FibroGen, Inc.
Q2 2017 Earnings Call Transcript

Published: 8 Aug 2017

[Operator:]

Welcome to the FibroGen, Incs. Second Quarter 2017 Financial Results Conference Call. My name is Ellie and I'll be your operator for today. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] Please note that this conference is being recorded. A webcast of this call will be available on the company website for two weeks from today’s date. For opening remarks and introduction, I will now turn the call over to Karen Bergman. Vice President, Investor Relations and Corporate Communication. Please go ahead.

[Karen Bergman:]

Thank you, Ellie. And again this is Karen Bergman, good afternoon everyone and welcome FibroGen's financial results and corporate update call for the second quarter of 2017. The call will be led by Tom Neff, our Chief Executive Officer. Tom will kick off the call today with our top line Phase 2results for Pamrevlumab in idiopathic pulmonary fibrosis, and later we’ll discuss our progress and milestones for our product development programs. We are joined today by Dr. Peony Yu, Chief Medical Officer, and she will discuss top line efficacy results from our Phase 2 placebo controlled clinical study assessing the efficacy of Pamrevlumab in the treatment of IPF and the two comparative control sub studies, using Pamrevlumab in combination with approved IPF therapies as well as our anaemia program in China and recent clinical results related to the down regulation of hepcidin. Dr. Elias Kouchakji, Vice President, Clinical Development and Drug Safety and Pharmacovigilance and the Senior Clinical team leader for the Pamrevlumab program will also discuss the safety results from our IPF Phase 2 study. Dr. Seth Porter, Vice President and Project team leader for Fibrosis Therapeutics will provide Pamrevlumab program updates. Mr. Pat Cotroneo, Chief Financial Officer will review financial performance in the second quarter. Also joining us for the Q&A portion of the call is Dr. Eduard Gorina, Executive Director of Clinical Development. On this call we expect to make forward-looking statements regarding our business including our collaboration with AstraZeneca and Astellas, financial guidance, the initiation enrolment, design, conduct and results of clinical trials, research and development activities and certain other business matters. For risks and uncertainties regarding our business and statements made on the call today, as well as factors beyond our control that may cause differences between current expectations and actual results, we refer you to our Form 10-K for the fiscal year ended December 31, 2016 and quarterly reports, including our Form 10-Q for the period ended March 31, 2017 filed with the Securities and Exchange Commission, copies of these filings can be found in the Investors section of our website. We undertake no obligation to update any forward-looking statement whether as a result of new information, future developments, or otherwise. The format for today’s call will include remarks from FibroGen's management team, and then we'll open the lines to take your questions. A webcast of this conference call will be available for replay again on the Investors page on FibroGen's website, at www.fibrogen.com. And now it is my pleasure to turn the call over to our CEO, Tom Neff.

[Tom Neff:]

Thank you, Karen. Good afternoon, thank you for joining us today. This is an exciting time for FibroGen, and we look forward to sharing with you recent advances across our pipeline and in multiple therapeutic indications. First with Pamrevlumab we are pleased to report to you top line results from our randomized placebo controlled double-blind Phase 2 study of Pamrevlumab and IPF and our combination sub studies with the approved drugs. We view these data as an important milestone for the company and for the program and we believe the results of this study enable us to move into Phase 3 with IPF. Study 067 includes a main study and two sub studies first the 48-week placebo controlled study, second two combination 24-week safety sub studies and the double-blind placebo controlled study, a 103 patients to a randomized and 1

[Peony Yu:]

