Welcome to the First Quarter 2016 FibroGen Earnings Conference Call. My name is Anna, 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 this conference is being recorded. I will now turn the call over to Jennifer Williams. Jennifer, you may begin.

Thank you. Good afternoon and thank you all for joining our call. 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, and many of which are outside of our control. For risks and uncertainties regarding or 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 Form 10-Q for the quarterly period ended March 31, 2016 filed with the SEC, copies of which 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. A webcast of this conference call will be available for replay on the Investor page at FibroGen’s website, www.fibrogen.com. I will now hand the call over to Tom Neff, Chief Executive Officer of FibroGen.

Thank you, Jennifer. Good afternoon to everyone. Thank you for joining us on today's call. We will provide updates to our programs, discuss recent accomplishments and highlight key near-term and long-term goals. Joining me for the discussion today are Mr. Pat Cotroneo, Chief Financial Officer; Dr. Peony Yu, Chief Medical Officer; Ms. Chris Chung, Vice President of China operations; and Dr. Seth Porter, Vice President of Fibrosis Therapeutics. Let me start with some updates on our CKD anemia program in the U.S., China and Japan. And then our Phase 2 studies with 3019. With respect to the U.S. program, we had agreed with AstraZeneca, our U.S. partner that FibroGen would enroll its Phase 3 studies with a baseline goal of completing target enrollments by April/May 2016 and if possible, meeting stretched goal of achieving those targets by December 2015. At this point, the update for the three FibroGen sponsored studies is as follows; in study 064 which is dialysis conversion patients, 600 patients total, we beat the stretched goal and reach our agreed upon target in September 2015 and studied 060 pre-dialysis, 600 patients. We reached the agreed upon enrollment target at the beginning of March 2016. And study 063 which is a larger study involving incident dialysis patients, meaning patients new to dialysis for which target enrollment was 750. We reported on the last call that we and AstraZeneca decided to focus on enrollment of U.S. patients in this study and we expect to enter this modified enrollment plan to reach our -- enrollment target as of Q3 2016. At present I'm pleased to report the we have enrolled over 80% of the 750 patients of the target agreed to with AstraZeneca. And we expect to meet our target enrollment in Q3 2016. As we noted in our last…

Thank you, Tom. As Tom stated, the Phase 3 program continues to progress nicely. Our roxadustat global clinical regulatory strategy includes four independent regulatory improvement pathway; U.S., Europe, China and Japan, all are moving forward with very good momentum. We enter Phase 3 with expensive Phase 2 data including roxadustat correction and maintenance of hemoglobin levels in dialysis and non-dialysis CKD patients in the presence of inflammation and without a need for supplemental intravenous in patients of different ethnicities in multiple regions. I would like to address a recent roxadustat publication presenting some of that data. This publication is based on one of our six Phase 2 studies completed prior to startup of our global Phase 3 program. The clinical journal of the American Society of Nephrology recently published a paper on the results from our Phase 2b study of roxadustat for treatment of anemia in CKD patients who are not receiving dialysis. In this study, a 145 anemic CKD patients were treated roxadustat for upto 24 weeks. In the six cohorts of this study, we tested various starting doses, dose adjustment strategies and dosing frequency, three times, twice and once weekly. Roxadustat achieved an overall hemoglobin response rate of 92% across the study using the various dosing regiments. These data help inform our selection of doses for the Phase 3 program. Among the results published are data showing roxadustat's potential to correct anemia in the presence of inflammation. In the study roxadustat corrected hemoglobin to a similar extent in CKD patients with those normal and dose with elevated baseline levels of C-reactive protein or CRP which is a measure of inflammation. This result suggests that roxadustat has the potential to being used in treating anemia of inflammation which can occur in association with multiple autoimmune diseases and other illnesses outside of CKD. Additional study result show roxadustat corrected hemoglobin irrespective of iron status at baseline and without the use of IV-iron which was prohibited during the study. Consistent with those results the study also show roxadustat led to a significant reduction in hepcidin levels. Reduction of hepcidin level with result in release of iron from body storage and increased absorption of iron from the gut for making red blood cells. The data also show a significant reduction of total cholesterol with effect that was storable throughout the treatment period. This added affect may help address one of the key cardiovascular risk factors in CKD patients. And finally the safety profile in the study was consistent with background CKD, there was no safety concerns. Thank you. And I will now hand this back to Tom.

