Slide 1: Discussion Materials
Exhibit 99.1 Discussion Materials May 2015
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation, the accompanying modules, and in each case the oral commentary contain “forward-looking” statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, the accompanyin
Slide 3: Investment Highlights
Investment Highlights • Three broad technology platforms generating multiple product candidates • Roxadustat – a novel oral treatment for anemia in Phase 3 • Targeting the multi-billion dollar global anemia market • IP protection expected through 2033 and potentially beyond • >1400 subjects evaluate
Slide 4: Roxadustat - Post-IPO Highlights
Roxadustat - Post-IPO Highlights • Program on schedule to submit regulatory filings in 2016 for China and 2018 for US • Launched seven Phase 3 trials for US and European filing • Two Phase 3 approval trials in China currently expected to start H2 2015 • Completion of three scheduled reviews by data
Slide 5: China Program - Post-IPO Highlights
China Program - Post-IPO Highlights • Roxadustat CTA technical review underway • Phase 3 first patient first visit expected H2 2015 • China NDA submission expected in 2016 • China NDA review expected in 2017 5
Slide 6: FG-3019 - Post-IPO Highlights
FG-3019 - Post-IPO Highlights • IPF – Study 067 – Protocol amended to include subjects previously treated with approved IPF therapies – Expansion of study sites to include certain European and former Commonwealth countries – Enrollment expected to complete late 2015; top-line data in late 2016 • Pan
Slide 7: Financial - Post-IPO Highlights
Financial - Post-IPO Highlights • IPO net proceeds of $171.8 M • Milestone and non-contingent license payments of approximately $200 M expected through Q2 2016 • Cap of $116.5 M on shared costs agreed upon with AstraZeneca for roxadustat CKD anemia development (ex-China) expected to be reached in Q4
Slide 8: Management Team
Management Team THOMAS NEFF Chief Executive Officer PAT COTRONEO Chief Financial Officer FRANK VALONE, MD Chief Medical Officer K. PEONY YU, MD VP, Clinical Development CHRIS CHUNG Exec Director & China Project Leader LEANNE PRICE, JD VP, Intellectual Property & Corp Strategy R. WAYNE FROST, PHARM D
Slide 9: Our Platforms and Product Portfolio
Our Platforms and Product Portfolio HIF PLATFORM PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Roxadustat (HIF-PH Inhibitor for anemia) • United States / Europe • China • Japan FG-6874 (HIF-PH Inhibitor; Stem Cell Mobilization) FG-8205 (Selective HIF-PH Inhibitor for heart failure after myocardial infarction)
Slide 10: Development Timeline
Development Timeline 2014 2015 2016 2017 1H 2H 1H 2H 1H 2H 1H 2H Initiate AZ Studies Complete Enrollment Global NDD&DD Publications Ph2 Complete Data Cut for EU Incident Dialysis NDD & DD Enrollment NDD Study Database Lock US/ Initiate FGN Study US, Asia Pacific, Stable DD Study ROW Latin America Da
Slide 11: Roxadustat
FIBROGEN Roxadustat
Slide 12: Anemia 101
Anemia 101 THE CONDITION RED BLOOD CELL CREATION (ERYTHROPOIESIS) Reduced Oxygen-Carrying Capacity of Blood - Reduces Availability of Iron for RBC Production ANEMIA IN CKD Dialysis & Pre-Dialysis INCREASED MORTALITY 12
Slide 13: Roxadustat Activates a Natural Pathway to Increase Red Blood Cell Production
Roxadustat Activates a Natural Pathway to Increase Red Blood Cell Production 1 HIF-PH Enzymes EPO Within or Near Degrades Rapidly Physiological Range NORMAL OXYGEN Degradation Iron Transport to the HIF Bone Marrow and Hemoglobin (Hb) Synthesis HIF Iron Absorption LOW OXYGEN HIF HIF (e.g. High Altitu
Slide 14: Roxadustat Achieves Target Hb with Physiologic EPO Cmax Levels