Thank you, Tom. The 067 label study was a Phase 2 randomized double-blind placebo controlled clinical filed to evaluate the safety and efficacy of FG-3019 in 103 patients with idiopathic pulmonary fibrosis with most of the patients in the U.S. IPF is a chronic progressive stable disease characterised by fibrosis in the lung resulting in loss of lung function and exercise capacity. Despite the availability of new drugs for IPF within the last few years, there remains a need for better and safer treatment options. After a screening period of upto six weeks, study subjects receive 30 milligrams per kilogram of Pamrevlumab or placebo intravenously every three weeks for 48 weeks. Lung function assessments were conducted at baseline at weeks 12, 24, 36 and 48. The IPF diagnostics criteria utilized for patient selection were based on the current international guidelines. The key function of assessment of IPF progression is pulmonary function. The primary efficacy assessment is forced vital capacity or FVC. The FVC change from baseline to 48 weeks was analyzed both in FVC measure in ml and in FVC percent predicted adjusted for age, race, sex and height. This ladder parameter FVC percent predicted was designated as the primary endpoint. In the intent to treat population, Pamrevlumab had a statistically significant lower rates of decline than placebo in FVC volume and FVC percent predicted when analyzed using the predefined method of linear slope model also known as random-coefficient linera regression model. The absolute decline in FVC percent predicted from baseline to week 48 was 2.85% in the Pamrevlumab arm as compared to a decline of 7.17% in placebo, an absolute difference of 4.33% thus the relative decline was 60% less than placebo with a p-value of 0.0331. The main decline in FVC volume from baseline to week 48 in Pamrevlumab treated patients of 129 milliliters was statistically less than placebo of 308 ml, with a difference of 178 ml or a relative decline of 58% lower than the placebo arm with a significant p-value of 0.0249. The findings in this placebo controlled study are consistent with an additive to our earlier completed open-label Phase 2 study in IPF, Study-049. Dr. Kouchakji will now present the safety results.

[Elias Kouchakji:]

Thank you, Peony. I would like now to share with you the safety result of our study suppressions [ph] in 48-weeks, main study followed by safety results from the two 48-weeks combination safety study. In this studies Pamrevlumab was well tolerated. In the main study the treatment-emergent adverse events were comparable between Pamrevlumab and placebo. Adverse event in the Pamrevlumab arm of the study were consistent with the known safety profile of Pamrevlumab, while an IPF ofab [ph] is known as a fatal disease. There were lower numbers of that in the treatment-emergent serious adverse event leading to discontinuation reported in the Pamrevlumab arm compared to the placebo arm. For the death [ph], there were a three death in the Pamrevlumab versus six in the placebo. For the treatment-emergent serious adverse event there was a three treatment-emergent serious adverse events in Pamrevlumab versus seven in the placebo arm. In the two sub studies were randomized as double-blind trials with standard of care as a background therapy. Study subject had been on stable dosage of either pirfenidone and nintedanib for atleast three month and were randomized to two to one to receive 30 mg/kg. Pamrevlumab was standard or care or standard of care alone every three weeks for 24 weeks. 36 subjects were on pirfenidone or pirfenidone in combination was Pamrevlumab in 21 nations, 15 in there pirfenidone was Pamrevlumab and six in the combination. Pamrevlumab was well tolerated when dose in combination with either pirfenidone or nintedanib, no safety signal was detected in their respective combination arm compared to either pirfenindone or nintedanib alone. We shall be presenting this data and additional analysis at the upcoming 2017 European Respiratory Society meeting on September 12 in Milan. Thank you for your time today and I will turn the call to Seth Porter. Dr. Porter?

[Seth Porter:]

Thank you, Elias. Just a few program updates to round out this question about Pamrevlumab. With regard to our IPF Phase 2 trial, we have much work to – remains to be done in analyzing our pharmacokinetic data as well as HRCT data. As in the previous Phase 2 study, we analyzed changes in fibrosis by quantitative HRCT at baseline week 24 and week 48. Moving to pancreatic cancer, we expect to complete the assessment of surgical resection of pancreatic tumors by the end of this year or perhaps early next year and so we look forward to those results. In muscular dystrophy we are now enrolling in that trial in a much better pace and we are excited about that. And then one other further development is we are moving forward for our process finalization and scale up for the manufacture of Pamrevlumab so that we are in a position to support Phase 3 programs. With that, I’ll turn it back to Tom.

[Tom Neff:]

Thank you, Seth. Dr. Peony you will now talk about continued progress in our Phase 2 program for roxadustat including new hepcide results [ph] from our recently completed roxadustat Phase 3 anaemia trials in China. Dr. Yu.

