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Edited Transcript of FGEN earnings conference call or presentation 8-Aug-19 9:00pm GMT

Q2 2019 FibroGen Inc Earnings Call

SAN FRANCISCO Aug 16, 2019 (Thomson StreetEvents) -- Edited Transcript of FibroGen Inc earnings conference call or presentation Thursday, August 8, 2019 at 9:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Christine L. Chung

FibroGen, Inc. - SVP of China Operations

* Elias Kouchakji

FibroGen, Inc. - SVP of Clinical Development, Drug Safety & Pharmacovigilance

* K. Peony Yu

FibroGen, Inc. - Chief Medical Officer

* Karen L. Bergman

FibroGen, Inc. - VP of IR & Corporate Communications

* Pat Cotroneo

FibroGen, Inc. - Senior VP of Finance & CFO

* Thomas B. Neff

FibroGen, Inc. - Founder, Chairman & CEO

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Conference Call Participants

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* Difei Yang

Mizuho Securities USA LLC, Research Division - Executive Director of Americas Research

* Edwin Zhang

* Geoffrey Craig Porges

SVB Leerink LLC, Research Division - Director of Therapeutics Research, MD & Senior Biotechnology Analyst

* Joel Lawrence Beatty

Citigroup Inc, Research Division - VP & Analyst

* Michael Jonathan Yee

Jefferies LLC, Research Division - Equity Analyst

* Nirav Shelat

Piper Jaffray & Co

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Presentation

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Operator [1]

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Welcome to the FibroGen's Second Quarter 2019 Financial Results Conference Call. My name is Adrianne, and I'll be your operator for today's call. (Operator Instructions) Please note this conference is being recorded.

I'll now turn the call over to Karen Bergman. Karen Bergman, you may begin.

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Karen L. Bergman, FibroGen, Inc. - VP of IR & Corporate Communications [2]

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Thank you, Adrianne. Good afternoon, everyone. And thank you for joining our call. Today, we are reporting financial results and corporate update for the second quarter of 2019. Joining me today on the call are Mr. Tom Neff, Chairman and Chief Executive Officer; Dr. Peony Yu, Chief Medical Officer; Ms. Chris Chung, Senior Vice President of China Operations and Managing Director, FibroGen China; Dr. Elias Kouchakji, Senior Vice President, Clinical Development, Drug Safety and Pharmacovigilance; and Mr. Pat Cotroneo, Chief Financial Officer. Following our prepared remarks, Tom will discuss upcoming milestones and we will open the call to Q&A.

During this call, we may make forward-looking statements regarding our business, including our collaborations with AstraZeneca and Astellas; financial guidance; the initiation, enrollment, design, conduct and results of clinical trials; 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2018, and to our quarterly report on Form 10-Q for the quarter ended June 30, 2019, filed with the Securities and Exchange Commission. Copies of these filings may be found in the Investors section of our website. We undertake no obligation to update any forward-looking statement whether as a result of our new information, future developments or otherwise.

The format for today's call includes remarks from FibroGen's management team, and then we'll open the lines to take your questions. The press release reporting our financial results and business update and a webcast of today's conference call can be found on the Investors section of FibroGen's website at www.fibrogen.com. The webcast will be available for 2 weeks from today's date.

And with that, I'd now like to turn the call over to our CEO, Tom Neff.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [3]

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Thank you, Karen. Welcome everyone, and thank you for joining us. Let's start with our anemia program. We are pleased to report that in our pre-NDA meeting with the FDA regarding roxadustat, we reached an agreement with the agency on the content of the NDA including the cardiovascular safety analysis. This is for both the dialysis and nondialysis dependent CKD populations. We previously announced that we expected the NDA submission in September or October time frame with the clarity arising from our meeting with FDA. We and our partner AstraZeneca have refined our timing to target an October submission, with the MAA for Europe to be submitted thereafter.

We recently announced the publication on July 24 of 2 articles in The New England Journal of Medicine of the pivotal studies of roxadustat China Phase III program, 1 reporting the results from China Phase III dialysis or Study 806 and the other reporting the results from China Phase III nondialysis or Study 808. We view publication by the New England Journal of these 2 pivotal studies supporting regulatory approval for roxadustat in China as validation of the scientific and medical importance, as well as the quality of clinical research for these studies.