Roxadustat Achieves Target Hb with Physiologic EPO Cmax Levels 6,000 5,000 ESA5 EPO Cmax (U.S. ESA Label: (mIU/mL) 4,000 Hb 10 to 11 g/dL) 3,000 1 2,000 ROXADUSTAT PHYSIOLOGICAL (Target Hb 11 to 13 g/dL) ADAPTATION 1,000 0 2 0.99 1.20 1.60 Altitude Blood Loss 3 Pulm 20 44 93 197 0.16 3.86 mg/kg/dose
Slide 15: ESAs Ineffective or Require High Doses in Presence of Inflammation in Preclinical Model
ESAs Ineffective or Require High Doses in Presence of Inflammation in Preclinical Model Normal Animals Anemia of Inflammation • Roxadustat Increased Hb • Roxadustat Increased Hb • Aranesp® Increased Hb but Reduced • Aranesp® or IV Iron Ineffective for Mean Cell Volume (Depletes Iron) Anemia of Infla
Slide 16: Roxadustat Reduces Hepcidin
Roxadustat Reduces Hepcidin Decreased Hepcidin Improves Iron Availability and Reduces ESA Resistance CKD-DD Patients Previously Treated with CKD-DD Newly Initiated Dialysis EPO and Randomized (Study 040a) (Study 053) (Conversion, ESA Hyporesponders) 400 p <0.0001 p=0.038 1 100 350 n=52 Mean 300 Mean
Slide 17: Hb Correction and Maintenance by Roxadustat Appears Independent of Inflammation (Study 053)
Hb Correction and Maintenance by Roxadustat Appears Independent of Inflammation (Study 053) • As shown by CRP (marker of inflammation) • Hb correction appears independent of inflammatory state • Dose requirement for Hb maintenance appears independent of inflammatory state • Greater reduction in hepc
Slide 18: Phase 2 Program Conducted Across Different CKD Populations
Phase 2 Program Conducted Across Different CKD Populations DOSE TIER STUDY PATIENTS WEEKS LEVELS WEIGHTS CONTROL KEY RESULTS Placebo-Controlled Pre-Dialysis 017 Dose Range 116 4 4 No Placebo • Reduction in Hepcidin Finding, NDD • Dose-dependent Increase in Hb 047 Pre-dialysis 91 8 2 3 Placebo • Enco
Slide 19: Study 017: Placebo-Controlled Proof of Concept Study in Pre-Dialysis
Study 017: Placebo-Controlled Proof of Concept Study in Pre-Dialysis DESIGN DESIGN Mean (± SE) hbmax (g/dL) • Anemic Pre-dialysis Patients not Receiving ESA 3.0 % Hb Responders • Randomized to Placebo or 100% Roxadustat, BIW or TIW 2.5 91 % 100% – 4-week Dose Ranging Study 80% Evaluating 4 Weight-ba
Slide 20: Study 047: Placebo-Controlled Study in Pre-dialysis
Study 047: Placebo-Controlled Study in Pre-dialysis Mean (±SE) Hb Change from BL (g/dL) DESIGN 12 High Dose: 1.77 mg/kg (n=31) • Anemic Pre-dialysis Patients Low Dose: 1.37 mg/kg (n=30)* not Receiving ESA Placebo (n=30) 11 • Randomized to Placebo or Roxadustat TIW – Two Tier Weight-based Doses 10 –
Slide 21: Studies 048 and 040a: ESA Comparator Study in Stable Dialysis Patients
Studies 048 and 040a: ESA Comparator Study in Stable Dialysis Patients when Switched from Epoetin (Conversion) • Hemodialysis Patients with Hb Corrected on Stable Doses of ESA DESIGN - For Study 048, approximately 50:50 split between SC and IV Studies 048 and 040 • Randomized to Roxadustat TIW or Co
Slide 22: Study 040b: ESA Comparator Study in Stable Dialysis Patients
Study 040b: ESA Comparator Study in Stable Dialysis Patients when Switched from Epoetin (Conversion) DESIGN – Stable Dialysis Mean (±SE) Hemoglobin (g/dL) Conversion from ESA • Hemodialysis Patients with Hb Roxadustat (n=61) Corrected on Stable Doses of ESA • Randomized to Roxadustat TIW or Continua
Slide 23: FibroGen
FIBROGEN
Slide 24: Study 041: Dose Finding in Pre-dialysis
Study 041: Dose Finding in Pre-dialysis Different Targets, Different Correction Rates, Single Maintenance Algorithm Mean (±SD) Hemoglobin (g/dL) DESIGN 13.0 Target Hb • CKD Patients not on Dialysis Cohorts A,B,E & F • Roxadustat Starting Doses 12.5 - TIW or BIW - Tier Weight Dosing: 3 Sizes 12.0 Tar
Slide 25: Study 053: Roxadustat Corrects Anemia in Newly Initiated Dialysis Patients without IV Iron
