MY (Michael Yee, Jefferies) TN (Thomas B. Neff, FibroGen) PY (K. Peony Yu, FibroGen) SP (Seth Porter, FibroGen) MY: Thank you for joining us for this afternoon session. Michael Yee, Managing Director and Senior Biotechno

MY (Michael Yee, Jefferies)

TN (Thomas B. Neff, FibroGen)

PY (K. Peony Yu, FibroGen)

SP (Seth Porter, FibroGen)

MY: Thank you for joining us for this afternoon session. Michael Yee, Managing Director and Senior Biotechnology Analyst here at Jefferies, and really happy

to have one of the companies that I cover up here, FibroGen. With us on the podium to my left here is the Chief Medical Officer, Peony Yu. In the middle is the founder, chairman, and CEO, Tom Neff, and to his right is VP of Fibrosis Therapeutics,

And there is not a breakout session, but I ll ask all the good questions.

I guess I just wanted to start off Tom, maybe open it up to you. Obviously, this is perhaps the most transformative year in Fibro- potential

most transformative year for FibroGen. Maybe you could talk about your two programs and specifically this year what are we going to get from roxa? And what are you looking for, and what s good data from roxa this year?

TN: OK. So roxadustat is at a stage where we are closing 15 Phase 3 studies around the world I think we ve just gotten to number eight being

closed. Approvals are slated for China, Japan, European Authority on the continent, and U.S. The Chinese and Japanese studies are not involving MACE cardiovascular evaluations, and China will is ahead of the others now, so we expect China and

then Japan, and then the filing for the MACE pools will affect both the U.S. and Europe, so the so the contemporaneous filings for Astellas which is the license holder in Europe and FibroGen in the U.S. with AstraZeneca, and so you know best

case, we will have in China an approval for dialysis CKD and non-dialysis CKD, in Japan in dialysis CKD the non-dialysis is one year out and then in Europe

it s a MACE+ endpoint, so it s a MACE evaluation, cardiovascular MACE but a MACE+ endpoint, and Astellas will be on the basic calendar that we committed to in the U.S., which is to say, in the

4th quarter we expect to have individual studies read out, and, as soon as those studies are all read out, we will bring together the non-dialysis pooling

and the dialysis pooling, which are the two big reportable outcomes for U.S. and Europe, and we ve given ourselves part of next year to get that done. Internal goal is three months [for] our partners so that would mean, like, March, but I think

we ve said mid-year for full filing just to be careful about the timing. So we expect individual studies to readout in November-December and from there the others, and so that s the picture in

MY: And so my point is that investors are certainly keenly looking forward to the efficacy data in November-December, I think you implied.

What is a good outcome non-inferiority in dialysis on efficacy, superiority on efficacy like in non-dialysis, what s a good outcome?

TN: Let me ask Peony to take that one on.

expect, Peony? What s good data?

PY: OK, so we are so when we look at non-dialysis, we are comparing

against placebo; we fully expect to be able to demonstrate superiority in the three U.S./EU global studies totaling 4300 patients. And I m I have that confidence because we ve seen this drug work, work very well, in non-dialysis in China with 150 patients, we have 14 zeros in the p-value. And in terms of efficacy, in dialysis, we also have full confidence this drug will work well based on

the extensive Phase 2 data as well as China dialysis study where we the criteria for meeting efficacy was just to show non-inferiority and we ended up demonstrating superiority, especially in the

patients with inflammation measured by elevated

C-reactive protein. So we expect that in the global program there will be patients on dialysis with inflammation and we expect that to occur in about 30% of the patients, and that is where we

will have most advantage over EPO but at the same time, our regulatory hurdle is to show non-inferiority in change in hemoglobin from baseline in comparison to EPO in these Phase 3 studies.

MY: So in dialysis, non-inferiority to EPO, it certainly means you re least as good as it, as an oral pill?

non-dialysis against placebo, you would certainly expect superiority with lots of zeroes on it. So after we get efficacy, I know Tom you suggested it would take some time to pull together all of the data for a

MACE analysis because you want to show that the drug is not going to cause worst cardiovascular side-effects than EPO or placebo, can you talk to what you would expect in the MACE analysis a few months after the efficacy analysis in

November-December so, in spring? Do you expect non-inferiority in MACE and non-inferiority in dialysis/MACE do you expect

non-inferiority and that s a good result?

