12 grams per deciliter during the weeks of 18 to 24. Roxadustat was well tolerated and the preliminary safety result was consistent with Roxadustat's safety profile reported in previous clinical trials.

As for our CKD anemia program in China, you have heard the great news that our Roxadustat NDA for treatment of CKD anemia in dialysis and in non-dialysis patients has been accepted for review by the CFDA in China. The results from both Phase III studies, 806 and 808, are included in this NDA. Having met the primary endpoints in both Phase III studies, we also demonstrated efficacy and safety of Roxadustat over the 26-week study period. In addition, the efficacy and the dose requirements in Roxadustat treated patients were comparable in patients with and in those without inflammation, in both the dialysis and non-dialysis study. This is an important differentiation from ESAs, since hyporesponsiveness due to inflammation continues to be a major challenge in the current standard of care.

The durability of efficacy response and long-term safety were demonstrated in the subset of patients who participated in this 52-week open label safety extension. The safety profile was consistent with previous clinical trials with no new or unexpected safety signals identified.

Last week at the American Society of Nephrology Kidney Week meeting in New Orleans, or ASN, our poster presentation titled erythropoiesis induced by Roxadustat treatment of CKD anemia is not influenced by inflammation. Summarized, the consistent positive results in the comparison of responses in patients with and those without inflammation based on analyses of 4 of our Phase II studies. These results were well received by international nephrologists. We also met with an estimated 50 [KOLs] from China, FEASN, who expressed much enthusiasm for the clinical profile of Roxadustat, particularly on the responses from patients with inflammation, the reduction of hepcidin and the convenience of oral therapy.

We are also advancing Roxadustat development beyond anemia in CKD. The US Phase III clinical trial for anemia in myelodysplastic syndrome or MDS is expected to start in the fourth quarter of 2017. We also plan to initiate Phase II/III clinical study in the fourth quarter of 2017 -- well, okay, it may go to first quarter, 2018. We look forward to keeping you posted on clinical and regulatory advances of Roxadustat in CKD, MDS and potentially other anemia indications worldwide. I'd like to now turn the call back to Tom.

Thank you, Peony. Pat Cotroneo, our Chief Financial Officer, will now walk through financial highlights for the [second] quarter of the year. Pat?

Thank you, Tom. As announced today, total revenue for the quarter ended September 30, 2017, was $27.3 million. For the same period, operating expenses were $63.3 million and net loss was $37.7 million or $0.50 per basic and diluted share. Included in operating expenses for the quarter ended September 30, 2017, was an aggregate noncash portion totaling $11.5 million, of which $9.6 million was a result of stock-based compensation expense. As of September 30, 2017, FibroGen had $762.7 million in cash as compared to $356.8 million for the same period last year, reflecting the net returns of our two recent financings. For these purposes, total cash refers to cash, including cash, cash equivalents, receivables, investments consisting primarily of investment-grade corporate debt, and restricted time deposits related to our building lease. On our balance sheet, the category of long-term investments consists entirely of investment-grade corporate debt with remaining maturities of fewer than 2 years.

With the submission of our NDA filing for Roxadustat in China, we earned a $15 million milestone from our partner AstraZeneca during October, 2017. This milestone payment will be recognized as license and milestone revenue in the fourth quarter of 2017. On August 24, 2017, FibroGen closed a financing that raised net proceeds of $356.2 million following the announcement of positive topline results from our Pamrevlumab Phase IIB clinical study in IPF. A strong balance sheet allows us to invest and/or partner optimally in the development of our pipeline. We are currently projecting year-end cash balance in the range of $750 million to $760 million.

I will now turn the call back over to Tom.

Thank you, Pat. We are pleased to be able to share this progress with you today. I would now like to preview our upcoming milestones. Looking out over the next year, milestones for Pamrevlumab include on IPF we expect to unveil our Phase III program in the first half of 2018 once our team has developed optimized Phase III study protocols in alignment with health authorities. In pancreatic cancer we plan to gain FDA input on our registrational study in 2018. As to Roxadustat for CKD anemia, we are at an exciting point of clinical development in all four regions. We have submitted our NDA in China as you heard today and the Phase III studies are progressing in Japan. The US and EU Phase III programs are advancing on track. FibroGen as the IND holder will be responsible for US NDA submission with support from our partner AstraZeneca, while our EU partner Astellas will take the lead in the EMA submission.

