FibroGen, Inc.
Q3 2016 Earnings Call Transcript

Published: 9 Nov 2016

[Operator:]

Welcome to the FibroGen, Inc. Third Quarter 2016 Conference Call. My name is Sherry, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded and a webcast of this call will be available on the company Web site for two weeks from today. For opening remarks and introduction, I would like to now turn the call over to Karen Bergman, Vice President, Investor Relations and Corporate Communications. Please go ahead.

[Karen Bergman:]

Thank you, Sherry. Good afternoon everyone, and thank you for joining this call. Today we are reporting financial results and corporate update for the third quarter of 2016. The call will be lead by Tom Neff, our CEO. Tom will start with an overview of our corporate strategy, performance, and then product programs, and will be joined by Dr. Peony Yu, Chief Medical Office, and she will provide clinical and regulatory updates focusing first on roxadustat, and our global anemia program in chronic kidney disease, and then on anemia associated with myelodysplastic syndrome. Ms. Chris Chung, Vice President of China Operations, will review the regulatory and commercial outlook for roxadustat for the treatment of anemia of dialysis and non-dialysis chronic kidney disease patients in China. Dr. Seth Porter, Vice President of Fibrosis Therapeutics, he will discuss FibroGen's clinical programs for pamrevlumab in several highly promising indications, including idiopathic pulmonary fibrosis, pancreatic cancer, and Duchenne muscular dystrophy. And Mr. Pat Cotroneo, Chief Financial Officer, will discuss financial performance in third quarter. 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 clinical trials, research and development activities, and certain other business matters. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes that are difficult to predict, many of which are outside of our control. For risks and uncertainties regarding our business and statements made on the call today, as well as factors 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, 2015 and quarterly report, including our Form 10-Q for the period ended September 30, 2016 filed with the Securities and Exchange Commission, copies of these filings can be found in the Investors section of our Web site. 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 will include remarks from FibroGen's management team, and then we'll open up the lines to take your questions. A webcast of this conference call will be available for replay on the Investors page at FibroGen's Web site, www.fibrogen.com. At this time, it is my pleasure to turn the call over to our CEO, Tom Neff.

[Tom Neff:]

Thank you, Karen. Good afternoon and thank you for joining us today on our conference call and webcast. In the third quarter, the FibroGen team worked diligently on advancing our major product programs roxadustat or FG-4592, and pamrevlumab or FG-3019 in clinical development. For any newcomers to FibroGen who are on this call today, we are focused on the development of first-in-class therapeutics in a number of potential indications, higher value therapeutic areas. Our most advanced program, roxadustat, currently in Phase 3, is based on the biology of hypoxia-inducible factor or HIF, and the use of HIF prolyl hydroxylases inhibitors to selectively activate coordinated erythropoiesis. Our Phase 2 program, pamrevlumab, is evaluated in anti-fibrotic therapeutic in fibrosis and proliferate [ph] diseases. We currently have four Phase 3 programs and encompassing 15 studies worldwide to support registration requirements in the U.S., Europe, China, and Japan. And we are expanding to anemia treatment in other patient populations. Under our agreements, our partners pay for development and commercialization worldwide with the exception of China, where we share 50% of the costs. Today, FibroGen and our partners, AstraZeneca and Astellas are focusing considerable resources on advancing the clinical development of roxadustat for the treatment of anemia prevalent in both dialyses and non-dialysis chronic kidney disease or CKD patients. Our two partnerships provide us with the advantages of being able to extend our resources and offset expenses, while prudently managing our investment in R&D and infrastructure, and our use of cash, and enabling significant participation of the downstream revenues. This includes the development and commercialization of roxadustat in Europe, Japan, and certain other territories that are being conducted with Astellas Pharma, development and commercialization of roxadustat in U.S., China, and all of the territories in the world are being conducted with AstraZeneca. Details on these agreements are available in our most recent 10-K and in other filings. In China, we recently announced the completion of patient enrollment in our Phase 3 studies. We now move quickly towards reporting top line data for both studies. Reporting 52-week safety assessment, and then completing our regulatory filing. We envision a significant growing role for roxadustat in the treatment of anemia and the areas of oncology and inflammation. In the U.S., we have just received FDA's acceptance of our IND, and have the green light to start our Phase 3 clinical development program in MDS, a serious disorder that impairs the ability of the bone marrow to produce healthy red blood cells. In China, following discussions with our regulator and our partner, we have filed a CTA or clinical trial application for the treatment of anemia in MDS patients, which is now under active review. We also plan to submit a CTA for chemotherapy induced anemia. The development costs for additional roxadustat indications are covered by our partners under the same arrangements as for chronic kidney disease, you know, Peony will discuss the roxadustat program in more detail shortly, and Chris will focus on our kind of strategy and the exciting achievements in that territory. Our next product candidate, pamrevlumab or FG-3019 is a first-in-class therapeutic in three Phase 2 programs, idiopathic pulmonary fibrosis, pancreatic cancer, and Duchenne muscular dystrophy. These are all severe, life-threatening diseases in need of innovative new therapeutics. Doctor Seth Porter will discuss progress we've made this quarter in the pamrevlumab clinical programs. Finally, I would like to briefly touch upon two aspects of our financial position. First, total cash at September 30 was $356.8 million, as compared with $365.6 million one year ago, reflecting a year-over-year decrease of $8.8 million. In our latest cash projection, we have increased the expected cash at the end of 2016 now to be in excess of $335 million. My second, and a related observation is about our cash burn rate, which is derived from our operating expenses net of our quarterly co-development reimbursements from partners less non-cash charges such as stock compensation and depreciation expense. It does not include milestone payments as you may recall. We had attained the AstraZeneca 50/50 cap for roxadustat development expenses outside of China, and at a full year without the 50/50 cost sharing, we'll be expected to reduce our cash burn rate significantly. Comparing burn rate may also help everyone understand the impact to cash flow reaching cost sharing cap and the effect of increasing reimbursements from agreed upon roxadustat development costs. With the foregoing information as a backdrop, our cash burn rate for Q3 2016 was $11.9 million. As a comparison, our cash burn rate the same period last year was $42.7 million. The principle reasons for the decline in burn rate are the impacts of reaching the 50/50 cost sharing cap with AstraZeneca, which both reduces OpEx, and increases reimbursements, and a steady increase in the reimbursable FTEs. I hope these statements are clear enough. We are happy to follow-up with you individually after this call. This will be the exciting year for FibroGen as we anticipate reporting news across our roxadustat and pamrevlumab development programs. I will summarize our 2017 milestones prior to opening the call up for your questions. I am now going to turn this over to Dr. Peony Yu, our Chief Medical Officer. Peony will provide further detail in chronic kidney disease, and our expansion into MDS. Peony?

