FibroGen, Inc.
Q4 2017 Earnings Call Transcript

Published: 28 Feb 2018

[Operator:]

Welcome to the FibroGen Incorporated Fourth Quarter and Year End 2017 Financial Results Conference Call. My name is Agen and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. 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 of Investor Relations and Corporate Communications. Please go ahead.

[Karen Bergman:]

Thank you, Agen. Good afternoon everyone. Thank you for joining our call today. We are reporting financial results and corporate update for the fourth quarter and year end 2017. Joining today's call will be Tom Neff, our Chief Executive Officer who will begin by reviewing our late stage product development programs. Dr. Seth Porter, Vice President of Fibrosis Therapeutics, who will provide update on our Pamrevlumab program. Dr. Peony Yu, Chief Medical Officer, who will discuss updates on our anemia program. And Mr. Pat Cotroneo, Chief Financial Officer and he will review financial performance for the quarter 2017. Tom will then wrap with discussion of our goals for 2018 to 2019. Following our prepared remarks, we will open the call for Q&A where we will also be joined by Dr. Elias Kouchakji, Vice President, Clinical Development, Drug Safety and Pharmacovigilance. And Ms. Chris Chung, Vice President of our China Operations. On this call, we do expect to make forward-looking statements regarding our business, including our collaborations with AstraZeneca and Astellas, financial guidance, the initiation enrolment, design, conduct and results of our clinical trials, our regulatory strategies, and potential regulatory results, our 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, 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. Once again, the format for today's call will include remarks from our management team, and then we'll open the lines up to take your questions. A webcast of this conference call will be available for two weeks on the Investors page of our website, www.fibrogen.com. And with that it's my pleasure to turn the call over to our CEO, Tom Neff.

[Tom Neff:]