For Roxadustat lifecycle management strategy, we are making clinical development plans for expanding anemia indications beyond CKD, especially into oncology related and inflammation related anemias. For myelodysplasia or MDS anemia in the US, we expect to initiate our phase III clinical study in Q4, 2017. For MDS anemia in China, the team is expecting to dose the first patient in this trial before Chinese New Year which may land in fourth quarter, 2017 or first quarter, 2018 on the western calendar. We and our partner AstraZeneca continue strategic planning in oncology related anemia indications and inflammation anemia conditions and hope to have a plan agreed upon by Q2, 2018.

With that, let me turn this call back to Karen for Q&A. Karen?

Thank you, Tom. Operator, if you could kindly open up the line for questions?

(Operator Instructions) Michael Yee, Jefferies.

Questions on two areas. One is on Pamrevlumab. Can you just comment about where you are with the HRCT imaging data? When you think you can present that and what the expectation should be around that data? And then on Roxadustat, I know you keep commenting about how the DSMB keeps having looks with no recommended changes. Can you just remind us if that's blinded or unblinded, what they're looking for, and what types of things would be a requirement to stop the study if there was actually a problem? Thanks so much.

Okay, Mike, I will offer a response for the IPF question and Seth can follow-up if more appropriate. Then Peony will do the DSMB question. With regard to HRCT, we have been very focused in the past few weeks on getting certain IP filings or patent filings completed. This has been primary focus for the team to get it out of the way. But the filings are for the prospect of considerably longer period of time. We estimate 7 to 9 years more than what would normally happen with biologics and generics in terms of property protection, intellectual property protection, proprietary position on the antibody. So that work, I think as of 2 or 3 days ago, our IP team and our key members of Pamrevlumab staff in IPF were agreeing they had gone through most of the analysis, we're almost done. So I expect that we will move onto matters such as the HRCT evaluations as the next step here in the process. So during Q4 probably is the most likely scenario there. Seth, do you want to add anything to that?

I think that's right. Obviously we are very interested in the HRCT outcomes. They looked very promising in their previous Phase II study. As we've said, the changes in FVC were remarkably similar between the 067 and the 049 study, and so we're anxious to see how the 067 data looks with regard to HRCT.

Peony, would you like to take on Michael's question about how the DSMB is structured, what data they're looking at and how they do the characterization?

Yes, Tom. Michael, the DSMB, as you know, their role is to protect patient safety. And it consists of experts in various specialties including nephrology, cardiology, statistics and neurology as well as internal medicine. So these DSMB members are very knowledgeable and established in their field. So in terms of the data that they evaluate includes the 7 Phase III studies that we used to support regulatory approval in the US and Europe plus one study, one Phase III study that Astella uses for reimbursement purpose. They evaluate the totality of the data, cumulative from the very first day up until the data that were transferred for the DSMB evaluation. They evaluate patient safety by looking at adverse events as well as serious adverse events at patient treatment arm, which the sponsors are not open to. In other words, we do not look at data by treatment arm versus the DSMB member evaluates safety data summarized by treatment arm. And at the end of each DSMB evaluation, they advise us on whether it is safe to continue these studies.

Okay, I think that's really helpful. So they can see it by arm. I appreciate that and congrats on the progress, guys.

Terence Flynn, Goldman Sachs.

This is actually Holly on for Terence and I have two questions. One, can you outline for us the next steps of commercialization of Roxa in China now that the NDA has been accepted? And then can you also talk about where you are with respect to building out your commercial footprint in China? Thanks

Clarify the first question please. What were you asking?

Asking about the next steps for commercialization of Roxa in China.

The first part was about the drug approval process? I just want to make sure I understood the question you're asking.

So basically what you are going to be doing to commercialize Roxa in China.