Thank you, Peony. I would like to ask Chris Chung, our Vice President of China operations to provide some comments regarding loss preparation for roxadustat and CKD anemia in China.

Thanks Tom for inviting me to this telecom. Let me introduce myself, I'm responsible for FibroGen's operations in China. With full enrollment of Phase 3 insight, I will address the March preparation work that has been initiated. FibroGen has established a 40,000 square feet facility in Beijing. It has been certified as a GMP plant by the Chinese FDA and the majority of our approximately 60 staff in China is employed in manufacturing related positions. We completed the NDA registration campaigns for API and durg product at this facility in April of 2015 and as of today we have on hand the 12 month stability data needed to support our NDA. We plan to produce commercial material and launch from this facility after securing a specific GMP license for roxadustat after NDA approval. We remain optimistic about the market prospects of roxadustat in China. The Chinese National Registry, also called the China National Renal Data System, reported that at year-end 2015 China had approximately 450,000 dialysis patients which represents a 15% year-over-year growth rate since 2011 when China first started tracking data at this national level. We expect the dialysis population to continue to grow at these in the foreseeable future. The 2015 figures represent the first deal that China surpassed U.S. levels with respect to number of patients treated on dialysis. The increasing dialysis treatment rates in China are primarily driven by improving government funded medical reimbursement coverage. Dialysis became eligible for severe disease reimbursement designation in 2013 which not only made dialysis much more affordable to patients but has allowed hospitals to invest in the expansion of dialysis facility and expand access to care. The data we have access to indicate that in large cities, 85% to 95% of total cost is reimbursed. The percent reimbursement is lower…

Thank you, Chris. I'd now like to address some more detail on our second major development program relating to treatment of fibrosis and other fiber-prolific cancers with FG-3019. Dr. Seth Porter, our Vice President of Fibrosis Therapeutics will review the ongoing clinical studies in that area.

Thank you, Tom. We will like to provide updates regarding our ongoing Phase 2 studies in idiopathic pulmonary fibrosis, Duchenne muscular dystrophy and pancreatic cancer. First in the area of IPF; as Tom mentioned, we have an ongoing Phase 2 randomized double-blind placebo-controlled study to evaluate the safety and efficacy of FG-3019 and IPF patients with mild to moderate disease. The primary efficacy endpoint for 067 has changed from baseline and force capacity and secondary endpoints include various assessments of pulmonary function as well as pulmonary fibrosis as measured by high resolution CT. We are also pursuing a sub-study in which patients will receive six months treatment with FG-3019 in combination with currently approved therapies; pirfenidone or nintedanib or one of these approved therapies alone. The study will provide needed safety data that provides a platform for further more extensive combination trials. We expect 40 to 60 patients to be enrolled this year. Turning out to pancreatic cancer, patients are eligible for our ongoing Phase 2 trial only if they have been fully evaluated for tumor resection and failed scoring for resectability, that is, have been scored as not being candidates for surgery. Subjects are randomized to receive FG-3019 in combination with standard care chemotherapy [indiscernible] or chemotherapy alone. Up until the end of last year, this study was randomized one-to-one with a target enrollment of 40 patients. The randomization scheme is also two-to-one with a target enrollment of 42 patients to provide a larger and for assessment of safety and efficacy in the combination treatment arm. Further protocol eligibility for surgical exploration is determined from specific criteria based on the plasma biomarker CA19-9, FTG PEP imaging, tumor response based on CT imaging and the NCC end criteria for resectable or board line resectable tumors. As Tom said, we continue…

Thank you, Seth. Moving on to the financials. Pat Cotroneo will now review the financial highlights for the company. Pat?