Thank you, Karen. 2017 was a fantastic year for both of our lead programs, Pamrevlumab and Fibrosis and Roxadustat and anemia. We achieved multiple clinical and regulatory milestones. Starting with our Pamrevlumab program, from our Phase 2 double-blind placebo-controlled study PRAISE in patients with idiopathic pulmonary fibrosis. Significant treatment effective Pamrevlumab has been shown in multiple parameters clinically important and IPO. This includes lung function, proportion of patient's suffering, disease progression, CT assessment of one fibrosis and health related quality of life measures. In August 2017, we first reported meeting primary efficacy endpoint of change in forced bio capacity predicted was statistically significant results. As well as bio volume metric changes in FPC measured in milliliters. We also reported the lowering of the rate of disease progression to 10% in Pamrevlumab arm versus 31.4 % of the placebo arm over 48 weeks of treatment with a p-value of approximately 0.01. Disease progression was defined as FPC percent predicted minus 10 or greater or death. These efficacy results and safety data were reported at the European Respiratory Society International Congress in September. High-resolution computed tomography or HRCT was used to assess the progression of fibrosis from baseline week 24 and 48. Quantitative lung fibrosis assessment in collaboration with our med QIA a group shows statistically significant attenuation of fibrosis at 24 and 48 weeks. While the methods have advanced for analysis of HRCT measures over the past half decade, the results from study 068 are consistent with our first open-label ICF study 049. Pamrevlumab is the first IPF drug candidate reported to have statistically significant effect on fibrosis. To evaluate the impact of Pamrevlumab on IPF patients, how they feel and their activities we use two health-related quality of life measures for respiratory disease. There is a statistically significant difference between Pamrevlumab and placebo treated patients and the UCSD shortness of breath questionnaire suggesting reduction of [Disnea] by Pamrevlumab. We also saw compelling results from the St. George's respiratory questionnaire that is validated for COPD and has been broadly applied in IPF. We plan to present the HRCT data, the UCSD shortness of breath questionnaire and the St. George's respiratory questionnaire results at upcoming respiratory conferences likely to be either ATS or ERS later this year. Finally, it is important Pamrevlumab safety profile and study 067, death rate was half of placebo with the rate of treatment of merger MACE leading to discontinuation only 43% of placebo arm. It was well tolerated without safety signals. In conclusion, the totality of data from the Phase 2 IPS studies, FBC disease progression, quantitative HRCT, health-related quality of life and an acceptable safety profile suggesting that Pamrevlumab has distinctive potential to be a beneficial treatment for patients with IPS. We are making a concerted effort in our Phase 3 clinical development plan or IPF that we would like to share with you by mid-year. In pancreatic cancer, we are developing Pamrevlumab for patients in LAPC who are not eligible for local --for resection. LAPC refers to locally advanced pancreatic cancer. There is no standard treatment for this patient population who face a short life expectancy and Pamrevlumab may represent an entirely new approach for this serious and fatal condition. In our Phase 2 trial, we observed that treatment with combination of chemotherapy plus Pamrevlumab changed eligibility for surgical resection of a majority of the treated patients from non resectable to respectable. A clinically important result that had not been previously reported with other drug candidates. While there is no standard of care for locally advanced pancreatic cancer, the control arm in this study received chemotherapy, while the treatment arm received chemotherapy Plus Pamrevlumab. The combination with Pamrevlumab yielded a rate of resectability and resection several fold greater than chemotherapy alone. Successful resection is expected to provide a better outlook for survival as compared to non-resected patients. Moving to our anemia program, 2017 was an equally exciting year for Roxadustat. Back in January 2017 we reported positive safety and efficacy results from two China Phase 3 pivotal studies of Roxadustat for the treatment of anemia associated with chronic kidney disease. These results supported our Roxadustat NDA for treatment of CKD which was accepted for review by the China Food and Drug Administration or CFDA in October 2017. That filing triggered payment of $15 million milestone to FibroGen bio partner AstraZeneca. In China, Roxadustat has received priority review designation from the CFDA. Certain activities in the NDA review process such as clinical trial site inspection, manufacturing site inspections have been initiated or are partially completed on schedule with projected approval timing. We expect to remain actively engaged in managing review and inspection activities in the next few months. We are on track in the establishment of our commercial API manufacturing facility in Cangzhou, Hebei; construction is substantially completed as is equipment installation. We will be focusing on plant commissioning and process transfer and qualification in the upcoming months. The FibroGen AstraZeneca China commercialization team is in launch preparation mode. A top launch priority is addressing critical market access constraints in China such as gaining hospital listings and gaining entry into various reimbursement lists. Both companies are staffing up to ensure we are launch ready when the NDA is approved and the first batch of commercial product is released. For our US. Program, we and our partner AstraZeneca have agreed that continued projections of adjudicated MACE severance in various scenarios are no longer needed and instead now we have set study completion timelines as follows. To complete enrollment in the second quarter of 2018; to report top-line results in a fourth quarter of 2018 and to file the NDA for Roxadustat CKD anemia during the first half of 2019. We are also working with Astellas to discuss corresponding timetables for Europe and Japan and expect to have a plan soon. In other therapeutic indications, we recently achieved first in patient for study 0A2 of first patient and study for set patient only two - this is the MDS study in the US. Evaluating Roxadustat for treatment in anemia in patients who are on transfusions so to reduce or eliminate transfusion dependence. I would also like to provide an update on our plan for expanding Roxadustat indications. Jointly with AstraZeneca, we have committed to progressing further evaluation of chemotherapy induced anemia in the US and in China. CIA is a very large market opportunity where the use of ESA therapy has dropped for more than five billion annually to virtually nil due to the well-documented safety problems associated with ESA products. After intensive study over the past few years, we believe Roxadustat profile differs in numerous respects as the hip mechanism addresses all aspects of erythrogenesis without exposure to excessive levels of IPO. As such we believe that Roxadustat can provide a much needed therapy that can overcome the inflammation, a common hurdle for IPO and avoid the documented safety problems of ESA. Moving on to corporate matters, FibroGen is focused entirely on executing the necessary steps that will realize the potential in our product pipeline and build value for our shareholders. In April, we raised $115 million supporting the expansion of Roxadustat into new indications in China and in August we raised $356 million supporting the advancement of Pamrevlumab into Phase 3 and pivotal studies in IPF and pancreatic cancer. We continue to be most grateful and appreciative for the support we receive from our investors and our analysts as we advance our primary objective of delivering first in-class therapies to patients with limited or no treatment options. We concluded with 2017 with $762.2 million in cash and cash equivalents. And with that I'd like to ask Seth Porter to discuss the status of our Pamrevlumab product program platform in more detail. Seth, please go ahead.