[Peony Yu:]

Thank you, Tom. Anemia or the condition of not having enough red blood cells as measured by [technical difficulty] content; it's characterized by the blood's reduced capacity to carry oxygen. Depending on the severity, anemia can cause fatigue, dizziness, cognitive problems, heart failure, and other cardiovascular complications increased [indiscernible], need for blood transfusion, exacerbation of other serious medical conditions, and even death if untreated in extreme cases. Severe anemia is common in patients with serious chronic conditions, including chronic kidney disease or CKD, cancer, myelodysplastic syndrome, and inflammatory diseases. Roxadustat is an orally administered small molecule that corrects anemia by taking advantage of the biology of hypoxia-inducible factor or HIF. It activates coordinated erythropoiesis for the treatment of anemia associated with serious diseases. It operates by turning on the body's machinery for producing red blood cells, one which involves naturally activated when the body responds to reduced oxygen levels in the blood, such as when a person adapts to high altitude. This response involves the regulation of multiple coordinated complimentary processes to promote erythropoiesis, and thus increase the body's oxygen carrying capacity. We believe roxadustat has the potential to overcome the deleterious effects of anemia in multiple disease settings. The first indication is anemia in patients with chronic kidney disease, and roxadustat is the first HIP-PHI to enter Phase 3 clinical development. FibroGen continues to advance our global Phase 3 clinical program for roxadustat in CKD patients, in which we and our partners are pursuing in parallel the regulatory approvals in four major regions, the U.S., Europe, Japan, and China. This robust set of Phase 3 studies is well-supported by extensive clinical data from eight Phase 2 studies that consistently demonstrate roxadustat's efficacy in correcting and maintaining hemoglobin levels in a broad spectrum of chronic kidney patients who need anemia therapy. As Tom mentioned earlier, together with our partners, we are conducting a total of 15 Phase 3 studies globally to support these regulatory approval pathways. Our U.S. and European roxadustat Phase 3 programs include seven clinical studies being conducted by FibroGen, AstraZeneca, and Astellas at more than 1,000 study sites in 50 countries worldwide. We announced last quarter that we have achieved target enrollment in two of the three FibroGen sponsored trials. I'm happy to report that we have now reached initial target enrollment in all three of our Phase 3 studies. And we continue to add patients to the non-dialysis and incident dialysis trial in support of overall enrollment goals among the partners. We are on track to file an NDA for roxadustat in the U.S. in 2018. We are pleased to share with you that once again the Independent Data Safety Monitoring Board or DSMV with the responsibility for reviewing the global Phase 3 data met most recently in October, and recommended that these studies continue without modifications to the protocol. In Japan, our partner Astellas is making progress in Phase 3 roxadustat CKD program. The Phase 3 CKD program in Japan consists of six studies, four in dialysis patients and two in non-dialysis patients, covering treatment naive patients, as well as those switching from ESA. Studies are designed to show anemia correction or hemoglobin maintenance in CKD patients. We are pleased to note that results from the Japan Phase 2 study in CKD non-dialysis dependant patients will be presented at the upcoming American Society of Nephrology's 2016 meeting in the late-breaker session on Friday, November, 18. As a quick reminder, this is a 24-week placebo-controlled, double-blind study in 107 patients who were randomized to starting doses of 50 milligrams, 70 milligrams, or 100 milligrams of roxadustat or placebo, followed by dose titrations. Hemoglobin response was achieved in 93.8% of roxadustat treated patients as compared to 14.8% in the placebo arm. Roxadustat was well-tolerated and no death, and no major adverse cardiovascular events or [indiscernible] reported in the roxadustat patients. Turning to our program in China, we just announced the completion of patient enrollment in our Phase 3 clinical trials. I'd like to take a brief moment to walk through the design of these two studies. Our 806 dialysis study is a multi-center, open-label, active-control trial, in which 300 stable dialysis-dependant patients who have previously received ESA are randomized two-to-one to receive roxadustat or epoetin alfa. The primary efficacy endpoint is mean change in hemoglobin from baseline measured at 26 weeks. Our 806 non-dialysis study is a multi-center, double-blind, placebo-controlled trial, in which 150 patients were randomized two-to-one to receive roxadustat or placebo. Here the primary efficacy endpoint is mean change in hemoglobin from baseline measured at eight weeks, with treatment continuing through 26 weeks. At least 100 patients from these two studies combined will have a minimum of 52 weeks of exposure to roxadustat as part of their long-term safety assessment