[Peony Yu:]

Thank you, Tom. Our large global Roxadustat anaemia progressing well. We are on track to submit the new drug application or NDA to the U.S. FDA in 2018 for Roxadustat our small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase activity for treatment of anaemia associated with chronic kidney disease. As we progress through these studies, we continue to get a green light from the independent data safety monitoring board or the FMB which reviews our U.S. and European Phase 3 program on a quarterly basis. In the most recent review in August, the FMB recommended that our trials continue with our modification to current protocol. In our China anaemia program, on the other side of the globe, we reported positive clinical results from our two Phase 3 pivotal trials earlier this year in CKD anaemia and expect to complete the submission of our NDA to the Chinese FDA in the third quarter of this year. Hepcidin, the key hormone that regulates iron metabolism is generally elevated and contributory to ephyporesponsiveness in patients with inflammation. Consistent with previously reported Phase 2 CKD data from the U.S. and China, a reduction of certain hepcidin levels was absorbed in our two Phase 3 studies in China in Roxadustat in CKD anaemia. In the Phase 3 dialysis study, the mean decrease in strong hepcidin level from baseline to the end of 26-weeks of treatment was 30.2 nanogram [ph] per ml in the Roxadustat arm versus 2.2 nanogram per ml in the epo comparator arm. In the Phase 3 non dialysis study the mean decrease in hepcidin level at the end of eight weeks double-blind treatment was 56.1 nanogram per ml in roxadustat arm versus 15.1 nanogram per ml in the placebo arm p-value was – has seven zeros followed by a five. These results are consistent with the mechanism of action of roxadustat, which not only increases the level of [Indiscernible] epo transiently but also decreases the elevated hepcidin levels in patients with inflammation often seen in CKD and MDS we look forward to keeping you updated on clinical and regulatory advances for roxadustat in 2017. I’d like to turn the call back to Tom. Tom?

[Tom Neff:]

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

[Pat Cotroneo:]

Thanks, Tom. As announced today, total revenue for the quarter ended June 30, 2017 was $29 million. For the same period, operating expenses were $60 million and net loss was $33.2 million or $0.48 per basic and diluted share. Included in operating expenses for the quarter ended June 30, 2017 was an aggregate non-cash portion totaling $11.5 million, of which $9.6 million was a result of stock based compensation expense. As of June 30, FibroGen had $414.7 million and $2 million at the end of 2016. As previously communicated the cash balance includes a financing close on April 11, 2017 which resulted in net proceeds of $115.1 million. For these purposes, total cash refers to cash, including cash, cash equivalents, receivables, investments consisting primarily of investment grade corporate debt and restricted time deposits relating to our building lease. On our balance sheet, the category of long term investments consists entirely of investment grade corporate debt with remaining maturities of fewer than two years. We are currently projecting yearend cash of $370 million. I will now turn the call back over to Tom.

[Tom Neff:]

Thank you, Pat. I would like to reiterate how pleased we are with the results reported to you today in our Phase 2 study of Pamrevlumab and IPF and in the combination sub studies. Based on the work to date, we view these data as Phase 3 enabling and as a significant step forward in both our IPF program and our overall fibrosis program. We look forward to reporting additional analysis from these studies as soon as the data become available. We are heading into the second half of the year with a number of upcoming milestones for both of our lead programs, milestones for Roxadustat include completion of our NDA submission for CKD, anaemia in China anticipated by the end of Q3, 2017 and initiation of our U.S. Phase 3 clinical study in anaemia MDS or myelodysplastic followed by initiation of the Phase 2/3 study in China before the end of the year in the same indication. For Pamrevlumab following todays announcement of positive results in our IPF Phase 2 trial we look forward to reporting further data, reports at the U.S. respiratory society international congress in Milan next month. We will also be reporting pre clinical data comparing Pamrevlumab to approved therapies and a validated mouse model of radiation induced lung fibrosis. After having received orphan drug designation from the FDA for Pamrevlumab in pancreatic cancer we are looking forward to surgical assessment data by early 2018 or possibly sooner. We can now turn to your questions. Operator?