[Seth Porter:]

Thank you, Tom. As Tom mentioned in August 2017, we reported positive top-line results from our randomized double-blind placebo-controlled Phase 2 clinical trial study 067, designed to evaluate the safety and efficacy of Pamrevlumab in patients with mild to moderate IPF. We also presented top line results from two sub studies that were added to evaluate the safety of combining Pamrevlumab with approved IPF therapies. In the double-blind placebo-controlled 48 week portion of the study, 103 patients were randomized one to one receive either Pamrevlumab or placebo every three weeks. Lung function was assessed at baseline and at weeks 12, 24, 36 and 48. Quantitative HRCT assessments were performed at baseline week 24 and week 48. Pamrevlumab met the primary efficacy endpoint of change in FVC, the same primary endpoint used in pivotal trials for approved IPF therapies. The average decline in FVC percent predicted from baseline to week 48 was 2.85 in the Pamrevlumab arm as compared to an average decline of 7.17 in a placebo arm. A statistically significant difference of 4.33 with a p-value of 0.0331. Similar results were obtained for FVC values Pamrevlumab treated patients had an average decrease in FVC of 129 milliliters at week 48, compared to an average decrease of 308 mils in patients receiving placebo. A statistically significant difference of 178 milliliters, a relative difference of 57.9 % with a p-value of 0.0249. In addition, the proportion of patients with disease progression defined as FVC percent predicted decline greater than or equal to 10% or desk was lower in a Pamrevlumab group compared to placebo at each assessment. The difference between treatments was statistically significant at weeks 36 and 48. Specifically at week 48 in the Pamrevlumab treated arm only 10% of subjects experience disease progression or death compared to 31.4% in the placebo arm with a p-value of 0.0103. The percent of Pamrevlumab patients who experience disease progression and also this continued therapy was less than 15% of that in a placebo arm. With regard to high-resolution CT assessments, we measure quantitative lung fibrosis using HRCT at baseline week 24 and week 48, using computer algorithms developed at UCLA to specifically assess the forms of lung fibrosis that are characteristic of IPS. And to measure changes in them over time. We found a statistically significant continuation of fibrosis progression from baseline in the Pamrevlumab treated arm versus the placebo arm at both week 24 and week 48. Furthermore, a correlation between changes in FTC percent predicted and quantitative lung fibrosis was confirmed at both weeks 24 and 48. The correlation between changes in FVC and quantitative lung fibrosis is consistent with the results obtained in our open label Phase 2 study, study 049. And strengthens our belief that Pamrevlumab is truly anti-fibrotic and can lead to benefits in both lung structure and function. We are not aware of any therapy that is shown a statistically significant effect on lung fibrosis is detected by similar quantitative measures of lung fibrosis. Pamrevlumab treated patients also achieved a clinically meaningful improvement in health-related quality of life using the St. George's respiratory questionnaire or SGRQ comparing active to placebo during the 40 week treatment period. The SGRQ is a respiratory quality of life instrument that is validated in chronic obstructive pulmonary disease. Additionally, a subset of 43 clinical trial subjects were assessed using the UCSD shortness of breath questionnaire that yielded a statistically significant difference between active and placebo arms and indicated Pamrevlumab may attenuate the progressive worsening of Disnea in IPS patients in comparison to placebo. Consistent with previous studies, Pamrevlumab was well tolerated. TAES were mild or moderate in severity and consider typical of the patient's underlying medical conditions. In fusion related TAES were generally mild compared with placebo fewer Pamrevlumab patients were hospitalized following an IPF related or respiratory TAES or died for any reason. The reduction in mortality over placebo was an important and encouraging clinical finding. The comparison is a pulmonary function outcome, disease progression; safety and mortality discussed above were largely presented in September at the ERS meeting. We plan to present the SGRQ, UCSD shortness of breath questionnaire and HRCT results in upcoming medical conferences. Our IPF team is focused on reviewing data with thought leaders and investigators to develop our Phase 3 trial program. Switching to pancreatic cancer. In January 2017, we reported interim results from a randomized active control neoadjuvant Phase 2 trial combining Pamrevlumab with nab-paclitaxel plus gemcitabine in 37 patients with locally advanced pancreatic cancer at the ASCO GI symposium. We completed an enrollment in this trial in first half of 2017 and completed the six month treatment period and surgical assessment at the end of 2017. A greater proportion of subjects treated on the combination arm were converted from non-resectable to resectable status consistent with our data reported at the ASCO GI meeting. Based on these promising results, the pancreatic cancer team is working to prepare an FDA briefing and finalize a pivotal trial protocol. If Pamrevlumab can be proven to enhance tumor resection in patients with otherwise non-resectable tumors, it would be expected to double their survival time based on post-hoc analysis of resection benefit. Switching now to Duchenne muscular dystrophy, with regard to our ongoing phase trial evaluating Pamrevlumab in the treatment of Duchenne muscular dystrophy. The trial is focused on non-ambulatory DMD patients. And we are making good progress toward our enrollment goal of 22 patients. Based on what we believe to be the anti-fibrotic mechanism of action in DMD, the trial is not specific for any particular dystrophy mutation which may allow Pamrevlumab to benefit a broad DMD patient population. Thank you for your time today. I'll turn the call back over to Tom.