to be included in our upcoming China NDA submission. In August, the independent DSMB for the China Phase 3 studies recommended that these studies continue without modification to current protocols. We expect to report top line data from both of our China Phase 3 studies in early 2017. Beyond CKD anemia, we are pursuing other anemia indications in which roxadustat can address a met medical need. The first additional indication is anemia in patients with myelodysplastic syndrome or MDS for whom there is no approved drug in the U.S., Europe, or China. MDS patients often develop severe anemia, and in countries where blood transfusion is readily available, like in the U.S. or in certain European countries. Many of these patients become transfusion-dependant. The FDA recently completed review of our roxadustat IND in MDS anemia, granting us clearance to start our Phase 3 study. In countries such as China, where chronic transfusion is not readily available, anemia therapy is even more critical for MDS patients. As Tom mentioned, our MDS clinical trial application with CTA submission to the China Food and Drug Administration is under review. We are excited about the opportunity to conduct pivotal trials in MDS patients, and look forward to updating you further. Our next roxadustat indication being planned for China is chemotherapy-induced anemia. Thank you. And I will now hand the call back to Tom.

[Tom Neff:]

Thank you, Peony. I would like to introduce Chris Chung, who is the Managing Director of our China Operations. Chris, would you walk us through the current status of our roxadustat programs in China?

[Chris Chung:]

Sure, thank you Tom. We are exceptionally pleased that our Phase 3 enrollment was completed on schedule as of the end of Q3, 2016, for both the dialysis 806 study and the non-dialysis 808 study in China. We are delighted to be partnered with AstraZeneca in responding to a substantial unmet medical need in China for the treatment of anemia associated with chronic kidney disease, where the dialysis segment is growing rapidly, and the non-dialysis segment is still relatively untapped. We estimate there are 400,000 patients who are on dialysis. For context, in the United States there are 470,000 dialysis patients as of 2013, according to the United States National Registry, USRDS. The central government in China has established a mandate to make dialysis more accessible through expansion of reimbursement and the build-out of new dialysis facilities. We expect these factors to drive growth for the treatment of anemia is the dialysis population. While the size of the dialysis population is large and approaches that of the United States, it nevertheless falls short of the number who require dialysis patient treatment. The Minister of Health, in 2011, estimated that one to two million people in China were eligible for dialysis. This subpopulation of non-dialysis patients who would be receiving treatment in the United States and other regions with greater access to therapy are at risk for severe anemia. We believe roxadustat as an oral therapy is well-positioned to treat this group as well as the other more traditional non-dialysis population. As the demand for anemia therapy grows in China, we hope that with our highly promising first-in-class oral therapeutic, FibroGen will be able to make a significant difference in anemia care for these CKD patients. On the regulatory front, we are initiating the new drug application process this quarter. We continue to anticipate the completion of the 52-week assessment which is required to meet the ICH guidelines for approval of chronic drug therapy in the second quarter of 2017. In addition, we expect finalization of our regulatory submission in the second or third quarter of 2017. This positions China as the first country in which we expect to submit a new drug application for roxadustat. In China, we have attracted a highly talented group of pharmaceutical professionals with extensive experience in government regulations and local practice. To execute against our plans, we have made major strides in establishing an integrated organization which operates on a cost effective basis. The efficiency is due to our ability to leverage the expertise of the global roxadustat team here in the United States headquarters, and complement it with the specialized knowledge of our team in China. Moving on to the roxadustat program as it relates to anemia associated with MDS, as Peony mentioned, the Chinese Food and Drug Administration, or CFDA, is actively reviewing our Phase two-three clinical trial application. We hope to have an update on this program in the early second quarter. In China, anemia associated with MDS is an urgent unmet medical need because there's currently no ESA approved for the indication. And unlike in the U.S., blood supply for transfusion is severely limited. As Tom mentioned, we look forward to evaluating roxadustat in oncology and inflammation settings. In the near future, we intend to file a clinical trial application to initiate studies for the use of roxadustat in the treatment of chemotherapy-induced anemia. With that, I'd like to turn the call back to Tom.

