Welcome to the Quarter Two 2016 FibroGen, Inc. Earnings Conference Call. My name is Katie, 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. I will now like to turn the call over to Jennifer Williams. Please go ahead.

Thank you, Katie. 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 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 Form 10-Q for the quarterly period ended March 31, 2016 and our Form 10-Q for the quarterly period ended June 30, 2016 filed with the Securities and Exchange Commission, copies of which 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. A webcast of this conference call will be available for replay on the Investors 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. I hope you’re enjoying your summer. On today’s call we will provide updates on our programs, discuss recent accomplishments and highlight key near-term and long-term goals. Joining me for this discussion are Mr. Pat Cotroneo, Chief Financial Officer; Dr. Peony Yu, Chief Medical Officer; Dr. Seth Porter, Vice President of Fibrosis Therapeutics. In addition, Ms. Chris Chung, Vice President of China operations is also present to answer any questions for China that may come up during the period following the scripted portion of the call. Let me start with an update regarding our Phase 3 anemia program. Our roxadustat global clinical program features four independent regulatory pathways; U.S., Europe, China and Japan. We and our partners have not advanced to Phase 3 in each of these jurisdictions and are conducting various Phase 3 studies that are well supported by extensive Phase 2 data showing roxadustat correction and maintenance of hemoglobin levels in multiple subpopulations of CKD. With the addition of the Japan Phase 3 studies at some point this fall, we and our partners will have 15 studies open in Phase 3 for roxadustat targeting approval in all four major regulatory regions around the globe. For the studies in the U.S. with AstraZeneca and for our studies in China, we remain on track to initiate a new drug application submissions in 2016 for China and 2018 for the United States. In the U.S. program, FibroGen is responsible for three studies and agreed with AstraZeneca as to target enrollments for each of our studies. We previously announced that we have met these target enrollments in two of the three; study 064 last September in dialysis conversion, study 060 February this year in CKD non-dialysis patients. With respect to 060, we continue to enroll patients…

Thank you, Tom. Before addressing Japan, I’d like to comment on the status of our global Phase 3 program. We and our co-development partners continue to enroll patients from over 1,000 study sites in 50 countries into roxadustat U.S. and EU global studies. As we continue to advance to Phase 3, we’ve identified some adjustments appropriate to optimize the overall program. We previously announced achievement of target enrollment goal of 600 in our CKD non-dialysis study, study 060. We are now expanding this study by adding 300 extra patients to meet the overall enrollment goals among our partners. We intend to meet this additional enrollment goal by the end of this year. We are on track to meet the initial target enrollment of 750 in the 063 incident dialysis study by Q3 2016. We are also expanding this study by adding 150 extra patients in order to maximize incident dialysis patients in the U.S. Next, I would like to highlight the progress our partner Astellas has made in the development of roxadustat in Japan. We recently issued a joint press release announcing the start of Phase 3 in Japan and presenting data from Japanese Phase 2 studies, which represents the first new roxadustat study data since our IPO. In the 107 patients double-blind, placebo-controlled non-dialysis study, those response was demonstrated for the three different starting doses over the first six weeks of treatment. Over the full course of the 24-week study, a 93.8% hemoglobin response rate was achieved in roxadustat treated patients versus a 14.8% response rate in placebo patients. Roxadustat dose response was also demonstrated in the Japan Phase 2 study in dialysis patients. Astellas has met with PMDA and gained alignment on a Phase 3 plan that includes six studies, which includes four in dialysis and two in non-dialysis. Three of the four dialysis studies are already underway and the rest of the studies are under preparation. The Japan Phase 3 program will cover a broad range of patients, including patients not on dialysis, patients on hemodialysis and patients on peritoneal dialysis. These studies are designed to show anemia correction in treatment-naïve patients as well as conversion and hemoglobin maintenance in patients who were previously treated with ESA. Thank you. I will now hand this back to Tom.