[Tom Neff:]

Thank you, Seth. Dr. Peony Yu Fiona, our chief medical officer will now talk about our global Phase 3 program for Roxadustat, in addition to providing comments on activity in China and Japan and other opportunities for this program. Peony?

[Peony Yu:]

Thank you, Tom. As many of you know we and our partners as with AstraZeneca and Astellas are conducting a global Phase 3 program designed to support regulatory approvals of Roxadustat for treatment of CKD anemia in dialysis and non-dialysis dependent patients in the United States, European Union, Japan and China. Our US and EU Phase 3 program has an aggregate target enrollment of more than 8,000 patients. And is the largest Phase 3 clinical program conducted to date for development of an anemia drug. As previously described, the Phase 3 program is powered to demonstrate cardiovascular safety using MACE composite endpoint as primary safety endpoint. MACE is being evaluated in two separate study pool dialysis dependency CKD patient and non-dialysis dependent CKD patients. In the non dialysis Phase 3 studies, Roxadustat has been compared to placebo. The regulatory requirement is to demonstrate superiority on efficacy and non-inferiority on safety. For dialysis dependent patients, Roxadustat is compared to a HIF alpha and the regulatory requirement is to show non- inferiority in efficacy and in safety. Safety data from Roxadustat Phase 2 and Phase 3 studies have undergone a number of periodic reviews by an independent data safety monitoring board or DSMB on a regular basis. The DSMB has consistently recommended most recently in December of last year study continuation under the current protocol with no changes. In support of the US NDA submission, we and AstraZeneca are completing Phase 3 program enrollment in the second quarter of 2018. Data readout from our Phase 3 studies is planned for the fourth quarter of 2018, and we are targeting submission of US NDA during the first half of 2019. Turning to China. CFDA accepted our China NDA filing of Roxadustat for treatment of CKD anemia in Q4, 2017. This NDA represents the first filing of any HIF PH worldwide. China could be the first approval country for a first in-class drug, and we would be privileged to be part of that. In Japan, a partner Astellas has announced the completion of three of his six Phase 3trials, top line results from a study in peritoneal dialysis patients were reported last year and Astellas has stated that data readout from the other two completed studies in dialysis patients are planned for first quarter of 2018. 2018 is an exciting year for Roxadustat as we look forward to the results from a number of Phase 3 studies we're preparing and supporting NDA of this first in class drug around the world. We will update you as appropriate during the coming year. A brief updates on other Roxadustat programs. We are also pursuing other opportunities in our anemia therapy and have launched development of Roxadustat in myelodysplastic syndrome or MDS. MDS is a serious disorder that impairs the ability of the bone marrow to produce healthy red blood cells and is in most cases associated with anemia. There is no approved treatment for anemia in MDS patients in the US or in China. We start a patient dosing in our Phase 3 global study in transfusion dependent MDS patients and will start enrolling non-transfusion dependent MDS patients into a separate Phase 2, 3 studies in China in first half of 2018. We are actively evaluating opportunities to expand Roxadustat indications beyond an anemia of CKD and MDS among the various types of anemia, we and AstraZeneca identified chemotherapy induced anemia or CIA in cancer patients to be most compelling in light of the unmet medical need. The large market potential and the extensive preclinical efficacy and de-risking safety results in support of this indication. At present, we are making plans for the optimal development path in both the US and China. I'd like to now turn the call back to Tom.