[Tom Neff:]

Chris, thank you. Now I'd like to ask Dr. Seth Porter, our Vice President of Fibrosis Therapeutics to provide further comments on our second lead product program, pamrevlumab.

[Seth Porter:]

Thank you, Tom. Pamrevlumab or FG-3019 is a fully human monochrome antibody that works by inhibiting the activity of connected tissue growth factor or CTGF, directly associated with progression of fibrosis and some forms of cancer. As reported last quarter, we completed enrollment of the placebo-controlled portion of our ongoing Phase 3 randomized double-blind study. This trail is evaluating the safety and efficacy of pamrevlumab in idiopathic pulmonary fibrosis patients with mild to moderate disease. The primary efficacy endpoint is changed from baseline in forced vital capacity. The secondary endpoints include various assessments of pulmonary function, as well as extent of pulmonary fibrosis as measured by quantitative HRCT or high-resolution computed tomography. We are continuing enrollment in the 067 sub-study, in which patients will receive pamrevlumab in combination with approved IPF therapies. The study is designed to provide safety data needed for future pivotal trials. We expect to complete enrollment in this sub-study by year-end 2016, and to report top line data from the entire Phase 2 study in mid-summer, 2017. We recently presented data from the open label extension of our previous 049 IPS study at the ICLAF 2016 meeting, reporting that no safety issues were observed during prolonged treatment with pamrevlumab. 37 patients were initially enrolled in the extension study, and some have now been treated with pamrevlumab for up to five years. The trends regarding improved or stable pulmonary function and stable fibrosis that were observed during the initial trial were also seen in the extension study. For example, when patients discontinued pamrevlumab therapy, we saw a marked decline in pulmonary function, as you would expect in IPF patients. After restarting pamrevlumab treatment, these declines actually restabilized during the first year of the extension study. Further, the majority of patients who continued in the extension study showed prolonged stable fibrosis. Turning to our pancreatic cancer study, we are continuing to enroll locally advanced an open-labeled randomized Phase 2 trial targeting approximately 42 subjects. This trial is designed to evaluate pamrevlumab in combination with standard of care treatments, gemcitabine and nab-paclitaxel to see whether stage-3 inoperable patients can be converted to operable or resectable patients. We expect to report additional data in January 2017. Moving on to our clinical program for the treatment of Duchenne muscular dystrophy, or DMD, we are enrolling patients in an open label study of pamrevlumab. The primary endpoint is change in pulmonary function. Other endpoints include MRI assessment of cardiac fibrosis and function, MRI assessment of arm muscle fibrosis and fat, and evaluation of upper body strength and mobility. This trial is focused on wheelchair-bound non-ambulatory DMD young male patients, for which, there is little precedent. While this trial is enrolling more slowly than expected, we have strong support from our investigators and key opinion leaders. We are working on revisions to the trial protocol that we expect will enhance steady enrollment. Thank you for your time today, and now back to Tom.

[Tom Neff:]

Thank you, Seth. I would now like to introduce Pat Cotroneo, our Chief Financial Officer to walk through financial highlights for the third quarter. Pat?

[Pat Cotroneo:]

Thank you, Tom. As announced in our press release today, total revenue for the quarter ended September 30, 2016 was $30.1 million. For the same period, operating expenses were $52.2 million; a net loss was $24.2 million or $0.38 per basic and diluted share. Included in the operating expenses for the third quarter was an aggregate non-cash portion totaling $10.6 million, of which $8.5 million was a result of stock-based compensation expense. In terms of our total cash balance, as of September 30, 2016, we had $356.8 million as compared to $336.9 million at the end of 2015. For these purposes, total cash refers to cash, including restricted cash, cash equivalents, receivables, and investments. On our balance sheet, the category of long-term investments consists entirely of investment-grade corporate debt, with remaining maturities of up to 2.5 years. In addition to the favorable impact of the development expense reimbursement we described above, our financial statements reflect efficiencies in our operations, and a number of license and milestone payments that allow us to maintain a relatively consistent and strong cash position. In the second quarter we recognized a total of $72 million, which included a non-recurring upfront payment from AZ, as well as a milestone payment from Astellas. We are fortunate that these partnerships recognize multiple development and regulatory milestones, which in combination with the R&D reimbursement for our anemia program provide us with the flexibility with regard to the capital markets, partnering, and investing in our proprietary pipelines. As Tom noted earlier, we expect year-end cash to be in excess of $335 million. And I will now turn the call over to Tom.