Other updates in China, in December 2018, we announced the approval in China roxadustat for the treatment of CKD anemia and patients receiving dialysis representing the world's first approval for any HIF-PHI. We expect the nondialysis dependent or NDD portion of the CKD indication to be approved for roxadustat in the third quarter of 2019. In a few minutes Dr. Peony Yu will provide further details regarding roxadustat and Ms. Chris Chung will provide updates on China program.

Let's turn to pamrevlumab highlights for the quarter. Starting with Duchenne muscular dystrophy, we presented positive Phase II clinical findings from the first year of treatment in our ongoing study 079 at the Parent Project Muscular Dystrophy or PPMD 2019 Annual Conference in June. Our study suggests pamrevlumab has the potential treatment benefits on heart function, lung function and muscle function in DMD patients. We shall be seeking guidance from the FDA on the design of a Phase III program.

For the treatment of idiopathic pulmonary fibrosis, or IPF, we initiated patient dosing in the ZEPHYRUS Phase III randomized, double-blind, placebo-controlled study of pamrevlumab with the primary endpoint of change of forced vital capacity or FVC over 52 weeks. We are enrolling more than 550 patients in this study and we expect to have more than 175 study sites globally.

Turning to pancreatic cancer. This disease is characterized by a high degree of growth of fibrosis characterized as desmoplasia, which is related to extensive CTGF expression. As an anti-CTGF agent, pamrevlumab has the potential to have a meaningful effect on pancreatic cancer. We are preparing to initiate patient dosing in the LAPIS study of Phase III randomized, double-blind, placebo-controlled study of pamrevlumab as a neoadjuvant therapy for patients with unresectable locally advanced pancreatic cancer or LAPC.

Later, on this call, Dr. Elias Kouchakji will discuss the DMD data presented at the PPMD conference and our IPF and pancreatic cancer Phase III trials in more detail. I have a few brief corporate and financial updates for the quarter. Our Chief Financial Officer, Pat Cotroneo, will provide further detail on finance later on the call. In the second quarter, we reported $116 million in net income or $1.34 per basic share or $1.26 per diluted share in EPS. As of June 30, 2019, FibroGen had $686.1 million in cash.

We are privileged to welcome Ms. Suzanne Blaug as a member of FibroGen's Board of Directors. Suzanne is an experienced industry executive and advisor whose deep knowledge and critical commercial marketing and strategic planning experience will be invaluable as we advance our multiple late stage products.

I would now like to ask Dr. Peony Yu to provide updates on the anemia programs. Peony, please go ahead.

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K. Peony Yu, FibroGen, Inc. - Chief Medical Officer [4]

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Thank you, Tom. Roxadustat is the first HIF-PHI for treatment of CKD anemia. And it is the largest known CKD anemia program. More than 10,000 CKD patients from 50 countries participated in our global Phase III studies. Over 8,000 of these patients are included in the dialysis or nondialysis pool for MACE analysis for the US and MACE Plus analysis for Europe as primary cardiovascular safety endpoint.

As stated by our US partner AstraZeneca, our Phase III results confirmed the cardiovascular safety of roxadustat. Together with our partners, AstraZeneca and Astellas, we recently had a very good pre-NDA meeting with the FDA on roxadustat. We reached agreement with the FDA on our proposed pool MACE analysis in dialysis and in nondialysis. We are pleased with the agreement for nondialysis as it includes an approach to account for the differential dropout between roxadustat and placebo. With agreement on NDA content and format, we are moving as quickly as we can towards submission. We do have a large submission, at this time, we are targeting October of this year.

For Europe, we are working with Astellas, our EU partner, on MAA preparation based on the Phase III results in the roxadustat program. Astellas has recently updated MAA submission timeline from calendar year 2019 to their fiscal year 2019, which ends March 2020. We look forward to present Phase III study results in upcoming medical conferences such as ASN in November and in peer-reviewed journals. In Japan, Astellas submitted NDA for roxadustat treatment of anemia in dialysis-dependent CKD patients in last September. The PMDA's regulatory decision on this NDA is expected this year.

We and our partners AstraZeneca and Astellas are working together on expanding anemia treatment beyond CKD. In MDS, we have 2 ongoing clinical studies, a Phase III US global study in transfusion-dependent MDS patients and a Phase II/III study in nontransfusion-dependent MDS patients in China.