[Operator:]

[Operator Instructions] And our first question comes from Michael Yee of Jefferies. Please go ahead, your line is open.

[Michael Yee:]

Thank you and congrats. This has been a long time coming. You guys have been talking about this drug for a while. Wish you guys, so congrats. A couple of quick questions, number one, what can you say about the next steps, how fast can you go to the FDA? Talk about that. Would you run a mono pivotal study combo, talk a little bit about that. Number two, what did the combination show after six months? What type of FDC declines and then number three what did you see on HRCT? Thanks so much.

[Tom Neff:]

Michael, thank you for your comments. For the next steps we are actively considering two or different trials designs and looking forward to talking to FDA about protocol design and getting some alignment there. In addition we will be speaking with partners in the next couple of months. So this will be a dynamic going forward process, the near term focus is the ERS presentations in Milan. But all these things are planned out in various scenarios and the team will get right back to what now they have definitive data and will help us choose between the various pathways that we have mapped out. With regard to the sub study, there was no endpoint measured for the FVC percent predicted at 24-weeks. This is a safety study, and so the safety characterizations were or over the focus was we did not expect to see benefit or lack of benefit in terms of FVC leaders, FVC percent predicted so to my knowledge it’s actually not been calculated to this point. With respect to HRCT there are several things that we are doing and I will also include the PK studies in this category where we have very interesting data but we have experts also that help us with interpreting the data and when we unblended this study last week, we just haven’t had enough time to go get those experts in place and get everybody have a chance to look at the data and make sure that the interpretations are correct. So HRCT is on our list of things to do in the very near term, but we have not done a computation yet purposefully. I should have drawn the lines of things required outside third party assistance because of the shortage of time.

[Michael Yee:]

Okay, that makes a lot of sense.

[Operator:]

Thank you. Our next question is from Terence Flynn from Goldman Sachs.

[Terence Flynn:]

Hi, thanks for taking the question. Maybe a couple on Pamrevlumab from me as well. Can you tell us what percentage of patients discontinued in each arm for any reason and how were any missing data amputation, particularly the patients that died and then I have one follow up on that?

[Tom Neff:]

So Elias, you want to take that?

[Elias Kouchakji:]

I can start by answering the question results – the amputation process. In the linear slope extension the methods we use there is no amputation is [Indiscernible]. For the patient who completed the study [Indiscernible].

[Tom Neff:]

I think we can get this information but nobody has a write off this….

[Elias Kouchakji:]

So for the completed patients in the Pamrevlumab arm, there is – 40 patients completed their study, and in the placebo arm there is 39 patients who completed this study.

[Tom Neff:]

Thank you. Terence, do you have another question?

[Terence Flynn:]

Yes, I was just – so just to be clear though, what – how if a patient died, how was their last FVC measurement calculated? Like what did you assume for that, again if a patient died, they couldn’t come in obviously for their 4-day week measurement, so how was that datapoint assessed I guess is my question.

[Elias Kouchakji:]

So there is no assumption that is going to be made that is in using the linear projection and that linear projection is computed to access the final results. It is not manual computation or any imputation methodology is used.

[Terence Flynn:]

So is their last observation carried forward essentially or is it an average or the prior, sorry I’m not….

[Elias Kouchakji:]

No it’s not carried forward. I’ll ask Dr. Yu to answer.

[Tom Neff:]

Dr. You, you want to answer?

[Peony Yu:]

Yes, so Terence the statistical method we use is similar to that used in pirfenidone [ph] where there is a linear model that you use all the available time line for projecting in this model. So therefore you don’t – do not need to. So for example, if patient has all available time line [ph] available for every week [ph] except for week 48 then look for the individual patient will be based on all the available time points. This is well described in the New England Journal of 2014 publication on pirfenidone. One of pirfenidone’s alternative analysis as well as in the nintedanib primary publication.

[Terence Flynn:]

Thank you. Okay, and just was the p-value one sided or two sided? Thanks.

[Peony Yu:]

Two sided.

[Terence Flynn:]

Thank you.