TN: So I think the way to answer this question is that ...

let s just go through each of non-dialysis and dialysis and think about what s happening. We have studies in the U.S. that will be combined with the study in Europe it s Astellas s

study, their 608 study and we would expect that in the MACE filings that we would have numerical advantage in MACE in the non-dialysis setting; that s certainly the goal for how we ve been

thinking about it. And of course the MACE is really a safety readout in many ways and so I ll just stick to that here. In dialysis there s two different pools: one is ESA switch which is to say how ESAs been used previously in dialysis for

the past fifteen years, and that population are people that are on dialysis coming into the study and they are randomized either to more EPO or roxadustat, 1:1. And then in the population of incident dialysis patients this is part of our

effort to address a fundamental unmet medical need in dialysis. So CMS informed us a few years ago that their analysis indicated that they felt 30 to 40% of patients did not have adequate standard of care with current medicines and as such

particularly in inflammation, so in inflammation typically EPO studies don t work and roxa does work without modification or increased dose. So in that kind of environment if the results bear out, they re willing to talk to us

outside the bundle, OK? And so that incident pool s about 1500 patients and will be done by FibroGen and AstraZeneca for U.S. filing. It s not a key issue in Europe, but it s a very key issue in the U.S., and, of course, as it relates

to reimbursement, one of the things they ll want to see is that the patients that are in the incident pool were properly handled and you know had incremental benefit as expected so that they can believe that there is not a need for EPO to be

used first in that population. So you are essentially trying to segue into first-line therapy in the EPO hyporesponse population, and so that s the other comparison that will be done as part of the reporting, so . Now that comparison, I

need to make clear, that the shell of all of EPO includes the incidents incident is a subgroup of the dialysis pool. But that s the strategy.

MY: So in non-dialysis again on MACE, non-inferiority with a potential

positive trend, I presume that your drug has a positive effect on cardiovascular so this would be at safety with a numerical trend .

again, I think what I can share is what we can that this is a very innovative medicine it turns on the body s machinery to make hemoglobin go up so there s a lot of things that happen coordinately. And, so, we have believed

for a long time that our compound is really a hepcidin regulator, and when we started talking about this, hepcidin had barely been discovered, but it was soon shown that, with hepcidin that this is 2005, approximately that hepcidin was

upregulated in conditions of inflammation and it served to block the channels through which red blood cells are made. So an absolute bar to production of red blood cells. And so with CMS, we actually briefed our compound as a hepcidin regulator.

That allows them to look at it as new technology, because EPO doesn t do anything like this.

And so this kind of approach is something that we ve thought about a lot, and all the data we ve gotten

so far we looked very carefully at what s going on to support what we think is going to happen, which is to say that we think that were going to find that the slope of eGFR will shift on treatment compared to placebo, and to us that s part

and parcel of having positive MACE numbers, so that s how we re thinking about it.

MY: OK, so lowering hepcidin, lower in inflammation, novel

mechanism that you think the FDA would view as potentially novel enough to be outside the bundle that s what you have said?

FDA, CMS. CMS, yeah. So, at FDA, they re going to look at normal standards for safety and efficacy for approval, but what we re interested in as it relates to CMS is, do you see benefit here incrementally for the patients that do not have

adequate standard of care now? And, if you do, are you willing to engage in the normal kinds of things CMS is empowered to do to encourage new technology, which is to say that we wouldn t be put into the bundle and be second-line therapy to

MY: Yes. OK, and then one last question on EPO and then I m going to ask some fibrosis questions. Either for Peony or for Tom, there s

been a lot of growing interest in a number of public stocks that have Chinese approvals coming, some of them have large market caps, you have I think a program that could get approved in China, you did say later this year, for roxa, not a lot of

investors seem to talk about it. You know, what is the type of peak sales you think could be doable in China for roxa and, you know, what do you think could happen there?

TN: OK, so I think the easiest way to get at this: in China, it s a very different kind of market for anemia because, unlike in the West, China really

can t use blood transfusion as a chronic therapy method. Because of the degree of contamination that exists from Hepatitis B and C. And so when discussing with the regulators, we re really talking about areas in which EPO itself the

recombinant protein or the knock-offs were not approved, essentially stopped in 2008 after the safety events in the U.S. And, so, if it s not approved with EPO, there s no requirement for us to use to have to use transfusion

in the control arm, so from the perspective of how we and many people in China look at this, we are bringing a solution to a very challenging problem, which is to say with an EPO you have to have cold storage system, you have to have sterility and

so on, and you have to figure out how to reimburse very poor people s usage of EPO or it s an expensive drug, and so we are approaching it with an oral therapy, we have a lot of these problems go away, and we expect that use will go

throughout society. We are keeping pricing in a range which is considered very reasonable in China and it s a little bit of an explanation as to why we can do that, but there s there are reasons, solid medical reasons that we are

approaching it this way. And so the goal or the vision is really to have a brand as more that, a brand than an agent more like a brand because we re able to do several things at once again in patients with high

inflammation, it works where EPO doesn t, in dialysis or in non-dialysis settings in nephrology we can treat anyone and everyone, and so on. So it s very exciting in China.