We are now starting a Phase II US study of roxadustat for treating chemotherapy-induced anemia on track for starting this quarter.

I now like to turn the call back over to Tom.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [5]

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Thank you, Peony. Next, I'd like to ask Chris Chung, who heads our China operations to offer some comments on roxadustat in China, our country of first approval. Chris, please go ahead.

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Christine L. Chung, FibroGen, Inc. - SVP of China Operations [6]

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Thanks, Tom. It's been a productive quarter on the China front. We have been projecting a Q3 commercialization date. Certification of our commercial API plant in Cangzhou, the gating factor, was achieved in May. I'm pleased to share the news with everyone that the first batches of commercial roxadustat capsules have been shipped. We all know that affordability for our patients is critical to widespread market adoption. Government reimbursement for roxadustat is something that we're actively pursuing. Historically, it has taken a number of years after NDA approval before a drug is reimbursed by the Chinese government.

We have made this as a base case assumption. Until we secure government reimbursement, the near-term market adoption rate will be slow. Nonetheless, we believe we have a strong case for roxadustat to be included for reimbursement sooner rather than later, given the scope of the unmet medical need, the novel treatment pathway, the strength of our clinical data, and the fact that access to innovative medicines is a top national priority. It is still too early to tell if roxadustat will be included in the 2019 reimbursement cycle, but we should have more clarity by the end of this year.

If reimbursement is not obtained, we will have drug available for patients in the self-pay market, and our market development efforts with AstraZeneca will continue to advance. We remain highly optimistic about the market potential for roxadustat in China. We continue to build momentum with our investments in marketing, market access and medical affairs and the AstraZeneca field sales force is being scaled up to address the size of the market opportunity.

I look forward Tom to keeping everyone updated in the exciting months ahead. Now back to you, Tom.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [7]

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Thank you, Chris. Moving on to pamrevlumab, Dr. Elias Kouchakji will provide a few more details on the Phase II data update we recently presented at the PPMD Annual Conference in July, as well as the progress in our Phase III studies in IPF and LAPC. Elias, please go ahead.

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Elias Kouchakji, FibroGen, Inc. - SVP of Clinical Development, Drug Safety & Pharmacovigilance [8]

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Thank you, Tom. I would like to start with our work in Duchenne muscular dystrophy. As Tom mentioned, we presented positive Phase II primary clinical data of the first full year of treatment in all 21 nonambulatory Duchenne muscular dystrophy patients at the PPMD 2019 Annual Conference in June, notably, on cardiac function fibrosis and muscle function.

It is important to note the decline in cardiac function is the leading cause of mortality in nonambulatory Duchenne muscular dystrophy. In this study, we showed an increase in estimated mean change from baseline and left ventricular ejection fraction, also known as LVF, of positive 0.29% versus what is an expected decline in LVF. Additionally, a correlation between improvement in LVF and reduction in cardiac fibrosis was presented. Neither of these results has been previously reported in scientific literature.

Speaking of the loss of strength in nonambulatory Duchenne muscular dystrophy patient, we know this will eventually lead to the further reduction of their quality of life. The results of upper arm muscle function and muscle fibrosis patch showed mean change in PUL from baseline of a decline of 1.53, demonstrating a potential meaningful reduction in the rate of the decline in comparison to the published data. Additionally, the results of estimated mean change in the grip strength score were positive and showed a score increase in both dominant and in nondominant hands at 1 year of treatment with pamrevlumab. The grip strengthen in this population typically is expected to decline. In this study, pamrevlumab was well tolerated. We are particularly excited by this result in the nonambulatory population, which to-date has been the subject of extremely limited clinical trials. We shall be seeking guidance from the FDA on the design of our Phase III program.

Moving to our program in IPF. We have initiated dosing in ZEPHYRUS Phase III study in IPF, a randomized, double-blind placebo-controlled Phase III clinical trial with the primary endpoints of a change in forced vital capacity, FVC, from baseline in approximately 565 patients to confirm efficacy and safety results we have seen in our Phase II studies. ZEPHYRUS Phase III study is similar in design to our Phase II placebo-controlled study, PRAISE. The objective is to confirm the positive efficacy and safety results previously reported in PRAISE, in which pamrevlumab treatment attenuated the progression of IPF and was well tolerated.