[Tom Neff:]

Thank you, Pat. As promised, I'd like to preview our upcoming milestones. In the coming quarters, milestones for roxadustat include in China, we are initiating the new drug application process this quarter, and we expect to announce top line Phase 3 data in early 2017. We expect to report top line data from the 806 study in dialysis patients and the 808 study in non-dialysis patients in early 2017. Building on these top line clinical results, we anticipate reporting the 52-week safety assessment data in the second quarter of 2017. For our two MDS anemia programs in the U.S., our IND for Phase 3 study has been approved. We plan to provide an update in the early part of next year. In China, our CTA for anemia is currently under active regulatory review and we will provide an update once we get feedback from the regulators. For pamrevlumab, we are looking towards the following milestones. We anticipate top line results for Phase 2 placebo-controlled study of pamrevlumab to treat IPF, including data from combination therapy sub-study in mid summer 2017. We are continuing to enroll patients in our Phase 2 pancreatic cancer trial evaluating the potential to convert Stage 3 inoperable disease to resectable or operable disease with pamrevlumab in combination with chemotherapy. We expect reporting additional results from this study in January 2017 at ASCO GI. We are looking forward to a busy and eventful year.

[Karen Bergman:]

Operator, if you could kindly transition the all to Q&A.

[Operator:]

Thank you [Operator Instructions] Our first question comes from Michael Yee of RBC Capital Markets.

[Michael Yee:]

Hey guys, thanks. Hey Tom, congrats on the progress, hope you well. My first question was all the China Phase 3 studies that are about to readout. Maybe you or Peony can comment on your confidence in those studies and how we should interpret efficacy and safety into the other global Phase 3 studies that are going on, how should we think about that? And then as well with those global studies you've made some changes, some enrollment changes, modifications to protocols things like that. Can you talk about any of those and what the implications are and whether you still fully expect data in 2017? Talk about that a little bit. Thanks so much.

[Tom Neff:]

Michael, the second part of your question, could you repeat that please. I didn't quite follow.

[Michael Yee:]

Yes. So with these global Phase 3 studies that are going on as well, which was in the beginning readout time, can you talk about any of the changes that have been going on, such as [indiscernible] criteria et cetera, are there any implications to that et cetera, et cetera? Thanks so much.

[Tom Neff:]

I got it. Thank you. Peony, why don't you address the China part and the confidence interval and readouts under the other studies first, and we'll come back to the second one?

[Peony Yu:]

Okay, yes. Mike, thank you very much for the question. So we have -- our level of confidence for China is very high based on the fact that -- on what we understand the efficacy and the safety from our prior extensive Phase 2 trials. And I will go with our list of studies that we have conducted in [indiscernible] dialysis. So, in Phase 2 in the U.S., as you recall, our study 040 had treated patients up to 19 weeks and we have demonstrated [indiscernible] that stability to maintain hemoglobin efficaciously. We also had a study 053. It was a 12-week anemia correction study in incident dialysis patients who started out being very anemic. And then for the China study, it is a primary comparison period is 26 weeks. So, we fully expect that we're able reproduce the efficacy result. Now, in the non-dialysis study in China we have about 2

[Tom Neff:]

Thank you, Peony. Michael, for the non-dialysis studies globally, we were asked by FDA to enroll patients below hemoglobin 10. This resulted in a cohort that's different and unexpected in our patients that are below the baseline EGFR for dialysis. We have studied this very, very carefully and decided to go back and talk to FDA about how they are seeing that population. And that plan is starting with an expert meeting later this month and then we'll brief FDA thereafter. I should point that we still have ability in our studies to adjust enrolments and meet the original intended dates that are on the AstraZeneca Web site. Given all that we know right now, we believe that we can adapt to whatever circumstance in terms of feedback that we get in our enrolments. In dialysis, the only issue that has come up is the need for incident dialysis patients in the U.S. And there has been a lot of discussion about what would be an adequately sized study. Alignment on that was achieved about a year ago, and the efforts to make that incident population enroll are at full speed ahead of both companies, and again we don't have any reason to delay the dates from what's indicated on the AZ Web site. I hope that's clear enough.

[Michael Yee:]

Thank you. So, delays. Okay, thank you.