[Tom Neff:]

Okay. Next question.

[Operator:]

We do have Michael Yee from Jefferies back on with a question. Please go ahead.

[Tom Neff:]

Michael, sorry I think we had cut off there, please go ahead.

[Michael Yee:]

Hey thanks for the follow up. So my other question was in regarding the safety analysis, can you just talk about anything you saw there other than just deaths? And then how many completers were there in the drug on versus placebo? How many completers, not just discontinuations? So side effect, safety and completers?

[Tom Neff:]

So Mike, I’m going to ask Dr. Kouchakji to answer part of this question. But the completers in the fast population, there are total in 95 completers or 40 and 39. 44 active and 39 for placebo. So you can do the numbers from there, right. So you know and it was 95. Now, Elias is going to answer the other part of this question.

[Elias Kouchakji:]

I think I will answer part of this question by saying first of all the treatment-emergent adverse events were balanced at 96% to 98% respectively from Pamrevlumab to placebo. And serious – as I mentioned is leading to treatment discontinuation that were three to seven. Then there was a no unique characteristic that show that any new risk is identified and it is as has been seen in the published in the previous published in 049 studies, we see similar event that is reported and this study that is what’s reported in their other studies.

[Michael Yee:]

Okay. Thank you.

[Operator:]

Our next question comes from Andy Hsieh from William Blair. Please go ahead, your line is open.

[Andy Hsieh:]

Hi, congratulations on this very exciting clinical progress, Tom, Peony and the team. And thanks for taking my questions. I have a couple, one is really on the potential Phase 3 structure, so I believe the other approved agents were approved based on about 12 to 1300 patients. Would that be a fair number for Phase 3 program? Related to that curious just to hear your thoughts about the potential for an overall survival benefit with that and maybe comment on the potential for that in a label? And also from a partner perspective maybe layout a couple of factors that you are looking for in a potential partnership for Pamrevlumab and that’s it for my questions, thank you.

[Tom Neff:]

So for purposes responding to you, I think the Phase 3 design and the number of patients, so I’ll let Dr. Kouchakji answer there. And also I think you are asking given the trend we have seen with death and progression in both 049 and 067, would we expect to see some sort of survival benefit and all. I’ll ask Dr. Kouchakji to address that as well, and then I’ll take the part on partnering.

[Elias Kouchakji:]

For a design of this study that would be a multiple design as has been discussed as we continued to discuss and the size of this study will be based on the results of this study. So that is – here will be a very active discussion with the regulators and that we could not – this time define exactly what the size of these studies. We would not anticipate that these studies – yes frankly, but we cannot speculate at this time. You asked a question about the mortality assessment. Now we’ve done some assessment on mortality using the [Indiscernible] and what we expect at the same time what the expected mortality for one year in this patient population. The expected mortality in this patient population is 30.2% which is – higher than this is 30 subjects are expected to die in this study. Our total death is nine and if we view this by arm, in Pamrevlumab we expected that to be 6.4, which was around 6 and we have seen only 3 patients in Pamrevlumab arm. Placebo the rate will be 6.5 subject could die according to this expected rate from one known published data and six patient died with the rate of 92.3% of expected [ph] . We can see in this assessment there are different reduction versus placebo of 51%. So one of the things that need not point out that is the mortality in Pamrevlumab arm was only at 40% of the expected rate.

[Tom Neff:]