Thank you, Peony. I would like to ask Dr. Seth Porter, our Vice President of Fibrosis Therapeutics to expand briefly on 028 study and the proposed publication mentioned early in this call. We hear and received questions from some of our longest standing institutional holders regarding our rationale for study 069 study design and we have heard that the background information was helpful. So I’d ask Seth to cover such data comprising human studies in the past as well as certain enlightening results in the rodent models with pancreatic cancer. Seth?

Thank you, Tom. I’d like to give some additional perspective regarding our pancreatic cancer program. The take home message is that in a completed study of FG-3019 in largely metastatic pancreatic cancer, study 028, and now on an ongoing study of locally advanced pancreatic cancer, study 069, we are observing indications of substantial benefit of FG-3019 therapy based on clear objectives and quantitative criteria. In the current study 069, enrollment is restricted to patients with locally advanced pancreatic tumors scored as unresectable, which patients are normally assigned to a six-month standard of care regimen. In 069, we compare that standard of care regimen to standard of care plus FG-3019. After six months of treatment, eligibility for rescoring is determined by evaluating treatment response against specific objective criteria. Improvements in tumor response is quantified by CT scan, decrease in biomarker CA19.9 and decrease in PET imaging. Although we’ve observed improved scores against two out of three of these measures if and only if patients have met one of these objective criteria can they be evaluated by the site surgeon to determine eligibility for resection. We want to point out the development of these advancement criteria derives largely from observations of response in a prior 028 study. As Tom mentioned, we have submitted a manuscript describing study 028 for peer review and I’ll briefly touch on the highlights of that study. As presented in part at the 2014 ASCO-GI meeting, study 028 was an open labeled dose escalation Phase 2 trial in patients with locally advanced stage-three or metastatic stage-four pancreatic cancer. Most of these 75 patients were in fact metastatic, only nine had locally advanced disease. FG-3019 was evaluated in combination with gemcitabine and erlotinib as first-line therapy. A key important observation in the 028 study was that once doses were…

Thank you, Seth. Moving on to a discussion of our financial position, our Chief Financial Officer, Mr. Pat Cotroneo will now review the financial highlights for the company. Pat?

Thank you, Tom. As announced in our press release today, total revenue for the quarter ended June 30, 2016 was $89.3 million. For the same period, operating expenses were $62.8 million and net income was $24.3 million or $0.39 per basic share and $0.35 per diluted share. Included in operating expenses for the quarter ended June 30, 2016 was an aggregate non-cash portion totaling $10.8 million of which $8.4 million was a result of stock-based compensation expense. As Tom mentioned, in terms of our cash balances as of June 30, 2016, we had $368.6 million in cash as compared to $336.9 million at the end of 2015. We confirm our expectation of year-end cash to exceed $310 million. 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 investments consists entirely of investment grade corporate debt with remaining maturities of two years or less. During the quarter, we received a scheduled $62 million license payment from AstraZeneca. This has completed $202 million of non-contingent license payments under the 2013 collaboration agreement. As Tom mentioned, we also received a $10 million milestone payment from Astellas in July, which is included in second quarter financial results. I will now turn the call back over to Tom.

Thank you, Pat. We are now ready to start the question-and-answer session.

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

Hi. This is Andrew Tsai on for Michael Yee. Thanks for taking my question. Could you please remind us the timing of completion of enrollment, specifically for your partner’s Phase 3 programs? I think you mentioned but I didn’t catch that precisely. And when exactly would data occur in 2017? Are you prepared to give guidance by the start of next year? And last, do you have an estimate for the time of data based on estimating event rates? Thanks.

Okay, Andrew. So I think I understand your questions, so let me try to take it on. We do not have permission from our partners to report on their progress. Each company is operating within confidentiality agreements that govern their activities. We are subject to those with respect to both Astellas and AstraZeneca. The guidance is with respect to end of studies. Similarly we don’t have the ability to provide anything. What’s the other part [ph] to this question?

The question was if we would disclose event rate, I do not believe that we have our partners’ permission to --

Thank you for reminding me. So with respect to event rates, let me say that in the first instance we have to do something called adjudication, so we’re doing studies. Event rates are happening and we have to go through an adjudication process to get them into the shape to become relevant for purposes of figuring out the point at which an event driven trial can be completed. We have not given guidance on their rates per se, that is to say the rates seen in dialysis or in non-dialysis to-date. I think that that’s probably where I should leave that question.