Last but not least, I will be turning to the pancreatic cancer study. We are screening patient for our LAPIS Phase III study in pancreatic cancer, a randomized, double-blind, placebo-controlled Phase III study evaluating pamrevlumab as a neoadjuvant therapy for unresectable locally advanced pancreatic cancer. This study will enroll approximately 260 patients on standard of care. A standard of care is defined as a treatment to gemcitabine and nab-paclitaxel, and will be randomized to either pamrevlumab or placebo. In this study, we will be evaluating the rate of resection and overall survival. We believe that pamrevlumab can provide a new therapy to patient with IPF, LAPC and Duchenne muscular dystrophy, each of which are serious and fatal disease.

Thank you for listening and now I'll turn the call back to Tom.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [9]

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Thank you, Elias. Our Chief Financial Officer, Pat Cotroneo, will now walk through the financial results for the second quarter of 2019 and our financial outlook through fiscal year 2019. Pat, please proceed.

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Pat Cotroneo, FibroGen, Inc. - Senior VP of Finance & CFO [10]

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Thank you, Tom. As announced today, total revenue for the quarter ended June 30, 2019, was $191.6 million as compared to $44 million for the second quarter of 2018. For the same period, operating expenses were $78.7 million and net income was $116 million or $1.34 per basic share and a $1.26 per diluted share as compared to operating expenses of $67.2 million and the net loss of $23.4 million or $0.28 per basic and diluted share for the second quarter last year.

Included in operating expenses for the quarter ended June 30, 2019, was an aggregate noncash portion totaling $21.9 million, of which $17.6 million was a result of stock-based compensation expense, as compared to an aggregate noncash portion totaling $15.2 million, of which $13.2 million was a result of stock-based compensation expense for the same period in the prior year.

In accordance with US GAAP, in the second quarter, we are including in our revenue recognition methodology a total of $180 million comprised of $50 million for an anticipated milestone from AstraZeneca relating to the filing of the US NDA and the $130 million in anticipated milestones from Astellas in connection with the EU MAA filings. Out of the $180 million, $171.1 million was recognized in the current quarter and the remaining balance will be recognized in future periods. Under the current US GAAP revenue recognition guidelines, we are required to include estimated consideration from milestones in the determination of revenue recognition in the period that milestone achievement becomes probable. The timing of when the payments related to these not milestones will be remitted to FibroGen depends upon when the milestones are actually achieved.

As noted earlier on this call, timing for the NDA filing is targeted for October of this year, and we expect the Astellas MAA submission to occur in the second half of the Astellas 2019 fiscal year with MAA filing in early 2020. Previously, we had reported as any cash range of $720 million to $730 million. Adjusting for our latest forecast, we would increase our 2019 ending cash estimate to $740 million to $750 million. Given that the milestone payments could move into next year, I'd like to provide additional scenarios. Assuming that the EU MAA filing is done and completed in 2020 and the $130 million and associated milestones are paid at that time, our current anticipated ending 2019 cash range will be approximately $610 million to $620 million. This ending cash range assumption also includes a $50 million milestone from AstraZeneca for the filing of the US NDA, which should occur within 60 days after NDA submission. At June 30, 2019, FibroGen had $686.1 million in cash, restricted time deposits, cash equivalents, investments and receivables.

Thank you, and I would now like to turn the call back over to Tom.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [11]

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Thank you, Pat. Let's wrap up by pointing out to some key events ahead. For roxadustat in the US, we anticipate submitting our NDA -- to the US FDA for the treatment of anemia associated with dialysis-dependent and nondialysis-dependent CKD in October 2019. We expect the EU MAA to be submitted by our partner Astellas thereafter. In China, we expect to add nondialysis-dependent CKD patients to the roxadustat label in Q3 2019. We also expect to initiate our Phase II study of roxadustat for the treatment of chemotherapy-induced anemia in this quarter.

For pamrevlumab, we are pushing forward with 3 indications in the mid- to late-stage development and we are looking forward to keeping you updated on those activities including in IPF, progression of our ZEPHYRUS Phase III IPF study and locally advanced pancreatic cancer or LAPC initiation and progression of our LAPIS Phase III study.