Yes, so again we are seeing really interesting data that comparison of 40s for Pamrevlumab and 90s for placebo relative you would have expected. The suggest is we need to do bigger studies obviously as the next step. As it relates to partners there are a couple of things that will matter a lot in our analysis. One is, how much time the independent wall or the factors partner negotiations will take for us generally, immediate capital needs as it relates to scaling up or something that’s important to address and to secure appropriate financing. And with respect to partners, we would not want to be waiting around for partners to provide that money where we are loosing time overall, as a critical path matter. And so that kind of idea how much the stipulation of interference with or demanding Phase 3 participation and critical design will be another factor, all these things really relate to time and getting encumbered by things slows down. The other major issue obviously is what the overall business proposition is. We believe, we have the first active factor in fibrosis, anti fibrotic you can call it. It’s a huge category in medicine, depending on the statistics, these are the first or second or third largest killer of humans and there has never been any therapies. And so obviously we want a partnership that is anticipating the breadth of opportunity both in straight [ph] fibrosis and in the cancer arenas where fibrosis is important and in combination with things like the [Indiscernible] medicines. So the vision of what the ideas are and then the proposals by geography. So we are very interested in the U.S. and in China obviously in the other territory is not, so we would look to a partner to be responsive in a manner where we are net better off strategically in those things. And these are the factors that come to mind as the important ones for now though I’m sure there will be more so that we can then do it, but as far as the time issues we will be very sensitive to the – don’t want to loose critical path, time over bargaining back and forth, a very elaborate organisations and – lots of diligence. We want to make sure we stay on our critical path. I hope that helps.

[Andy Hsieh:]

Absolutely. Thank you.

[Operator:]

And our next question comes from Geoff Porges from Leerink Partners. Please go ahead, your line is open.

[Geoff Porges:]

Hi, thanks very much for taking the questions and congratulations again on the results, very encouraging. A couple of questions, first about the data, could you comment on any differences in hospitalizations between the two arms and placebo controlled phase. Secondly, any laboratory differences and then third, could you tell us what the baseline percent and actual FVC were for the patients? And then lastly, and I apologize for all the questions, Tom, could you talk a little bit more about manufacturing, because it looks to me as though you need about 35 kilograms of antibody per 1000 patients, which is going to be a substantial scale up exercise. And when do you think you’ll have a final process, when do you think that you’ll have a facility and what kind of investments do you think you’ll need to make to get to the capacity to supply the market for this ?

[Tom Neff:]

Hey Geoff, thank you. Let me take the manufacturing part first, so that people can find the data you are looking for in the other categories. We have been working on the manufacturing plant very carefully for the past two or three years. There are several manufacturers who are highly skilled than are interested in working with us. The people that we have been working with to date have expressed a high interest in staying involved and we have made the decision to finish process optimization and up scaling of the new method of producing the comparability test there to do that with the people that are involved. Now, we anticipate at some point anywhere from 18 to 24 months from now there would be a second partner brought in because we are mindful of capacity issues and scale issues and we are also mindful that in some of these areas of therapy we are having a meaningful effect on disease, so we have to be sure we can supply the markets that we are entering appropriately. Fortunately it is the case that the people who we were talking to have a scale that they are willing to commit as well as new scale coming online in the next 12 to 24 months that would be available as an additive proposition. And we have gotten to the point with the providers that people are agreeing to and essentially work together because you know instead of trying to argues for exclusivity, people are seeing the need for us to have two producers atleast two producers of the antibody in short order. So all these things are happening I think that the scale of opportunity for something like IPF once you start looking at it, not on the U.S. but as a global batter, that’s a lot of antibody obviously. And with respect to pancreatic cancer at the other end of the spectrum becaseu of how severe the disease is and what the dire circumstances are for patients, there aren’t that many patients out there relative to something like IPF and so it’s much easier to see coverage of pancreatic for instance than IPF. And so we focus on making sure that as it relates to the U.S. and Europe as your first likely approval markets in IPF that we will have enough antibody to be responsive to the known demand. So I think that’s sort of the picture there. Now let’s turn to the other questions. You asked about Hospitalizations and any laboratory differences and then FVC entry as I understood, so Elias do you want to go and address.

[Elias Kouchakji:]

Yes, can address just talking with answering the question. On the hospitalization there was a –on Pamrevlumab arm there was five hospitalization and placebo arm there was seven. For the FVC percent predicted on Pamrevlumab the rate was at 73.4% and the placebo at 71%. The gap score was balanced between the two of…

[Tom Neff:]

Laboratory differences is the other question. Go ahead.

[Elias Kouchakji:]

There were no differences in the laboratory.

[Tom Neff:]

No discernible.

[Elias Kouchakji:]

No discernible differences. And I guess the gap score was similar between the two as….