Our next question comes from Terence Flynn from Goldman Sachs. Please go ahead.

Hi. This is Cameron Bradshaw on for Terence. Thank you for taking my questions. Two questions from us. First of all, what is your current thinking around disclosure of these three data in China for roxadustat? And then secondly, can you help frame expectations for us for the next update of 3019 in pancreatic cancer? Thanks.

Okay. So with regard to Phase 3 in China, there are a couple of reporting events to note. Near the end of the year we will have top line efficacy and safety data and we will try to provide summary top line information at that time. We believe that the study which is a non-dialysis study will be finished and ready to report just a bit earlier than dialysis, so our timeline is really tied to the dialysis program. And the dialysis study will end right at the end of November, so the question becomes how fast can we get data locked on and so on? So we’re thinking early in January for that – we may do better but somewhere in that time period. Second, because of the desire to follow the chronic therapy regulations that ICH propagates for oral product used drugs, we are very interested in completing a safety assessment at 26 weeks and then for the single arm roxadustat patients at 52 weeks. We would expect to provide information when each of those things happens. And so the 52-week single arm portion is the last event in the Phase 3 as currently planned. And so if things go according to our plan, it would be such that that information will be available in March of next year 2017. And we probably would be able to report that out probably three months later as it relates to the overall NDA, because that will be the last part of what is needed for the NDA submission. And so somewhere June-July is what we’re thinking for that final safety assessment and obviously the 26 week is somewhere between December-January and June-July. So that’s how much we know right now and that’s what we intend to do based on current requirements in the study. With respect to pancreatic cancer, for sure there will be data reported at the ASCO-GI meeting. Depending on a variety of issues we may take time in the next call to possibly a following one to provide a summary update on that program. This call we felt that having people understand that the rescoring or resection eligibility is actually tied to objective criteria where the responses that we require are quite unusual evidencing real response to the antibody. We thought that was a real key idea to get out. So we used this call for that purpose. I can’t say for sure, we might not use next two calls for that as well. So it’s not absolutely guaranteed that every quarter we’re going to report data out of that study but we’re trying to do the best we can, given all the circumstances.

Great. Thanks.

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

Hi. This is Rich Goss calling in for Seamus. Thanks for taking my questions. I understand you can’t say too much about the event rates right now but I believe you mentioned that you have a planned meeting with Astra and Astellas later this year to discuss this. Just wondering if you can take us through when this might happen and what the possible outcomes for the meeting might be if the events are coming in slower than expected? Thanks.

Yes, so we have to have enough information about event rates in each sub-segment of the patient population to be able to project them. And so we’re sort of in the middle of that. We have pointed out that there is more focus on U.S. incident dialysis now and so you can probably infer there that that’s a portion that we need a little more in the way of observation rates. Similarly with respect to the non-dialysis study, we have mentioned before that this population’s much sicker than the one that was encountered in the TREAT study Amgen performed in 2004 to 2010, which was considered sort of the analog best practices study to look at. It’s sufficiently different that we have patients that are in span of shape that they’re entering this study just before dialysis. So it’s a little different situation than people had expected and we intend to talk to FDA about this and define what’s considered to be the adjudicated data net of any such thing as needed and any thoughts they have about the overall rate and so on in that study. So these things are happening just prior to the optimization exercise, the two things I just mentioned incident dialysis and non-dialysis very sick patients are things that are in the U.S. studies. So this is something that AstraZeneca and FibroGen have to sort out. And then with respect to the next event, the optimization, that’s a three-way activity. And in that circumstance we intend to move forward as soon as we have clear reads on items that I briefed you on today, incident dialysis and the non-dialysis low EGFR population. And so that’s the thinking. And so everybody’s very anxious to have the meeting on optimization studies and so on. Part and parcel of that meeting is Astellas has to decide if they are filing in Europe, this came up on their call last week, soon or if they’re going to want to have more data approval and that issue is still open as they noted.