In DMD, having reported on the first year of treatment and our ongoing Phase II DMD study and now advancing our patients through their second third and fourth years of treatment, we plan to seek guidance from the FDA on the design of a Phase III program.

With that, let me turn this back to Karen to begin the question-and-answer session. Karen, please go ahead.

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Karen L. Bergman, FibroGen, Inc. - VP of IR & Corporate Communications [12]

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Thank you, Tom. Adrianne, please open up the line for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

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Karen L. Bergman, FibroGen, Inc. - VP of IR & Corporate Communications [2]

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We are set for our first question; I think it's from Michael Yee.

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Michael Jonathan Yee, Jefferies LLC, Research Division - Equity Analyst [3]

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Two questions. One is for Tom, what were the 2 or 3 most important things that you guys discussed with the FDA or topics or key issues regarding approvability in your meeting? And then, separately, regarding the statistical plan, there seems to be a concern about noninferiority on MACE, not MACE Plus, but MACE. Can you talk to your confidence around the statistics and whether that's an issue for the FDA? Thanks so much.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [4]

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Peony, go ahead.

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K. Peony Yu, FibroGen, Inc. - Chief Medical Officer [5]

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Hi, Mike. This is Peony. In the FDA meeting, we have accomplished what we intended for the meeting. You asked about the important agreement or achievement. I will name that. We have gained FDA's agreement on our proposal for a single primary safety cardiovascular endpoint analysis for dialysis, as well as cardiovascular safety primary endpoint for nondialysis.

And in terms of the way that the time to MACE primary endpoint is being analyzed in nondialysis, this will account for differential drop out between our drug and placebo, whereas you know that because placebo doesn't work in treating anemia, placebo patients had a tendency to drop out earlier. And we have reached agreement on statistical method that accounts for that. You have asked about our confidence on noninferiority on MACE. At this time, with these understanding, our level of confidence is very high and we do believe as AstraZeneca has stated that our Phase III results confirm cardiovascular safety of roxadustat in the CKD population in both dialysis and nondialysis.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [6]

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And Mike, I would add that what I saw was that we gained a lot of clarity across the board and both our team and AZ's team reflected a very high degree of confidence coming out of the meeting. So, there is detailed planning right now, how to get everything done in October early and so everybody is aggressively moving ahead.

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Michael Jonathan Yee, Jefferies LLC, Research Division - Equity Analyst [7]

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Perfect. Thank you for those comments in and around the statistics and your confidence.

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Operator [8]

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And the next question comes from Geoff Porges from SVB Leerink.

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Geoffrey Craig Porges, SVB Leerink LLC, Research Division - Director of Therapeutics Research, MD & Senior Biotechnology Analyst [9]

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And I have to ask some follow-up questions. Could you confirm whether you have written minutes from the meeting with the agency? And then, Peony, you mentioned the exposure adjusted analysis of the time to first MACE event but could you -- we haven't seen that analysis. But, presumably you have run it already. Can you tell us either what the absolute rates are when you adjust for exposure between the 2 groups and nondialysis group or at least what range, where they are in terms of relation to each other? And then, could you explain the amendment in your Q that the European regulator is going to look at MACE as well as MACE Plus. Is that the result of a conversation or meeting and does that make you less confident or any change to your confidence about the European application?

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [10]

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Geoff let me deal with the last issue first. There's no back story on the MACE, MACE Plus for Europe that we're aware of. So I think just take at face value. Peony, go ahead and address Geoff's other questions please.

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K. Peony Yu, FibroGen, Inc. - Chief Medical Officer [11]

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Geoff, we had our FDA meeting towards the end of July. So usually it will take a little bit longer before we received a meeting minutes. What I'm reporting to you is based on our exchange with the FDA and there was sufficient clarity for us to be sharing what we had just said. Okay?

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Geoffrey Craig Porges, SVB Leerink LLC, Research Division - Director of Therapeutics Research, MD & Senior Biotechnology Analyst [12]

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Great, thanks.

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Operator [13]

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And our next question comes from Joel Beatty from Citi.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [14]

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Recently at the end of July there was a New England Journal of Medicine publication and Phase III results from China. There was also an editorial in there that generally seems favorable, talked about hyperkalemia and the studies with a little bit of reservation. Would you be able to address that, the potential to use roxadustat in patients with hyperkalemia? And then, also discuss from the US EU Phase III results if that was a finding that seemed to show up?