[Tom Neff:]

Thank You Peony. Pat Cotroneo, our Chief Financial Officer will walk us through financial highlights for fourth quarter and year end 2017. Pat?

[Pat Cotroneo:]

Thank you, Tom. As announced today, total revenue for the quarter ended December 31, 2017 was $42.5 million. For the same period, operating expenses were $66.3 million; a net loss was $22.1 million or $0.27 per basic and diluted share. Included in operating expenses for the quarter ended December 31, 2017 was an aggregate non-cash portion totaling $11.8 million of which $9.9 million was a result of stock-based compensation expense. Total revenue for the year ended December 31, 2017 was a $125.7 million. For the same period, operating expenses were $248.3 million and net loss was $126.2 million or $1.73 per basic and diluted share. Included in operating expenses for the year ended December 31, 2017 was an aggregate non-cash portion totaling point $45.3 million of which $37.5 million was a result of stock-based compensation expense. As of December 31, 2017, we had $762.2 million in cash as compared to $342.2 million at the end of 2016, reflecting the net returns of our two recent financing. 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. With the submission of our NDA filing for Roxadustat in China, we received a $15 million milestone from our partner AstraZeneca during the fourth quarter of 2017, which was fully recognized as license and milestone revenue in the same quarter. We are currently projecting 2018 year-end cash balance in the range of $600 million to $620 million. Thank you everyone. And I would like to turn the call back over to Tom.

[Tom Neff:]

Thank you, Pat. 2018 looks to be an exciting year for both Pamrevlumab and Roxadustat relating to the most advanced indications in Pamrevlumab, an IPF we expect to report data supporting benefits of Pamrevlumab disease progression fibrosis and patient reported outcomes at upcoming medical conferences either ATS or ERS. Our near-term focus is on designing an optimal Phase 3 program for supporting product registration. In pancreatic cancer, we plan to report results from our Phase two trial Pamrevlumab and locally advanced pancreatic cancer at an upcoming medical conference. We hope to very shortly have pivotal trial design agreed with FDA. For Roxadustat with our partner AstraZeneca, we plan to report results from our Phase 3 Roxadustat studies in CKD anemia in the fourth quarter of 2018. We and AstraZeneca expect to file a US. NDA for Roxadustat and anemia of CKD in the first half of 2019. We are working with Astellas to finalize plans for filing in the EU and Japan. In Japan, we expect data readouts from long-term human dialysis ESA conversion study and hemodialysis correction studies during the first quarter of 2018. In China, we anticipate we may receive a market approval decision for Roxadustat NDA for CKD anemia by the end of 2018. We expect further work with both our partners on a strategic plan for new indications particularly in CIA. With that I would like to turn the call back over to Karen for question and answer. Karen?