[Tom Neff:]

So let me qualify there that we are learning this data very very rapidly right now and the top line statistics I agree there is no discernible difference but as we dig into it there maybe some further modification. And if that happens, we’ll get back to you. I’ll let you know.

[Geoff Porges:]

Thank you very much. Appreciate all the answers.

[Operator:]

And our next question comes from Tom Shrader of Stifel. Please go ahead, your line is open.

[Tom Shrader:]

Good afternoon, all I can say is, wow, with 100 patients so good for you. To follow up a little bit on the previous question, looking at placebo arm, your drop was quite a bit less than pirfenidone so are these quite mild patients you treated? Would this be mild IPF or just your sense of the entry patients

[Tom Neff:]

So we are not comparing the pirfenidone in our studies, so I’m not sure I’m quite following what you are….

[Tom Shrader:]

Just the drop in FVC in the placebo arms was quite a lot higher in the pirfenidone on trial -- to have been down with time in IPF.

[Tom Neff:]

I think, I understand this question. I think we can provide some light on it. Dr. Yu, you want to go ahead on this.

[Peony Yu:]

Yes. So I think it depends on which pirfenidone analysis that we are talking about. Just the primary analysis in the pirfenidone Phase 3 was a method that is called rank [ph] and [Indiscernible] and our method, our prespecified method of statistical analysis, the slope analysis is like more like the nintedanib primary analysis. Yet, pirfenidone did do a sensitivity analysis and publish it and put it in the appendix portion of the New England Journal in 2014. And in that analysis, if you would like to first compare this to pirfenidone in that analysis, the decline in the FVC volume in that study was minus – I mean the change was minus 164 ml in the pirfenidone group, the placebo was minus 280 ml in that model. And you’re right, our placebo and pirfenidone placebo were not exactly the same, but I would just like to compare that like with like. And the three month difference between pirfenidone and placebo including that model was 116 milliliter and their treatment, relative treatment benefit was 41.4%.

[Tom Shrader:]

Yes, okay perfect.

[Peony Yu:]

By comparison now – now that study was based on the 52-week. Now the numbers that I reported to you with a treatment difference of 178 ml was based on our 48-week data. Using the same model if we were to project to 52-weeks the three months difference is 180 ml. And the treatment difference is would be also 57% relative to placebo.

[Tom Neff:]

Tom, is that clear enough?

[Tom Shrader:]

Yes, I think I was looking at one of the pirfenidone trials and you're right. By your analysis, the groups are much closer so. And then one other quick question, was reversal of fibrosis, is that a heard endpoint? And do you think that's the basis for breakthrough designation given nothing else does that? Have you talked at all with the FDA about that?

[Tom Neff:]

So we are not in a position to comment on our discussions with FDA about any priority or accelerated type review discussions. It is a matter of history that we used HRCT as primary focus on 049 and it is the case that we’ve been told repeatedly that we are the only people that have ever generated the results in HRCT. In this study, we also did HRCT and we need to do the work with our CROs that have worked with us in the past and who have a lot of gravitas and reputation in this field to access the data we have. You know how important it is and the overall picture for first approval. We don’t have a pre set notion, we are perfectly fine with FVC leaders of FVC percent predicted as endpoints. At the same time we do believe from our prior study that and the extension studies that patients got benefit in terms of what occur on treatment versus what they would have expected otherwise. And we continue to look very closely at both the impact on matrix from the antibody but also let me point out that we’ve been doing PK studies in parallel, and so if you recall in our pancreatic cancer program the notion of having a continuous minimum antibody at150 nanograms per millilitre was something that was shown to have mortality benefit. We have now found independently study 067 that there is a Semin [ph] in level which is just a little bit higher than that. I won’t go into the – we’re going to publish and pattern. But there is a semin [ph] in if we attain it where all patients that have been treated had benefit. And so we are very, very excited about applying this in the next trial design to Semin in concept in the IPF program. You might ask in 067 why we didn't do this. And the answer is actually pretty simple. We started 067 before the approval of the two drugs in America and we tried very hard to get enrolled ahead of the rollouts. We were not able to do it. So it started in 2013 and the work that was done in pancreatic cancer on the Semin really was 2015 2016 and got published right at the beginning at 2017. And so, this is something that we are seeing we are seeing very compelling data with an idea that we know has relevance in other disease area, and we would seek to modify dose so for example one way we could get to the levels that have been instead of 30 mg per kg very three weeks. If we did 30 mg per kg every very two weeks we would get up to the kinds of PK levels where you've been looking for the Semin level I described and expect to see its. So that kind of adjustment is in the offing and we are very excited about it. So that’s [Indiscernible].