[Operator:]

Thank you. And our next question comes from Terence Flynn of Goldman Sachs.

[Terence Flynn:]

Hi, thanks for taking the questions. Maybe two from me, just wondering on China, if you can comment about the timing of roxa approval post the NDA filing. And then any additional details you can share on the roxa Phase 3 MDS program in the U.S., specifically design, endpoints, timing? Thanks a lot.

[Tom Neff:]

Okay. So Chris, I'll let you take the ball for the current project planning dates for launch of the product.

[Chris Chung:]

Sure. So, Terence, as you know the Chinese FDA implemented a wide range far-reaching and significant reforms to their regulatory approval process starting end of July, August 2015 timeframe. And on the positive side, we're seeing effects of how it has reduced the approval timeframe for, in particular, innovative drugs. We've also seen a number of new policies, including increased awareness and requirements for inspections that may on the other hand mitigate some of those gains. At this point in time when it's still early on in how the regulatory processes are being implemented, we are expecting an approval some time in the middle of 2018 timeframe plus or minus a couple of months, but we're quite confident that we will receive regulatory approval in the 2018 timeframe regardless of how the regulatory reform impacts us.

[Tom Neff:]

Thank you. And Peony, would you like to take on the study design from Phase 3 MDS in the U.S.?

[Peony Yu:]

Yes, we are happy to. We are very excited to have the opportunity to conduct this trial, the study has a small open label build up to 24 patients follow up by 160 patients rolled into what will be randomized into a double-blind placebo-controlled trial for patients will be lower risk MDS and are transfusion-dependent. The primary endpoint is present transfusion independence achieved by week 28, and this is a percent transfusion independence within any eight-week period during this primary assessment period, patients will be treated for a total of 52 weeks for safety assessment. And we -- our team is working diligently on study start-up and we will be happy to update you on the [indiscernible] in our next call.

[Terence Flynn:]

Thanks. And is there a control arm, an active control arm?

[Peony Yu:]

No the control arm is placebo as you know that there is no approved treatment for anemia in MDS patients in the U.S., Europe or in China and so when people pick control arm, you want to pick an arm that has been approved. So, since there isn't any, we are we have reached agreement with FDA on using placebo control; the patients will be treated with best supported care in this trial.

[Terence Flynn:]

Great, thank you.

[Tom Neff:]

Next question?

[Operator:]

Our next question comes from Geoffrey Porges of Leerink Partners.

[Geoffrey Porges:]

Thanks very much, I appreciate for taking the questions, congratulations on all. First on roxadustat, you're accumulating what seems like a vast amount of clinical data in your discussions with the FDA will you be able to submit the data from either the studies in Asia and Japan or from Europe to the application and contribute the safety data there and secondly you just highlighted the MDS particularly safety observation and is it your view that 52 weeks will be sufficient for safety for example the CIA and the other indications as well and I just have a quick question on 3019 as well.

[Karen Bergman:]

Yes. I'm sorry. This is Karen. Your line has quite a bit of fuzz and feedback on it. Can you repeat the core of those two questions for us?

[Geoffrey Porges:]

Oh, sure, I beg your pardon. So the question is you are accumulating a vast amount of data in Japan, China, and Europe. Will that be submittable for safety to U.S. application? Secondly, is 52 weeks sufficient duration you think for the FDA for all of the indications that you're studying? Thanks.

[Tom Neff:]

Okay. Geoff, the answer to the first question we are indeed accumulating lots of data, the way to think about it is that U.S. and Europe is in concert and take through why we're doing, what we are doing, I think you find that other people doing indications are going to be roughly in the same territory numbers, in Japan and China it's very different because we're essentially doing local approval programs and so we have to fulfill China standing alone based on the China regulations, Japan standing alone based on Japan regulations, so as a result when you look at the overall picture from the FDA's point of view, we are obligated to report all of the data from all the studies and all the countries at the time we file NDA in the U.S. And this is simply because of the safety aspects. The FDA wants to know everything that matters is on the table when they're looking at the review. The second question Peony, I think you're probably better off answering that question, if you want.

[Peony Yu:]

Okay. Yes, so the second question has to do with the safety follow-up for the…

[Geoffrey Porges:]

Yes, 52 weeks the sufficient safety then, this is a…

[Peony Yu:]

Yes so I believe that the different patient, the safety treatment, follow-up duration for a different indication are expected to be different for MDS we had explicit discussion with FDA regarding this 52 week follow-up being sufficient for that program. For the CKD out program are follow-up is a minimum of 52 weeks however because it is an event driven program that patients in these studies, in the CKD studies tend to be longer than 52 weeks. As far as your question about chemotherapy induced anemia for U.S. we are not able to provide guidance on that yet until we've further information.

[Geoffrey Porges:]

Thanks very much. That's very helpful.