MY: And you ve gone to China, there s actually articles all over the web, on engaging with the regulators and the government, and you ve had

pretty high level conversations with them.

TN: Yes, and I ll have Peony here share a little bit of what she s seen about the business in China,

she s in a position that she converses routinely in Cantonese or Mandarin, which I can t do

MY: So, Peony, just anecdotally, you ve

been to Asia and talked with regulators and the government about this and what do they say?

PY: Well, there has been a great deal of interest from the

regulator and the physician. Both, as Tom said, this is a public problem that we are trying to solve. In the U.S., if you from surgery or any reason, if my

patient needs a couple units of blood, all I need to do is I put it on the doctor s orders and I know it will be done, In China, it s not the same, there is shortage in the blood bank

and physicians have to apply for blood. The threshold for transfusion in the ... for example, for chemotherapy-induced anemia or MDS, patients hemoglobin [inaudible] which is half of , less than half of the hemoglobin level of you sitting in

the audience. So an agent, an oral agent which can increase the hemoglobin level, is very attractive for the Chinese patients.

MY: So we ll look to

formal guidance is by the end of the year, is that the formal guidance on potential approval I don t think there s like a PDUFA filing?

TN: Yeah, I don t think sales numbers have been put out there just because there s so many variables in play thus far, but I think that, you know

numbers anywhere from three-quarters of a billion to a couple billion dollar, I ve seen as a range of numbers.

MY: OK. I need to check my

model I need to check my model.

TN: And the number of users in China is a quite a bit larger than the number of users in the U.S., so in

currently, in China, the dialysis count for the patients that are doing not transplant but just dialysis is about 50% higher than in the U.S. they surpassed the U.S. about three years ago and it looks like they re going to go to about a-million-and-a-half, the U.S. is about 400,000, so you re talking about much bigger

markets and so as this stuff plays out there are some really interesting dynamics in terms of value creation.

MY: OK. So we ll look to that, and

also we ll look forward to the global Phase 3 efficacy studies readouts in November-December, and then the MACE shortly thereafter, so that s going to be really important.

In the meantime, Seth, there s been a great deal of attention because you ve had a lot of data now on your second drug, pamrevlumab, the fibrosis

antibody, both in IPF as well as the data this weekend at ASCO in locally advanced pancreatic cancer. Maybe I guess briefly talk about some of the initial data from IPF and pancreatic cancer and what the next steps are for those programs because

there s been a lot of data and you re going to move forward with this.

SP: I will try to summarize this briefly. So, we reported out the

results from our Phase 2b randomized controlled IPF trial last year, and we continue to report out data because there s a lot of data that has come out of the study. So, we showed a very robust effect in terms of pulmonary function and slowing

down the rate of pulmonary function measured as FVC or FVC % predicted. And, also, in terms of disease progression, that is those patients that have a decline in their FVC % predicted of 10 % or more or death, so that s a very real measure

of disease progression, and so we showed a very strong signal in terms of improvement over placebo on that. And then just recently, a few weeks ago, at the American Thoracic Society meeting, we reported out results from our assessments of

quantitative fibrosis, and we have been unique in that we used that assessment in both our first Phase 2 open-label study and then again in our randomized Phase 2 study, and we have shown by quantitative high resolution CT imaging a statistically

significant slowing down of the rate of fibrosis compared to placebo. And we are, as far as I know, the only company who has been able to show that effect on fibrosis and as expected but never shown by others that the changes in fibrosis relate

directly to the changes in pulmonary function so that makes sense biologically and I think we are unique in showing that effect. And, in addition, we also reported out a few weeks ago in terms of patient-reported outcomes the so-called St

George s respiratory questionnaire, which is an assessment of quality of life in pulmonary patients and there, too, we saw a strong trend in our Phase 2 study in terms of patients who are feeling better, functioning better for those treated