Okay. So we have a drug review and assessment process that goes on from now until sometime early next year at the staff level and then at the top at the Center for Drug Evaluation, CFDA, we think sometime by May/June next year. On the commercialization side, there has been planning ongoing for a couple of years now. The key focuses here will be to get the manufacturing licenses in Beijing as quickly as possible after we get the drug approval. Currently the estimate is that we are looking into September or October of next year for in Beijing. We are also, because of the air pollution in Beijing, all synthetic chemistry manufacturers have been requested to move their activities to areas outside of Beijing and in doing that we have been building a factory in Changzhou, China which is about 2.5 hours by fast train from Beijing to the northwest. And in Changzhou we expect to have licenses for API production in the first quarter of 2019. So as far as the matrix for manufacturing and supplying drug, those two sites, in Beijing and in Changzhou, will be providing in bulk drug to AstraZeneca at their site in Wuxi in China. The AstraZeneca team is by contract responsible for the launch and marketing activities in concert with FibroGen in areas such as medical affairs. And so there is an extensive plan that is place with regard to the rollout of Roxadustat. It's a very substantial amount of activity, so let me just try to summarize that we expect in the first year or so we will be selling without national level reimbursement just because of the timing of the reimbursement activities. However, we are planning on Provincial level reimbursement grants as rapidly as we can acquire them. Progressively over time in years 2 and 3 we expect to see more and more hospitals as customers and we expect to get the reimbursement in place. So these activities have been planned out very extensively and we'll be talking about them more in future calls.

Geoffrey Porges, Leerink.

Congratulations on the company's first NDA, that's a great milestone. First I wanted to ask about manufacturing for Pamrevlumab. You made some new risk statement disclosure. Do you have the manufacturing capacity and process that you can proceed to Phase III? Is that ready or are you still working on the process and/or the sources of supply such that that needs to be resolved before you can start Phase III? And then secondly, Tom, you made some comments about the NDA, the US NDA for Roxadustat suggesting that it was conditional upon further recruitment to the pivotal trials. Can you tell us what the assumptions are for those CKD studies in the US that are required for submitting that, completing that NDA next year? Is that just continuing at the current rate or do you have to accelerate the recruitment into those trials in order to make the 2018 timeline?

With regard to production of antibody, we have had a long-term relationship with a very capable CMO, contract manufacturing organization. About a year and a half ago, we decided to commission them to make a higher production version of Pamrevlumab. That activity goes on until early next year when we expect to do the validation runs on that higher productivity version of Pamrevlumab. Depending on the circumstance in the Phase III program, there's really two different activities here, one in IPF and the other in pancreatic cancer. We believe we could start Phase III in either one next year at the appropriate time given the existing stock of antibody. If indeed we are doing large studies in IPF, like for instance combination with existing approved medicines, we will move to the new version of Pamrevlumab at some juncture prior to reaching the 50th percentile of patients being treated with antibody in Phase III. We also have an ongoing set of negotiations with additional suppliers of antibodies who are quite interested in joining our primary CMO. So that's the picture and it's been relatively static for a while. We've been doing these things over a long-time period, progress has been good, and next acute data points are optimized process for the more efficient Pamrevlumab, upscaling validation, and FDA signoff on that version would be the key steps early next year.

Tom, just to clarify though, you will start Phase III in both of those indications, based on the inventory of existing process material?

We will be able to start either or both with existing inventory of material, either study or both studies. There are scenarios where we don't need to do the upscaling to get approved. But that will be addressed later and will be based on the facts at hand as they come. With respect to the questions on the anemia program, sometimes investors forget that these are event driven studies, so we have to be accountable for an adjudicated mass of unique patient MACE events, meaning a patient with one or more MACE events counts as one. And we have a count that we're agreed to deliver for both the dialysis studies, and that's versus ESA, and in the non-dialysis studies, and that is versus placebo. As we get closer, those counts take over the timetable because we need to hit the events. And up to now we've had a single forecast end of 2018. I expect in the next few months, we'll get better granulation on each of these counts as they are needed. Inside of the dialysis number, a portion is incident dialysis and the whole arena of inflammation and hepcidin which we'll also be looking at and commenting on at the appropriate time. But for the moment, just think of two big studies. One versus ESA in dialysis, the other versus placebo in non-dialysis. And we're looking at the counts as we get to the end and it's a very intricate calculation of the adjudication number that is performed. The teams are all looking at it and cross validating numbers and so on by the month as we get close. So that's the picture.

Andrew Tsai, William Blair.