Thank you, Tom. As we announced in our press release today, total revenue for the quarter ended March 31, 2016, was $28.3 million. For the same period, operating expenses were $55.1 million and net loss was $27.8 million or $0.45 per basic and diluted share. Included in operating expenses for the quarter ended March 31, 2016, was an aggregate non-cash portion totaling $8.6 million, of which $7.3 million was a result of stock-based compensation expense. As Tom mentioned, in terms of our cash balances as of March 31, 2016, we had $309.9 million in cash as compared to $336.9 million at the end of 2015. For these purposes, cash refers to cash including restricted cash, cash equivalents, receivables and investments consisting primarily of investment grade corporate debt. On our balance sheet, the category of long-term consists entirely of investment grade corporate debt with remaining maturities of 2.5 years or less. We note that we expect to receive another contractual non-contingent payment from AstraZeneca of $62 million in the second quarter. This will complete the $402 million of non-contingent license payments under the 2013 collaboration agreement. For the quarter ended March 31, 2016, revenue increased 74% and research and development expenses decreased 14% as compared to the same period last year. Largely due to the fact that we had reached the 50-50 spending cap with AstraZeneca during the fourth quarter of 2015 on our initial funding obligations for roxadustat. In particular, the first quarter of 2016 was the first full quarter in which we no longer shared 50% of the development cost compared to the prior periods. As Astellas and AstraZeneca are now responsible for funding future development and commercialization cost for roxadustat and CKD through launch for all territories, excluding China in which AstraZeneca pays 50% of development costs. Looking to 2016 as Tom mentioned, we anticipate total cash at year-end to be in access of $310 million. I will now turn the call back over to Tom.

Thank you, Pat. I'd like to take this moment to comment on some recent transitions in the company. As many of you Dr. Frank Valone has stepped down as Chief Medical Officer. Frank is reducing his role to part-time status and he will continue to oversee the China CKD anemia program through the submission of our NDA. We thank Frank for his leadership and consider ourselves fortunate to have benefited from his guidance over the years at CMO. We are pleased to continue to benefit from his expertise as he transitions to a more limited role as Senior Fellow. I'm also pleased to announced that Dr. Peony Yu who has served the company for 8 years as Vice President of Clinical Development, and who has led the global anemia program into Phase 3 has been appointed Chief Medical Officer. Her acceptance of this position ensures continuity and allows us to focus on continued progress as we advance multiple clinical programs in parallel. Thank you, Frank and thank you, Peony for your past and ongoing contributions to FibroGen. We are now ready to start the question-and-answer session.

[Operator Instructions] And we have a question from Michael Yee from RBC Capital Markets. Please go ahead.

Tom, two questions. One on roxadustat, I appreciate the update. On the cardiovascular safety analysis, I know that's an important part of the whole program. Can you just talk a little bit about the event rates, how that's proceeding? How that plays a role into unblinding the study and the timing of all of that and talk about the event rates, is that in-line with your expectations? And then on 3019, you announced some updated data, talk a little bit about that have you talked the FDA since the initial January data? Give us an update on discussions with the FDA. Thanks.

Thank you, Michael, nice to hear from you. So let me do this -- for the CV safety and roxadustat, let me have Peony address this question. And then I will take on the second question about 3019. Peony?

Yes, Mike, as you know our U.S. global program is the event driven program. The event rate are being collected from across our studies and our partner study that includes three studies being run by FibroGen, few studies by AstraZeneca and studies by Astellas. And these events have certain tricker terms that goes to the committee. We have been planning to get together with our partners to discuss the event rate for clinical optimization in the second half of this year and at that time we will be able to provide a more accurate timing on our submission date. Based on what we are seeing today, we believe that we are still on-track for filling NDA in 2018.