Okay, great. Thank you.

Thank you, Rich.

Our next question comes from Kennen MacKay from Credit Suisse. Please go ahead.

Hi. This is Slanix Alex on for Kennen. Thanks for taking the questions and congrats on the progress. Just regarding expanding the enrollment for 060 and 063 trial, could you tell me a little bit more about which geographies you might be focusing on there in terms of the expanded enrollment?

Okay. In study 060 there’s no particular bias in geographies. There is enrollment in several parts of the world going on now. We probably will be doing more U.S. just simply because U.S. came online last, but there’s other proportions in that mix. And Latin America and Asia Pacific are places we’ve been doing for now. 063 we’ve mentioned before, I’ll say it again, there is very laser-tight focus on getting U.S. incident patients both study 002 at AstraZeneca and study 063 at FibroGen have been tasked with getting this done as fast as possible. And this is in consideration of FDA instruction back at the time of the company Affymax and the drug candidate OMONTYS, FDA indicated they wanted a population of incident dialysis patients sufficient that at least arms could be stratified statistically. So I think sort of puts the challenge out there. When we started our Phase 3 negotiations with FDA, they made it clear that that instruction also applies to us. And so we’re focused on getting that done.

Okay, great. Thank you. And second question is in regard to the IPR filing that GSK has filed earlier this year. Any updated guidance on that front? And in terms of timelines, when might we hear whether or not that the IPR has been accepted or not?

Okay. So we generally don’t make it a practice to talk about IP; however, this is a public event and so let me just make some simple points. With respect to roxadustat or FG-4592, we have valid and issued claims with respect to composition and the dates go far out into the future and none of that is affected by any of this litigation. So our freedom to operate in exclusivity on roxadustat enjoys U.S. patent protection out to 2033, for instance. There are many other patent filings that were made by us over the years, starting in 2001 that related to anemia and many of those filings have resulted in issued claims where it would be reasonable for competitors to think that they might run into one or another of these claims in the prosecution of the program. And so we’ve certainly mentioned this to everybody at the appropriate times during the IPO, roadshow and interviews with analysts and one-on-ones and so on. So we’ve made this known, right. There’s substantial amount of IP out there in favor for FibroGen. In fact, if you go to USPTO and just type in FibroGen you’ll see all the stuff. It’s pretty easy to follow. And so in this respect it doesn’t particularly surprise me GSK is doing what they’re doing. It makes sense that they have to get themselves convinced that they can advance. IPR obviously new terrain and it’s hard to predict what will happen, but we’ll figure it out and do the best we can to defend ourselves. And it’s obviously the case that we believe that all of the discovery and invention with respect to the HIF system, like recognizing the iron [indiscernible] enzymes and iron flux and so on as well as the HIF-PHI and inflammation effects. We think that we were the first in the world to document and the claims as it relates to therapeutic uses we think we’re definitely entitled to and those are examples of the things that are at issue and this kind of situation. So to recapitulate, these litigations do not have any effect on our freedom to operate with our compound and we have composition of matter claims that go far out into the future over roxadustat. Things such as HIF-PHI and the treatment of inflammation and no need for IV iron and stuff like that are discoveries that resulted in patent claims. We think we’re entitled to appropriate protection for those ideas, but this is why they have dispute mechanisms in courts to sort these things out. So we’ll see what happens as time goes on.

Sure, understood. And if I could just ask a follow-up question regarding IP. Any update on the EU patent ruling and the appeal process there?

So in the European Union there are many oppositions that are going on. These affect similar subject matter in Europe but the system’s completely different. What happened thus far in Europe was that the court decision which followed a certain set of rules that are different than EMAS patent finding and granting rules there was a finding against us which we appealed. And we are advised that that appeal will be four or five years before it is heard. During that time period, the patent at issue is still effective. So don’t take away the idea that because somebody won an opposition hearing that anything has changed and there are multiple classes or claims that are needed to be gotten through if someone expects to be competing with us in Europe. It’s not quite as clear cut as in the U.S. because in the U.S. any single infringement often times is a basis to exclude competitive molecules. In Europe, it’s more complex. But at the same time there are many other active oppositions and we are very optimistic about where these will all turn out as time goes on.