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [15]

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So, Joel, as a starting point here, the editorial work and such with these 2 articles for New England Journal was quite aggressive, intensive and so on, for about a month. And the topic of safety discussion came up right at the end at their editorial board's suggestion. So it was a little surprising. I think Peony can explain how we see it. Go ahead Peony.

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K. Peony Yu, FibroGen, Inc. - Chief Medical Officer [16]

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Thanks, Tom. That was intensive. So I believe that we had previously discussed hyperkalemia in or around November after ASN last year. And coming back to New England Journal, yes, it was reported that there was an apparent imbalance of hyperkalemia reported as adverse events by investigators in the 2 China Phase III studies. Now, in New England Journal supplement for these 2 manuscripts also showed that there is no imbalance in the hyperkalemia when we reported the analysis based on central lab data. Just as a background on CKD patients, elevation of blood potassium level is consistent and characteristic of CKD patient populations, because the diseased kidneys are not able to properly regulate potassium levels and acid base balance.

To address your questions on the larger Phase III program that has been reported and that indeed is another -- is a good way to further look into this question. So, from what we have seen the reported incidence rates of hyperkalemia adverse events were comparable between roxadustat and comparator arms in the dialysis and the nondialysis studies. Also, the analyses of potassium central lab values also suggest, there isn't a hyperkalemia risk with the use of roxadustat. We look forward to presenting the results from these much larger and longer Phase III studies in upcoming medical conferences.

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Operator [17]

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And our next question comes from Difei Yang from Mizuho.

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Difei Yang, Mizuho Securities USA LLC, Research Division - Executive Director of Americas Research [18]

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Hi. Good afternoon, and thanks for taking my question. On the roxadustat NDA filing, would you remind us who's primarily responsible to submit the NDA, is it AstraZeneca or is it FibroGen?

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [19]

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Hello. I will have Peony address this, please.

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K. Peony Yu, FibroGen, Inc. - Chief Medical Officer [20]

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Hi Difei. Good to hear from you. Yes, AstraZeneca is a very good partner in the US. In terms of roles and responsibility, FibroGen is the IND holder. And we are also the party responsible for the final, for putting together the file and submitting to the FDA. In terms of ways of working together, we have a highly collaborative relationship with both of our partners. And we have frequent communication as well as generating the study results together.

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Difei Yang, Mizuho Securities USA LLC, Research Division - Executive Director of Americas Research [21]

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Okay, thank you for the clarification. Now changing subject to IPF, you have started recruiting for the Phase III, would you remind us when should we be expecting top-line results?

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [22]

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Elias, please go ahead.

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Elias Kouchakji, FibroGen, Inc. - SVP of Clinical Development, Drug Safety & Pharmacovigilance [23]

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Difei, its Elias. We just started enrolling in this study. This study will have to enroll closer, a little bit over 550 patients. This is going to take a little time to enroll as we have seen in all IPF studies. When the last patient is enrolled and have a 1-year of treatment, this is what we consider the end of the study and at that time when we would be possibly can see this data between the late 2022 and early 2023.

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Operator [24]

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And our next question comes from Adam Walsh from Stifel.

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Edwin Zhang, [25]

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Hi, this is Edwin on for Adam. Congrats again on the progress made in the last quarter. So I have a few questions, if I may. My first question is on incident dialysis. So what is your filing and commercial strategy over there? So based on the efficacy and safety data, do you expect this incident dialysis patient population will be defined and listed in the roxa label if approved. And similarly, can you also comment the nondialysis study. So what is your strategy and view there? And I have a follow up questions.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [26]

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Peony, if you can address incident dialysis first.

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K. Peony Yu, FibroGen, Inc. - Chief Medical Officer [27]

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Thank you for the question. So in terms of our submission, we are seeking approval for treating CKD anemia in all dialysis as the primary patient indicate -- as the primary indication and also nondialysis. Now for incident dialysis, we do believe that this is a very important subgroup in -- which is part of all dialysis. The reason that we say that and also have this discussion supported -- this discussion with our medical reviewer is that, oftentimes anemia therapy starts around the time of dialysis initiation and we continue to follow the patient during the course of treatment anemia drug as well as during the course of dialysis. And now given the importance of this information for prescribing physician, we do feel that information on the outcome of the incident dialysis patients are important to prescriber and we expect this to have positive impact on commercial potentials. Our FDA medical reviewer has suggested additional analysis and whether -- and as far as labeling that will be a review issue.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [28]

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The second question was about NDD, is that correct?