Thank you, Peony. So Michael with respect to FG-3019 and the pancreatic program, which I think is what your questions aimed at, we have not yet talked to FDA. We did have the clinical lead site come down and see us last week, Dr. Vincent Prakozi [ph] at Virginia Mason in Seattle. And as a way of getting one's arms around this, I asked him what does Virginia Mason -- the docs, this is the largest pancreatic site in the West Coast, and so I asked what do they see here, and what's off note. So we talked about the resection rate change and the idea that 3019 arm and all the patients on drug are still alive and the control arm looks much worse and look like some sort of mortality or survivability study could be done pretty efficiently. But then he sort of surprised me with one other statement, he said that Virginia Mason, the one thing that has caused a great deal of focus and interest in this program is that of the 9 patients on 3019, we haven't seen what we normally see and at this moment people are pretty amazed and what we refers to is that in this patient population you would expect about 20% of the patients to die within two months and you would expect 40% to 45% or something like that to have progressed. And so on our study, we haven't heard any deaths yet and 9 patients, that's sort of what he is talking about but yes, he is also saying there hasn't been any clinical progression judgment. There is one patient that had jimsar [ph] toxicity that was taken out of study and then four months later after being off 3019 for that time. Had a findings of nuts…

Michael, your line is still open. Thank you. Our next question is from Terence Flynn from Goldman, Sachs. Please go ahead.

Hi, this is Cameron [ph] on for Terence. Thank you for taking the questions. Couple of questions, first on 3019 and pancreatic, can you tell us how many patients are enrolled and why you do is a reasonable number prior to having a meeting with regulators? And then on second, on roxa, you mentioned MDS in China, can you tell us anything more about these efforts and when we might expect some initial data? Thanks.

Okay. So, Seth you want to go over the enrollment on 3019 pancreatic and then Peony, the MDS in China.

Sure. So with regard to the 069 state in pancreatic cancer, we have a total of 16 rolled, 6 in the 3019 plus standard care and 7 in the standard care alone. Of the 9 -- actually 3019 plus standard care, 3 remain on treatment. And the remaining 6 have been evaluated. And then for the standard care alone, all 7 have been evaluated. So that's what we have today, then we are continuing to enroll that study.

Thank you, Seth. Peony, MDS in China, some details please?

Yes, thank you for asking. We are very excited about submitting and are having -- and expecting that our CTA be accepted by the Chinese government in second quarter of this year. And so we are very fortunate to be doing this as a venture 1.1 and this is being consider as if this is Chinese domestic drug. Now however, in China it does take about a year for CFDA to view and approve before we can start the trial, we plan so looking forward that will be around second quarter of 2017 and -- now this is going to be a placebo-controlled trial in the patients with MDS who tend to be very anemic. In China there is known to have severe blood shortage. The treatment guideline for transfusion threshold is hemoglobin 6 or lower. And in contrast, in the U.S. it's hemoglobin 9. So you can imagine how much a medical need there is. And the opportunity to address this unmet medical need was very much encouraged by the key opinion leaders as well as the regulators and welcome by the patients. And we have -- so this is going to be because of our lack of a pooled treatment we have the opportunity to conduct a placebo-controlled trial there.

Thank you, Peony. Next question please?

Our next question comes from Seamus Fernandez from Leerink. Please go ahead.

Great, thanks so much. Can you guys hear me, okay?

Yes, how are you Seamus?