[Karen Bergman:]

Thanks Tom. Operator or Adrian if you kindly open up the line for questions.

[Operator:]

[Operator Instructions] Our first question comes from Michael Yee from Jefferies. Please go ahead.

[Michael Yee:]

Hey, guys, thanks, good afternoon. Appreciate the updates, two questions for you. One for Tom, appreciate the details around the timing for data this year. I look forward to that maybe you can comment around what changed in terms of the analysis around the adjudicated events. Was it just hitting the number of events or was there great clarity on how that was progressing and perhaps the blinded event rate? In other words just comment on what you saw there and why you feel perhaps good about that? And then my other question is on Pamrevlumab presumably the pancreatic data should be finished or near finished maybe just comment about when we can see that data and how that plays into when you will just announce your regulatory update? Thanks so much.

[Tom Neff:]

So for Roxadustat and AstraZeneca, Michael, look I think really what happened was we've had an ongoing effort to count adjudicated unique MACE events for a couple years with efforts to project in various scenarios when we would pass the statistically required numbers. And as you look at the totality of those efforts of counting and projecting, we got to the point that we felt like we were adequately covered in all the scenarios we could think of as being reasonable. And as a result, we said we now need to really focus on execution and that they're in there really was a decision to move to a timetable based approach to get to the NDA. Elias, I think maybe you would like to take pancreatic cancer question please.

[Elias Kouchakji:]

Hi, Mike. And for the question on the pancreatic cancers, as you heard from Seth, the study is completed enrollment in the resection although the patient is still on this study. So the analysis is still ongoing and the patient is being followed. We hope to have this data is available by mid-year. Thank you.

[Michael Yee:]

Okay. just if I going to want one follow-up for Tom on what you said about roxa, can you extract any information or any information about the blinded event rates that make you feel good about the study or make you feel good that the event rate should hit non-inferiority?

[Tom Neff:]

What we can do about this is look at the pooled event rates in the non-dialysis and the dialysis area, and what I'll do is let Peony comment on exactly what we've seen to date with these pooled analysis so that you get the details accurate from this horse's mouth. Go ahead with that Peony.

[Peony Yu:]

Mike, as you know, that since the studies are the program still ongoing also we are seeing that we are near completion the assessments that we can make by following the MACE event rate along is the combined a rate after both treatment arms. And we are namely in non-dialysis although that the patients in this study have a more advanced kidney disease than previous than reported in previous trial in non-dialysis patients. The event rate from a based on per patient exposure year, we have observed that to be lower than the previous reported studies. Similarly, in the dialysis pool, the combined rate also appears to be lower than previously reported studies in EPO. And at this time, and this is about all we can comment on the rate and we have already made adjustments along the way and using sample size so we are very comfortable with where we are in this program as well as the timeline for completing this program.

[Operator:]

And our next question comes from Terence Flynn with Goldman Sachs. Please go ahead.

[Holly Barra:]

Hi. This is actually Holly on for Terrance. Thanks so much for taking the question. When you release the data for roxa CKD, will you plan to report top-line data from the non-dialysis and dialysis patients together or sequentially Thanks.

[Tom Neff:]

So I think the thinking in that area is that we will have top-line data to report in the fourth quarter. What we won't be able to report in the fourth quarter is the pooled MACE analysis. And so I think we are looking at this as getting the studies done, the five between FibroGen which has three and AstraZeneca which has two getting these studies done as promptly as is possible with no intent to sequence or a couple or anything just get them done. The Astellas studies I have to indicate here that we haven't had a chance yet to meet with the Astellas upper management on the scheduling. So we'll know in a week or two about the plan there, but potentially two more studies with the Astellas. And the core activity for the remainder of the NDA is really very, very close analysis the pool MACE and in each non-dialysis versus placebo and in dialysis versus support in health. So that's the current thinking.

[Operator:]

And our next question comes from Andy Hsieh from William Blair.