[Tom Neff:]

Next question?

[Operator:]

Our next question comes from Keenan McKay of Credit Suisse.

[Slanix Alex:]

Hi, this is Slanix Alex calling in for Keenan. Thanks for taking the questions and congrats on the progress. I had a first quick question regarding the China opportunity. I would love to get your thoughts on, the eventual commercial opportunity in terms of adoption and maybe comparing and contrasting to that of your phase.

[Tom Neff:]

Chris would you like to take that on?

[Chris Chung:]

Sure. So Alex, I want to make sure I understand your question, you wanted to get a sense of how we look at the eventual commercial opportunity and compare and contrast it with ESA's correct?

[Slanix Alex:]

Yes, more in terms of just the adoption of the product there.

[Chris Chung:]

Okay, as stated earlier when we discuss the progress in China, we see the China market to be very compelling and in particular in two segments one is the dialysis segment I'll go into in just a second and the second is the non-dialysis segment in particular in dialysis stage non-dialysis patients so, in the dialysis segment right now the awareness treatment and complains rate for treatment of anemia in dialysis both in hemodialysis and peritoneal dialysis is over 80%. The de facto benchmark drought ESA as you stated. We believe we have a very compelling opportunity in China which would speak well for market adoption because unlike in the U.S. where it a de facto assumption that you be treated to target. In China, only 21% of the treated population actually reaches the published target of hemoglobin 11 and based on the latest statistics only 50% of the treated population actually gets to the acceptable target of hemoglobin can, I think if you were to study the data from our Phase 2 studies that you would see that treating to hemoglobin 10 or above or reaching 11 is not particularly challenging for our drug and within a very short period of time. So we think on a efficacy basis is very, very well for market adoption. We'll talk about reimbursement in just a second so, dialysis is the substitution market is a treated population. We think it speaks well based on efficacy and of course safety for conversion to health. In the non-dialysis population, the main reason why people not being treated is because of compliance so if you were at dialysis stage and you're an out patient population and you need to either do it intravenous or subcutaneous drug, the compliance rate as expected is very low. With this being an oral therapeutic, we think the adoption will be fast. The second is, I think in China the nephrologists are quite aware of the safety concerns in particular in terms of hypertensive side effects of ESAs. And in particular in the dialysis stage population where there are so many other comorbidities that they're concerned about. I think the safety of hip would speak very well to a market adoption but that is a market that we essentially have to build because it's not a very firmly followed standard of care to be treated in ESAs. So it is open territory the good news is the challenging news is we will have to build that market. In the earliest stage dialysis, on dialysis market we think – or therapeutic alone would speak very well for us because these are less severe and anemia patients where – and/or therapeutic that is safe. Efficacy is convenient and hopefully priced effectively would be something that we think it's a very compelling market opportunity for us.

[Tom Neff:]

One of the other factors and pretty much China is that the requirement of cold storage and sterility for uses really limits. They're used to the hospitals in which the dispensed. And we find that customer practices often are rapid dosing and reselect ones a day for three, four, five, six days and patients they're not in the hospital anymore and not getting uses anymore. And so we think there will be some very powerful substitution dynamics as this idea gets to be known across the country side in China.

[Peony Yu:]

Absolutely, Tom and one last point if I may add Alex is, as you know in China 95% of medical care is delivered through a hospital system. So when – I think the U.S. way to point to sale of thesis to the dialysis population is to some of very, very large dialysis [indiscernible] like Fresenius and DaVita. In China non-dialysis patients and dialysis are both treated in the same hospital, in the same Nephrology Department by the same Nephrologists. So we think adoption of hit in the dialysis segment, which speaks very well for adoption in the non-dialysis segment, because this is same point of sale for us.

[Tom Neff:]

Well said, next question please.

[Operator:]

Our next question comes from Tom Shrader of Stifel.

[Tom Shrader:]

Good afternoon. Just wanted to make sure, I heard correctly. So for the big Roxadustat program, are we still waiting on a big power in meeting between the partners or are you saying that has occurred, just say what -- I think you said?

[Tom Neff:]

So there are two segments, right?

[Tom Shrader:]

Yes.

[Tom Neff:]

And dialysis, this is not an issue. The only question is how to populate the degree of population needed for insulin and dialysis, that's a U.S. question, because U.S. allows much higher dosing and elsewhere. In non-dialysis, we are continuing to unroll and we are now above the targets that are in clinicaltrials.gov. And the process by which we're going to talk to FDA is to have an expert panel at the -- in November and then after that brief – compare the brief for FDA and meet them and discuss some of the non-anticipated aspects of the trial in the non-dialysis segment. Is that clear now?

[Tom Shrader:]

So this is the deal with the issue of patients crossing from non-dialysis to dialysis?