Study 053: Roxadustat Corrects Anemia in Newly Initiated Dialysis Patients without IV Iron DESIGN Mean (±SE) Hemoglobin (g/dL) • Incident Dialysis (Newly Initiated Dialysis) Patients with Low Hb Levels and not on ESAs • All Received Roxadustat • Comparison of Treatment Response Under Different Iron
Slide 26: Conclusions: Phase 2 Studies
Conclusions: Phase 2 Studies • Evaluated Broad Range of CKD Patient Population: Stable Dialysis, Incident Dialysis and Nondialysis; ESA Hyporesponders • In Dialysis and Nondialysis: Consistent, Dose-Dependent Hb Response with Roxadustat • In Nondialysis: Both Tiered and Fixed Dosing Regimens Produce
Slide 27: Roxadustat Safety Review
Roxadustat Safety Review SAFETY • No Overall Safety Signal OBSERVATIONS – An independent data monitoring committee reviewed data – Frequency and type of AEs expected in CKD patients IN COMPLETED PHASE 1 & 2 • No Cardiovascular Signal STUDIES • Lowers Cholesterol Levels Roxadustat Exposure ~1,100 Sub
Slide 28: Treatment-Emergent Serious Adverse Events
Treatment-Emergent Serious Adverse Events Placebo-Controlled Phase 2 Trials (Anemia correction in non-dialysis patients) Protocol 017 Protocol 047 4 Weeks 8 Weeks Roxadustat Placebo Roxadustat Placebo Number of subjects 88 28 61 30 SAEs 4 (4.5%)* 1 (3.6%) 8 (13.1%)* 4 (13.3%) Cardiovascular SAEs 0 1
Slide 29: Roxadustat Submissions for Marketing Approvals: US, Europe, and China
Roxadustat Submissions for Marketing Approvals: US, Europe, and China • Indication – Treatment of Anemia Associated with Chronic Kidney Disease (CKD) in Patients on Dialysis and Not on Dialysis • Primary Efficacy Endpoints - Based on Hemoglobin (Hb) Measurements – Change in Hb from Baseline, or % Hb
Slide 30: Roxadustat Phase 3 Program
Roxadustat Phase 3 Program STUDY RANDOM- STUDY STUDY NUMBER COMPARATOR IZATION N LOCATIONS CHINA EUROPE US SPONSOR PHASE 3 STUDIES TO SUPPORT REGULATORY APPROVAL Stable Dialysis CL-613 1 Epoetin /Darbe 376/200/174 750 EU, MEA 3 36+ wks 52+wks Astellas FG-064 1 Epoetin 1:1 Up to 750 US+/-Global 36+ w
Slide 31: Roxadustat Has Potential to Address Unmet Need in Multiple Markets
Roxadustat Has Potential to Address Unmet Need in Multiple Markets Secondary CKD Disease CKD DIABETES HYPERTENSION CANCER INFLAMMATORY Dialysis Pre -Dialysis 36% Anemic¹ 20% Anemic¹ Myelodysplasia IBD, Lupus, RA, Chemotherapy etc. Induced Anemia Safety Issues Limitations (Higher ESA doses ESAs Not F
Slide 32: Potential Multiple Global, Multi-Billion Dollar Markets for Anemia
Potential Multiple Global, Multi-Billion Dollar Markets for Anemia Secondary CKD Disease CKD DIABETES HYPERTENSION CANCER INFLAMMATORY Dialysis Pre-Dialysis 36% Anemic¹ 20% Anemic¹ Myelodysplasia IBD, Lupus, RA, Chemotherapy etc. Induced Anemia 1 2 3 4 Roxadustat New Market: Re-Establish New Market:
Slide 33: Roxadustat Competitive Profile
Roxadustat Competitive Profile • Most advanced HIF-PHI in development: Global Phase 3 program underway • Extensive clinical experience: >1,100 patient exposures in Phase 1 & 2 • 3 year maximum exposure duration • Intermittent dosing • Phase 3 dosing regimen based on extensive testing in Phase 1 and
Slide 34: Study 041 – Competitive Highlights
Study 041 – Competitive Highlights Roxadustat Study 041 (pre-dialysis) Sample size 145 Completion Rate 92% Definition of Hb response Achievement of Hb 11 g/dL and Hb increase 1 g/dL Renal SAEs and/or dialysis initiation 5.5% (8) Dialysis initiation while on study 3.4% (5=4 SAEs + 1 non-SAE) With no
Slide 35: Phase 3 Dosing Regimen Optimized for Hb Effect and Convenience
Phase 3 Dosing Regimen Optimized for Hb Effect and Convenience Starting dose: non-dialysis (1 study) Roxadustat dose 70 mg Starting doses: non-dialysis and incident dialysis (3 studies and 1 study, resp.) Body weight (kg) <70 kg 70 kg Roxadustat dose 70 mg 100 mg Starting dose: stable dialysis (3 st
Slide 36: China Opportunity