I'm very well. Thanks for taking my question. So the first one, just as we think about the even rates, Peony, you mentioned that the even rates as come-in will be evaluated by you and your partners, sometime, I guess in the months ahead. How should we think about if the event rates were to come in below expectations, what are the corrections that could be taken or achieved to keep the event rates moving forward in a timely fashion? The second question is, with regard to the data that's available, the understanding as we have it is that the patients most likely to be affected with higher event rates are those that have the highest EPO sort of treatment exposure. So basically those that are receiving the highest doses of EPO [ph], is there any way to sort of over recruit the studies or to sort of select those patients who maybe resistance to EPO such that you're more likely to see an impact in that regard. And then Tom my last question was for you, with regard to 3019, I know you said in the past that you see a significant number of potential indications for CTGF. If you were to partner the compound, can you just give us a little bit of perspective on what you see as the opportunity for 3019? Thanks.

Okay, let me do this in reverse order and let me start with the 3019 part. In looking at partnering activity, conceptually you have very, very broad platform because this address is all forms of fibrosis with natural or cost by surgery or by poisons or whatever. And so most of the categories there is very little in therapy, there is no proven anti-fibrotic therapy at all. And so this is a great opportunity in terms of value creation. It's a complicated opportunity from a partnering point of view because most of the pharma companies in the past have looked at this and said well, we'd like to do one indication and then of course we have to have control over everything, so we want to absolute license of all indications and all decide later what to do and we've said no to that proposition probably three dozen times over the past 10 years because we aren't about that at all. The idea that has got traction in recent years are people that have proposed geographics -- so for example, Japan and Europe, for the partner and U.S. and China for us, and some agreement to specific protocol development like four or five indications that are fully funded. And truth be known right about the time we did our IPO, we were looking at a proposal like that which went away largely because of the amount of time that the IPO took. There are some changes in the management of the counterpart company and as usual with these partnering things, it's very unique opportunity to guess it's all got to be just right. And so this opportunity passed but in the meantime, as we generate more data and I'll get back to why this isn't just a set put as…

Yes, so Tom said we are enrolling very well, both in the dialysis and in the non-dialysis we are making -- we have made very solid progress and you asked a question about the event rate were different than the original assumption then what do you do? Well, the answer is that in order to achieve the target number of events, one would have had to make some -- do some of the fine titration of patient number and/or treatment duration. Given roxadustat being a high priority Phase 3 project in all three companies, FibroGen, AstraZeneca, and Astellas, and our commitment to get this study done targeting approval of roxadustat we are in a quite good place to make any titration needed because we collectively don't have -- we have more than just one clinical trial team. We have more than two, actually we have three and we are enrolling from over thousand study sites around the world. So we have the capability to make any titrations needed. What we need to do is to get together and compare numbers to refine the timing. I hope that answers your question?

Seamus, are those good answers for you or do you want to follow-up?

And now we have a question from Kennen MacKay from Credit Suisse. Please go ahead.

Hi, this is Sonic Alex [ph] calling in for Kennen. Thanks for taking the questions and congrats on the progress. First quick question regarding the 063 study, the incident dialysis trial I believe. Could you put a light a little bit more color on why the focus on U.S. enrollment?

Okay, that's a pretty simple one. So I can do it pretty quickly. Our there in the dialysis world, the U.S. is unique because the U.S. ESRD Medicare system essentially pays all the cost for dialysis when you cut through all the different insurance programs, so long they are available. And so as a program that's fully funded by the government, there are some things that have happened that are different than other countries. And in particular, in the U.S. there are no restrictions on the use of EPO because of the paid portfolio by the program which is being known as the ESRD program. And similarly with IV-iron and so in the U.S. you have patient cohorts that arguably would not even be on therapy because they wouldn't be alive in other countries and these are people that have chronic inflammatory conditions and require very large amounts of EPO and very large amounts of IV-iron to maintain hemoglobin levels. And so we've seen -- actually in our slide deck if you look, there is 2012 database from the dialysis program, this is after the bundling and after the FDA package research changes. And you can see that the uses of EPO is much higher in the two quartiles or the big consumers versus other patients. And those are the inflammation hyper response sub-categories. As I said, this is not something that's seen elsewhere other countries have not been willing to accept the cost of EPO without restriction. So for example in China, we see volume caps that have been instituted by the government that really prohibit the use of EPO above 2x package insert and that's a typical sort of tie-up, costing mechanism. There are various kinds that are used in other countries and I think most -- everyone…

And our next question is from Tom Shredder [ph] from Stifel. Please go ahead.