[Tom Neff:]

No, Tom, the issue is that when you haven't [indiscernible] the guideline or hemoglobin below 10…

[Tom Shrader:]

Yes.

[Tom Neff:]

It turns out you will end up with a lot of patients whose is baseline EGFRs are below dialysis [indiscernible].

[Tom Shrader:]

Right, okay.

[Tom Neff:]

So that pool of the population, the issue of some interest on our part that's going to be evaluated.

[Tom Shrader:]

But net-net you're seeing your incident dialysis assumptions are looking fine in terms of MACE events?

[Tom Neff:]

So that question here [indiscernible] just knows about non-dialysis that really [indiscernible] about dialysis. In dialysis, we have complete insulin enrollment in the U.S. That's our remaining goal. And sizing that study in timing it has been an issue, our focus for the partners for the several quarters, and we're going full speed ahead.

[Tom Shrader:]

Okay, and then one remedial question on chemotherapy induced anemia, outside of MDS, I thought that [indiscernible] got close down because they thought they were driving tumor growth. Is that correct? There is – is that an easy trial to – is that an easy area to approach or is that a kind of a subtle area to approach to make sure you're not driving tumor growth?

[Tom Neff:]

For reasons that are very hard to understand today. There were many, many studies done at really high doses of ESA.

[Tom Shrader:]

Yes.

[Tom Neff:]

And that those high doses, which we never see with roxadustat. There were off target effects, including Fibrosis reactive hypertensive responses and it is said tumor promotion. So the imagery there is [indiscernible] itself is triggering something or another. That is causing tumor. These doses were four to five orders of magnitude greater than when humans normally get to a physiologic dose, which is the range roxadustat is in. It was not part of that nerve. So it's clear?

[Tom Shrader:]

Yes, okay. Okay, thanks a lot for the answers.

[Peony Yu:]

So I may add something Tom?

[Tom Neff:]

Yep.

[Peony Yu:]

Okay, so the fact that those issues that you have brought up about driving tumor growth applies to the use of ESA. And I just wanted to remind ourselves that roxa is the HIF-PHI and has a completely different mechanism of action and just because ESA goes away in CIA that's not mean [indiscernible] in these patients all away. And so we are hoping that we can address that unmet medical need.

[Tom Shrader:]

Okay, thanks.

[Operator:]

Thank you. And then our next question is from the Joel Beatty of Citi.

[Joel Beatty:]

Thanks for the question. For the Phase III and DS [ph] trial, is there a timeline for the start? And then also when you think about the partnerships you have, which companies will be in charge of running their trial and which companies will be covering the cost of the trial?

[Tom Neff:]

Peony, you can do all that.

[Peony Yu:]

Okay, so I'll answer the second question first. FibroGen will be the Company that will be executing this study with support from our partners. And as for timeline, our team is working diligently on study start-up. So we are -- by the next call, we will be studying the better place to update you on where we are in the trial timeline.

[Joel Beatty:]

Okay, thanks. And then one other question on pamrevlumab, how are your patients -- do you expect might be in the -- in January?

[Tom Neff:]

Do you mean how many patients will be enrolled in a sub-study?

[Joel Beatty:]

No either that or how many patients you have the efficacy that on?

[Pat Cotroneo:]

So when we report top line efficacy in the middle of next summer, we will report on 103 subjects who are on the placebo controlled portion of the study. And then we're targeting 60 subjects, who will be in sub study, an additional 60 subjects were in a sub study, which there is some prominent dosing with pirfenidone or nintedanib.

[Tom Neff:]

The targets are 163, but we will stop the combination enrollment to be their timelines, so maybe [indiscernible] one way or the other. Let me go back and clarify one prior answer to prior question. In MDS, our partner in Europe has Astellas and they have indicated that they are supporting these studies and in the U.S. is AstraZeneca, and they have indicated they are supporting these studies. This means that all of the costs of the trial execution are reimbursed by our partners.

[Joel Beatty:]

Great, thank you. Thank you. At this time, this concludes the question-and-answer session. I would like to turn the call over to Tom Neff.

[Tom Neff:]

Well, so in conclusion, I'd like to thank everyone for participating in our call today. FibroGen is led by the pioneering biology that induce our pipeline programs and understanding of our target vision populations in the clinicians who treat them and I believe that our product pipeline demonstrators potential to improve care for multiple serious diseases. I would especially like to recognize my FibroGen colleagues in the U.S. and in China for their hard work and dedication. I would also like to thank our new and longstanding shareholders for their support and commitment. We look forward to updating you on our progress and to seeing you in our coming events, including The Stifel 2016 Health Care Conference in New York City on Tuesday November, 15. [Indiscernible] in San Francisco in November '16; the Citi Global Healthcare Conference 2016 in New York City on Wednesday, December, 8. And I would like everyone to enjoy their evening today. Thank you.

[Operator:]

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