China Opportunity STAGE 4 PRE-DIALYSIS • Very Sick, Highly Progression NON-DIALYSIS Anemic, Dialysis Stage to End Stage Population • Unique Positioning as a Domestic Renal • Very Limited ESA Use Chinese Company Disease • CFDA Green Pass Status • AZ, Our Commercial Partner, • Mean Hb 9.1 Achieved 2nd
Slide 37: Corneal Implants – FG-5200 (China)
Corneal Implants – FG-5200 (China) Central corneal scar covering entire pupil Most of pupil is blocked Proprietary Recombinant Human Type III Collagen • Integration of Implants with Host Tissue • Encourages Nerve Regeneration • Allows for Clearer Vision and No Rejection URGENT, • Approximately 4 to
Slide 38: Roxadustat Global Partnerships
Roxadustat Global Partnerships JAPAN, U.S., CHINA, CASH RECEIVED $ Millions EU, ETC. ROW TO DATE Equity Investment $81 $20 $101 in FibroGen Upfront, $360 $402 $360 + $220 Non-Contingent China Development & Reg. Partnership: $543 $571 $103+ $0 Milestones 50% Profit Sharing PAYMENTS TO FIBROGEN and 50
Slide 39: FG-3019: Monoclonal Antibody to Connective Tissue Growth Factor (CTGF)
FG-3019 Monoclonal Antibody to Connective Tissue Growth Factor (CTGF) 39
Slide 40: FG-3019 Improved Fibrosis in Mouse Model and in Human Disease
FG-3019 Improved Fibrosis in Mouse Model and in Human Disease Radiation-Induced Mouse Lung Fibrosis Phase 2A IPF Clinical Trial Reversal of Fibrosis by Micro-CT Imaging Reversal of Lung Fibrosis by High Resolution CT at Week 48 Improved/Stable 38 % Week Post-Irradiation Subject Improved / Stable Fib
Slide 41: Phase 2 Dose-Dependent Survival in Advanced Pancreatic Cancer
Phase 2 Dose-Dependent Survival in Advanced Pancreatic Cancer FG-3019 Combined with Gemcitabine and Erlotinib (n=75) Relationship of 1-Year Survival to Dose Relationship of Survival to FG-3019 Day-15 Plasma Levels Percent 1 Year Percent Overall Survival Survival Rate 100 35% 30% 30% 31% 31% FG-3019
Slide 42: Phase 2 Trials in IPF and Pancreatic Cancer
Phase 2 Trials in IPF and Pancreatic Cancer • Randomized placebo-controlled clinical trial • 136 patients • Naïve; previously treated; pirfenidone / nintedanib failures IPF • Key endpoints – Pulmonary function: change in FVC from baseline – Fibrosis by HRCT • Currently enrolling • Main goal: convert
Slide 43: Duchenne Muscular Dystrophy (DMD) and CTGF Blockade
Duchenne Muscular Dystrophy (DMD) and CTGF Blockade • DMD – rare hereditary disease: ~1 in 3,500 boys in the US – No FDA/EU approved treatment to date – Progressive muscle weakness and respiratory failure (age 5-18) – DMD leads to muscle fibrosis and loss of muscle function: muscles replaced by fibr
Slide 44: FG-3019 Decreased Fibrosis and Increased Muscle Strength in mdx Mice
FG-3019 Decreased Fibrosis and Increased Muscle Strength in mdx Mice FG-3019 significantly reduced collagen FG-3019 increased Isometric Force by 50% content/fibrosis in muscle (mdx mouse) (mdx mouse) 44
Slide 45: Decreased CTGF Increased Skeletal Muscle Function in mdx Mice
Decreased CTGF Increased Skeletal Muscle Function in mdx Mice CTGF hemi-zygous or FG-3019-treated mdx mice exhibited increased isometric force WT- wild type, normal mice; mdx - disease model 45
Slide 46: FG-3019 Increased Muscle Endurance in mdx Mice
FG-3019 Increased Muscle Endurance in mdx Mice 5-min treadmill exercise tolerance test: • mdx mice treated with FG-3019 stopped fewer times to rest than untreated mice (mdx-control) and were more similar to normal mice Morales, Hum Mol Genet-Suppl Data (2013) 46
Slide 47: Investment Highlights
Investment Highlights • Three broad technology platforms generating multiple product candidates • Roxadustat – a novel oral treatment for anemia in Phase 3 • Targeting the multi-billion dollar global anemia market • IP protection expected through 2033 and potentially beyond • >1400 subjects evaluate
Slide 48: Discussion Materials
Discussion Materials May 2015