[Andy Hsieh:]

Hi. Thanks for taking my question and congratulations on a very successful 2017. Just want to follow up on Michael's question, is it fair to characterize the change for the MACE study to be from event driven study to a landmark study? Is that a fair characterization?

[Tom Neff:]

Peony do you want to take that on?

[Peony Yu:]

Sure. Andy, the nature of the study has not changed. What has changed is that we have much more data based on what we have been tracking during the course of the Phase 3. And we are at the point that we are confident that we will have sufficient data to meet our safety data requirement for the program. Does that help?

[Andy Hsieh:]

So, right so I guess the question has to do with the analysis plan so it my interpretation and please correct me if I'm wrong, it sounds to me that what Tom described the change can be characterized as basically going from event driven right, you need to hit certain number of events to a landmark which means once you hit a certain time, you stop the trial, and then do analysis. Is that a fair characterization about the change?

[Tom Neff:]

Andy, let me try this. We have looked at scenarios for cumulative MACE count a variety of scenarios. I'm sure you can think of a few and we have come to the conclusion that we are likely to exceed necessary MACE numbers in non-dialysis and the scenarios we know about there and in dialysis and the scenarios we think about there. In the eventualities that we think are likely to happen and as a result there's a judgment made that we are adequately covered now across the range of possibilities and so instead of having things focused on the forecasting exercise and the counting which of course involves an Education Committee and there's a little bit of a lag effect, everyone's agreed we don't need to do that anymore. We just need to focus on getting done and. So it's really an agreement with our partner AstraZeneca that we are now executing against a timetable given that we have met the MACE requirements across the categories that we think are likely to happen. Is that clear enough?

[Operator:]

And the next question comes from Geoffrey Porges with Leerink. Please go ahead.

[Geoffrey Porges:]

Hi, thanks very much for taking the question. Just wondering if you could give us a little sense of a way while with Pamrevlumab now in terms of the dose you've been studying to 35 milligrams per kilogram wondering if you're taking that dose higher? And secondly, if we received any feedback on respectability as a viable pivotal trial endpoint in pancreatic cancer? Thanks.

[Tom Neff:]

Elias, go ahead.

[Elias Kouchakji:]

Geoff, first of all respectability, we have not yet spoken with the agency, but this is as planned, so we are in the process of preparing for this discussion. For the dose, as you mentioned, we -- some of our studies in pancreatic cancer is 35 mg per kg every two weeks while in IPF we studied this at 30 mg per kg every three weeks. We are doing some work and simulation, you have seen some of this is presented and we think that there is a still an opportunity to modify this dose. So the final dose have not yet been defined for the IPF and now we will take this again as if one our follow-up discussion with the agency was a very convincing argument how we will need to update the dose to support a wider therapeutic margin as I'd like to emphasize that therapeutic margin we are in now is very good, that if we can go above and beyond this as we should to make our best effort for the patient benefit.

[Operator:]

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

[Joel Beatty:]

Hi. And thanks for taking the questions. First one is on Roxadustat. Could you discuss -- is a trial powered to show superiority do you see that as a potential for either the non-dialysis or dialysis patients?

[Tom Neff:]

Peony you can answer there.

[Peony Yu:]

Okay. So as you know as mentioned for non-dialysis for comparison with placebo efficacy target is for superiority and for non -- for safety comparison the regulatory requirement is the non-inferiority as you know that placebo is the gold standard for safety and so we are power to show that when a drug is non -inferior to placebo is absolutely safe. Now if we can further derive benefits of such safety benefits from anemia treatment then we see that as an icing on the cake. As for the dialysis program, the regulatory requirement is the non-inferiority in the efficacy and non-inferiority is in safety endpoint. And we would also perceive an opportunity to be superior in safety to be a plus. In the China study also we originally power for non-inferiority, we ended up demonstrating superiority and efficacy that is study 806. So until we see the data we will hopefully have a more direct answer at that time.

[Joel Beatty:]

Okay, thanks for that. And one other question regarding the cash balance guidance. Does that include any Phase 3 cost for Pamrevlumab?