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Edwin Zhang, [29]

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Yes.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [30]

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Okay. So Peony, please address NDD. Can you restate your full question for NDD?

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Edwin Zhang, [31]

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Similar to the incident dialysis population, what is your filing and the commercial strategy? And also, maybe comment on the potential competition because you set a higher bar in safety if you show non-inferiority to placebo.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [32]

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Peony, go ahead.

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K. Peony Yu, FibroGen, Inc. - Chief Medical Officer [33]

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Yes. So we are very pleased with the agreement on the primary safety analysis of our primary cardiovascular safety endpoint in NDD. We had -- because when we are considering the value of a drug, whether from a medical point of view and commercial point of view, is looking at benefit and risk. And we are very pleased with the positive efficacy results for anemia therapy not only just to keep hemoglobin level up, but also reduce blood transfusion risk as well as attenuation of renal progression that we have previously reported.

Now, on the safety side, the ability to demonstrate a drug is as safe as placebo, which is a very high bar because placebo is considered -- to give the drug an opportunity to show how safe it is based on its own merit. And the fact that our drug has a placebo comparator and also it is orally administered, which makes it accessible to patients, we believe that we will, or we will have an opportunity to address the unmet medical need and expand the market beyond what ESA is able to do as -- and we both we and our partner AstraZeneca believe that the nondialysis market is larger than that of the dialysis market.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [34]

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Potential market in nondialysis is larger than the current market in dialysis. I think we will probably decline to comment on the competitive aspects. Did you have any other questions?

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Operator [35]

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He has left the queue.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [36]

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Thank you. Go ahead with next question please.

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Operator [37]

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We do have a question from Danielle Brill from Piper Jaffray.

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Nirav Shelat, Piper Jaffray & Co [38]

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Hey everyone. Thank you for taking my question. This is Nirav on for Danielle. I just had 2, regarding a question that was asked earlier. I'm not sure if it was answered. Would you be able to tell us with the data that you currently have and this statistical analysis that you're doing what the absolute rates where, when you adjust for the drop outs?

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [39]

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We won't be able to discuss that until later in the process.

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Nirav Shelat, Piper Jaffray & Co [40]

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I see, okay, thank you. And the other question I had was regarding the IPF study. I was wondering with the enrollment currently ongoing, if you could give us some color on the geography of the sites? And how many sites are in the United States versus ex-US and if we should expect a significant amount of patients to come ex-US.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [41]

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These are targets now, we haven't accomplished this yet, so Elias, please go ahead and explain.

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Elias Kouchakji, FibroGen, Inc. - SVP of Clinical Development, Drug Safety & Pharmacovigilance [42]

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Sure. The target is -- the majority would be from the US and this is globally as is other similar product, which is running globally. We are going in the EU and all other regions, Southeast Asia and the potential number of patients coming from the US versus ex-US. We still are targeting to have a very large number from the patients who come from US at the same time. We are seeing this as a very good number of sites that are enrolling and eager to be part of our study.

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Nirav Shelat, Piper Jaffray & Co [43]

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Thank you for the call, I really appreciate it.

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Operator [44]

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And this concludes the question-answer-session. I'll now turn the call back over to Tom Neff for final remarks.

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Thomas B. Neff, FibroGen, Inc. - Founder, Chairman & CEO [45]

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Let me say it's incredibly gratifying to see the advancement of roxadustat and pamrevlumab programs, and the recognition of their potential by the medical community as seen by the recent publications of our various clinical results. This is a testament to years of hard work on the part of our dedicated employees. We cannot thank enough to the patients and to their families and to physicians and to investigators, who have and who are participating in our studies. We all have the same goal of expanding therapeutic options for patients who need them.

Thank you also to our shareholders, who have followed our story and are seeing the advancement and development of ideas born in our research lab. I'd like to wish everyone a good afternoon and evening. Thank you for joining our call.

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Operator [46]

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