Good afternoon, congratulations, really seems like things are cruising along. A lot of the questions have been asked. I have a couple of little ones, in kidney cancer I think it's probably reasonable that if you have resectible cancer, you're better off and if you don't. How strong is the medical data that if you get to being resectable via chemo your chances are better, and really what I'm asking is, is this an obvious candidate for accelerated approval or is there work to be done here?

Did you mean kidney cancer or did you mean pancreatic cancer?

I'm sorry, pancreatic cancer. My apologies.

So let me make sure and frame the question. Seth, you want to try to take this one off?

Sure. So I think you're asking how much background information is there if you treat patients with unresectable pancreatic cancer to convert them with chemo. And frankly, there has been a lot of work done on that, it's becoming an area of great interest over the last few years but there isn't a lot of data on that. And where there is focus on -- people tend to focus on those who are borderline resectible, our trial is relatively unique and that we're looking at patients who are deemed to be unresectable and seeing if we can convert them to resectability.

In addition there, we have had various key opinion leaders give us advice and they have described circumstances in which patients have been resected like this and this occurs because in the standard of care arm 5% to 10% of the patients will be eligible for resection after six months of therapy. And what they have found, this is anecdotal is that the same basic survival rates apply which is to say in the overall system, something like 15% to 20% chance of survival at 5 years. And with best care, for example, I've heard this from Virginia Mason last week, with best care it would be at 40%, 5 year survival. And the expectation when somebody has failed resection scoring initially, they don't get a whipple immediately but instead they are sort of in this twilight zone. It is about 1%, it is 1% to 1.5% survival at 5 years. Again, according to the Virginia Mason key opinion leaders that were here last week. And so that's a rough field for the numbers, the key punch line here is that's an awful lot of clinical benefit whether it's 20% survival or 40% survival with 5 years compared to 1% or 2% survival with 5 years. And so that's the other way to look at it.

All right, perfect. And then it looks like in the incident dialysis trial, you're allowing patients in who've seen a little bit of ESA now, it's a recent change. Is that just medical reality that a lot of patients have seen some level of ESA before they get to dialysis?

This is a very good question, very perceptive. So I think Peony, I think you can explain the rational for why we're doing, what we're doing in the amendment that allows [ph]?

Exactly, very good that you picked this up. So what we have found is that when we try to enroll incident dialysis, patients in the U.S.; some of the patients who really are treatment naïve until they were hospitalized and their consulting nephrologists gave them a shot of EPO. Then they go to the dialysis center and then an investigator will tell us what this patient is no longer eligible for your study even though they are still anemic and this is the rational for changing that patient selection criteria to include this kind of patients.

So two defaults. These patients in that kind of emergency wards first, the incident dialysis. I think in the U.S. system it's acknowledged that 45% of the entries are emergency cases. And the immediate treatment standard of care when their disorders are recognized because a lot of cases that are undiagnosed, just to give a EPO [ph]. But it's only given one or two shots before they are in a position to be in the trial. And so once we've realized this, that the physicians are very frustrating because it's turning down candidates that are otherwise ideal. We said we don't really care if the patients have one or two shots of EPO because you're going to need two or three weeks of therapy with EPO to get hemoglobin changed. So the real issue is do we see any movement in hemoglobin and if you don't why not amendment of the study. And so that's been the rational, and that sales why we made the change, and thank you for asking the question.

Okay, perfect. Thank you very much.

We have no further questions at this time. I would like to turn the call over to Tom Neff for closing remarks.

Thanks to everybody on the line today for participating in our call. We look forward to speaking with you again soon and proving future updates next quarter.