[Tom Neff:]

Pat you want to take that one?

[Pat Cotroneo:]

No. It doesn't.

[Operator:]

And the next question comes from Difei Yang from Mizuho Securities.

[Alex Pham:]

Yes, hi, guys, this is actually Alex on for Difei. Thank you for taking the question. You mentioned earlier you expect the decision in China for CKD anemia by the end of 2018. Are there any steps leading into final approval like for example the ADCOM meeting in the US anything similar there?

[Tom Neff:]

Chris do you want to take that on?

[Chris Chung:]

Sure, absolutely, hi Alex. So China there are [Technical Difficulty] exactly very similar to CFDA. However, it's entirely up to the judgment of CFDA as to where they're needed. At this point in time, we've not received any indication as to whether the CFDA plans to cost actually.

[Alex Pham:]

Okay, got it, that's useful, thank you. And then just one on IPF could you share at this point any in color on the Phase 3 trial and what that might look like? Will it have an active control arm?

[Elias Kouchakji:]

So this is Elias. At this time we are still and have not made the final decisions. They are still -- this is will be up after the discussion with the agency. We already developed a multitude of scenarios and all this will be presented hopefully in the near future.

[Operator:]

And our next question comes from Alex Schwartz from Stifel. Please go ahead.

[Alex Schwartz:]

Hi, Tom and team. Congrats on all the progress this year and thanks for taking my questions. This question may be for Seth. So with the IPF data you release in your January corporate presentations, you go into HRCT data that shows Pamrevlumab fibrosis first placebo and you talk about a subgroup of 90 patients that had more significant attenuation in their fibrosis. So can you go more into these patients? Are there any identifiable characteristics by baseline or biomarkers that might be predictive of who might respond and then secondly can you maybe help me with the context of the data a little bit more. Was it a few patients to add a more significant attenuation or reversal in their fibrosis or is it that most patients had some attenuation in their fibrosis or both?

[Tom Neff:]

So Alex this is Tom Neff. I think you have a misconception here I have to correct. Okay, we referred to today the HRCT data that we worked on with MEDQI involves all patients not a subgroup and it is done in the same rigorous manner that the FVC data was done. So what you saw in January was a comparison at the time to something reported by a company that has an approved product in the area. And we were not yet quite finished with the MEDQI analysis that will be presented either at ATS or ERS later in the year. So just to frame it properly that's the situation. Do you want to reframe the question for Seth?

[Alex Schwartz:]

So maybe I just help me a little bit more, so the 103 patients in the 48 weeks, there's 90 patient subgroup analysis. Can you just kind of or maybe help me understand it better kind of what's the difference between those two populations?

[Seth Porter:]

So as I mentioned that 90 patient analysis was done earlier and we hadn't completed our analysis. We've now completed our analysis and we've looked at the entire intent to treat population. And so the data that I reported that we reported today showing statistical significance of week 24 and week 28. That's for the entire population. We have a HRCT data. So if I would really focus on that, the data that we were that were reported during JPMorgan in terms of 90 patients that was sort of an interim assessment and for that a number of patients were taken out of the analysis pool because they were largely from one country in which we had sort of unexplainable results. We've now moved beyond that and so I don't think we need to focus on that subset analysis.

[Tom Neff:]

Part of the rigor and looking at the data was looking for any unusual subgroups and there was one particular country in which they treated did worse and the placebo did better kind of thing. And you just sort of stare at it and say is that really real and that investigation is ongoing actually but the results were reporting for HRCT that we discussed on this call is on the 403 and it is statistically significant both the 24 and 48 weeks. And this concludes the Q&A session. We will now turn the call back over to Tom for final remarks.

[Tom Neff:]

Thank you all for joining the call today. I would like to express my thanks to our FibroGen teams in the US and in China for an incredible year. And my gratitude to our partners and our investors for their support. We look forward to updating you on our progress in the coming quarters and year. I'd like to wish everyone a good afternoon and good evening .Thank you very much for being here.

[Operator:]

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating and you may now disconnect