[Analyst:]

Yes. Absolutely. Congratulations again.

[Operator:]

And our next question comes from Joel Beatty from Citigroup. Please go ahead.

[Joel Beatty:]

Hi, and congratulations. Couple of questions on Pamrevlumab. The first is on the combination therapies sub study. I know that is available yet, but would you expect a similar magnitude of benefit in sub study as was seen and in the main study even though the powering may not be there? And then the second question is on the ERS conference coming up in September, is it possible that the additional data there beyond what was presented today such as the HRCT data and sub study results? Thanks.

[Tom Neff:]

Dr. Beatty, thank you. Let me try to address this question. We do not have an expectation in 24 weeks of FVC results with the antibody, we simply have not studied as a performance endpoint to date and the sub studies are only 24 weeks in duration. So the focus of the substudies was is there any unexpected safety event or any synergistic effect of the two drugs that occurs in a manner which might be dangerous for patients, it is not been seen previously. And so we really haven't tried to turn into a backdoor, look in the more data to this point. I'm not saying we might not do it someday but it's not in protocol. And so that's the situation there. As it relates to ERS I do expect that there will be more data presented. I don’t want to front run anything but I think we’ve heard about the radiation-induced liver and lung fibrosis model's, this rodent model that we used in the past improved reversal. We now have a comparison of each of the two approved drugs in Pamrevlumab , one by one each one properly power and then studies or one of those drugs is added to Pamrevlumab and then another study were the others added. And then finally, a study where all three are added, and we think the data are very interesting in that study and we’re looking at because it shows where the statistical significance emanates from and that's all I can really say right now about that. We may have something on PK to talk about – I’m not sure yet about that. But we’re certainly trying to get there. For HRCT I also am not quite sure on the timeline to get everything done because it depends on third-party advisors being available and this is summertime particular the next three weeks is the only part of the summer that most people get off at all in this part of the U.S. So I think we have to be mindful of that. But we’re going to do what we can – as fast as we can to get data to everybody.

[Joel Beatty:]

Got it. Thank you.

[Tom Neff:]

Yes. Thank you.

[Operator:]

And we have Terence Flynn from Goldman Sachs. Please go ahead. Your line is open.

[Terence Flynn:]

Hi. Thanks. I just want to follow-up again on my question. Just wondering if you excluded the deaths from each of the two arms, if you tell us what the Delta would be? Does the Delta narrow at all or does it stay pretty similar to what you saw. I just want to kind of sensitivity around the death with respect to the FEC Delta? Thank you.

[Tom Neff:]

Terrace, thank you for coming back with another question, I'm looking at my MDs here to see they’ve actually got this kind of data right now?

[Peony Yu:]

So, we have not yet analyze this data as to say in this part of our continuous effort. And now we are looking as the Tom said that that additional analysis would be ongoing.

[Tom Neff:]

So that’s where we are Terrence now and for now and we’ll get out as soon as we can.

[Karen Bergman:]

Operator, I think we’re ready to conclude the call. Thank you everyone.

[Operator:]

Any further final remarks.

[Tom Neff:]

To everyone on call, thank you for joining our call today. We are very pleased to be able to share one IPF results with you today. We're excited about them. We look forward to reporting additional progress across our pipeline in coming quarters. I'd like to wish everyone a good afternoon and evening and good August summer, restful vacation time, hopefully. Thank you all for attending.

[Operator:]

Thank you, ladies and gentleman. This concludes today's call. Thank you participating. You may now disconnect.