Okay, great. Thanks, Tom.

Yes, my pleasure.

Our next question comes from Tom Shrader from Stifel. Please go ahead.

Hello. This is Tahel Noy for Tom Shrader. I have a question regarding the incident dialysis patients, you definitely identified this population as the one that have the most desperate need for a new treatment approach. Do you expect that this population will be specifically identified on the future label of ESA? In addition, do you expect that most of the single arm [ph] study will be driven by this population?

So that’s a very good question and let me start by saying that with respect to incident dialysis, none of the ESA products that have been on market have done evaluations in incident dialysis. This is why FDA ordered Omontys/Affymax to do this. We concur this is the most fundamental comparison in the sickest patients. What we have learned over the past couple of years is that within the incident population there are as a subset of patients that have high degree of inflammation as measured by factors like CRP, and as a result they use much higher levels of EPO and much higher levels of IV iron. In the U.S., this is possible because under the ESRD rules that were propagated during the Nixon administration, the government essentially reimburses for all drug use in dialysis. So the U.S. is completely different than anywhere else in the world. In other places, 10 times as much EPO, it’s sort of tough luck Charlie in terms of getting reimbursement. So it doesn’t happen. But in the U.S., there’s a cohort of about 40% of the dialysis population if you look at the slides we used in the IPO period which I think are on our Web site, you can see the data and I think the citation is 2012 or '13 which was after the bundling and all the other restrictions on use that FDA propagated. And so it’s a pretty accurate picture what’s going on. We have since been informed by CMS that they view the subgroup within that pool of patients with hyper response to ESA and high inflammation, in other words HIF-PHI elevation that CMS doesn’t believe is adequate standard of care for those beneficiaries and they’ve encouraged us to take a very close look at that sub population.…

Thank you very much. Can I ask another one about the program outside of CKD? Would you need to conduct a study in each malignant indication or will some sort of a basket study or region study will be sufficient there?

Peony, you want to take that one on maybe?

Yes. So currently in China we have filed a CTA for MDS and that is a single Phase 3 study with placebo control. Now in the U.S. for the same indication MDS anemia, we have already met with the FDA in May and reached an understanding about what the Phase 3 study design needs to look like. And as Tom mentioned, we plan to provide more update when it becomes available. As for chemotherapy-induced anemia there is a great deal of unmet medical need both in U.S. and in China as well as in the rest of the world, particularly in China where there is no chronic transfusion available. The treatment guideline for patients who have intractable anemia is considered transfusion when hemoglobin is below hemoglobin 6. So these patients are very short of oxygenation to their organ tissues. Now under the setting, we have discussions with Chinese CFDA who are in strong support of us pursuing this indication. The prior approval for CIA in China were based on one study that consist of multiple cancer types. We are in discussions with the CFDA regarding the requirement for our study at which approach to take. Does that answer your question?

Yes. Thank you very much.

Our last question comes from Joel Beatty from Citi. Please go ahead.

Hi. Thanks for taking the questions. So for the Phase 3 non-dialysis dependent studies, what happens to some patients in those studies that become dialysis dependent and how are they analyzed?

That’s a good question. Patients that enroll with low GFRs will proceed to dialysis during the term of a one or two or three-year study. That’s normal. We have continued to treat them in dialysis, and such that’s a subset of patients that are pretty unique. This is turning into a pretty large first-in-class study in a lot of respect and this is certainly one of them – one of the issues that we’re looking to get some guidance from agency about is how they will admit those patients. But in our studies the concept is that they stay on study whether they’re given drug or placebo because it’s blinded, so we have no idea who’s getting what, right, but the protocol assumes that people stay on drug in dialysis.

Okay. Thank you.

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

Thank you. Thanks to everyone on the line today for participating in our call. We look forward to speaking with you again and proving future updates. Thank you for your time today. Have a good summer.

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