This is kind of a follow-up to Holly's question about the China regulatory and reimbursement environment. So it appears to be that there is 3 steps. So approval, obtaining licensure, and followed by reimbursement. Do you have any sort of visibility about when the 3 distinct events are going to hit? And a second question has to do with reimbursement. So it seems like there is a lag time between approval and getting the full reimbursement, both on the national and local level. Is it possible for you to book sales before actually getting reimbursement decisions?

To go over the steps you've defined, I think it's a useful way to think about it, the drug approval is certainly one thing. The licensure for manufacturers is another. We have been given a framework where we can provide both the dialysis and non-dialysis data in one review and so the drug approval will be for each of dialysis and non-dialysis. The licensure for our facilities is mainly focused on making the drug in bulk and getting it to our partner AstraZeneca for the downstream activities. Reimbursement, there are couple of ways to do reimbursement. One is nationally, the other is provincially in China. There's a long history on these things then there's an added layer that the Chinese are reforming many, many practices around drug development now. So we expect various reforms to come soon. In general, the national level of reimbursement is once every 5 to 10 years it looks like. The Provincial level is more frequently in terms of new names being added. As it regards other sales, yes, it is possible to book sales before the reimbursement is gained. This is both in respect of us shipping drug to AstraZeneca, and in any case we are booking sales, but also as it relates to downstream demand, there is a pretty substantial private market in China for drug particularly with foreigners, diplomats and so on and other categories of people that have reasons to have what amounts to what you see in the US as insurance policies. As a small part, not a large part, but a small part of the market. Our primary focus though in China is to make and sell in China for China and so these reimbursement events are important. We do expect it will take a couple of years from initial drug approval to get the reimbursement all in place and negotiated. It's an intricate and elaborate process. So I hope -- does that answer your question?

Yes, very much so. Thank you.

Joel Beatty, Citi.

Thanks for taking the questions. First one is regarded to the way the data will be rolled out from the Phase III trials of Roxadustat. Given that there is a number of trials, would we see it rolled out the same way that we saw that first study from Japan announced last week with 5 more to come later on? Or could they be more grouped together by MACE pools. And then a second question is, can you help us understand what's important in the pancreatic cancer data that will be coming over the next couple of months or so and what is left to show given that earlier in the year I believe there was a statistically significant overall survival benefit shown at that time? Thank you.

Okay, Joel, so I'll handle the first question, but let me say that I'll have Dr. Kouchakji address the pancreatic cancer and what's going to be coming up here. With respect to your question of Japan that we had a first study and reported it when we received the information, this reflects the fact that in Japan, just like in Europe, we have licensed rights to Roxadustat to Astellas. And particularly in Japan, they inform us when the study reports are completed. And the discussion about whether or it's announceable is taken at that time. So this is a seriatim process. It's likely to be one by one in Japan. In the US and in Europe, in part because of the pooled MACE arrangement, it's much more likely that results will be announced in groups of studies. We haven't decided for sure, but the focus is on executing pooled MACE safety requirement properly. And in general, both unblinding and reporting of data, our people attempt to make it as coordinated as possible. So I think that's really the focus in US and Europe. Does that answer your question, Joel, on that front?

Yes. Thanks.

Okay, so on pancreatic, Elias, please?

Hi, Joel. The study has completed enrollment as we know this now. We are following these patients and collecting this data. The result is very promising and continues. As you know we published at ASCO GI at the beginning of the year some of our results. And currently we are in the discussion with our key opinion leaders in this field. There's a key vital statistician to take a look at what is our next step for a pivotal study that this could be considered as a registrational study. So we are in the process now of looking at the data, cleaning the data up, accumulating the results, and understanding where we go next in this program. We are very hopeful like I said, the result as we've seen it that it's still consistent, that we will have a good program for registrational process.

And we have no further questions at this time. I'll turn the call back over to Tom Neff for closing remarks.

Thank you all for joining the call today. I'd like to express my thanks to our FibroGen teams in the US and in China and to our partners and most of all to our investors. We are greatly gratified to see the support that we have gotten. It's an exciting time to be part of FibroGen with the global advancement of our product programs across multiple indications, our important work in China, and the strategic management of our resources. We look forward to keeping you posted on our progress in coming quarters and years. I'd like to wish everyone a good afternoon and evening.

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