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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

Key Takeaway: Corporate Presentation February 2016 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 th

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Corporate Presentation February 2016
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
accompanying modules, and in each case the oral commentary, including statements regarding our future financial condition, business strategy and plans and objectives of management for future operations, are forward looking statements. In some cases,
you can identify forward-looking statements by terminology such as "believe," "will," "may," "estimate," "continue," "anticipate," "contemplate,"
"intend," "target," "project," "should," "plan," "expect," "predict," "could," "potentially" or the negative of these terms or other similar
expressions. Forward looking statements appear in a number of places throughout this presentation, the accompanying modules, and in each case the accompanying oral commentary and include statements regarding our intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the timing of and our ability to initiate or enroll clinical trials, and our ability to make regulatory
filings and obtain and maintain regulatory approvals for roxadustat, FG-3019 and our other product candidates, our intellectual property position, the potential safety, efficacy, reimbursement, convenience clinical and pharmaco-economic benefits of
our product candidates, commercial opportunities, including potential market sizes and segments, the potential markets for any of our product candidates, our ability to develop commercial functions, our ability to operate in China, expectations
regarding clinical trial data, including all of the foregoing as it pertains to our collaboration partners AstraZeneca, AB and Astellas Pharma Inc., including cost-sharing, our results of operations, cash needs, financial condition, liquidity,
prospects, growth and strategies, the industry in which we operate and the trends that may affect the industry or us. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual
results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our management's beliefs and
assumptions only as of the date of this presentation, the accompanying modules, and in each case the oral commentary. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons
why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Forward-Looking Statements
IPF: idiopathic pulmonary fibrosis DMD:
Duchenne Muscular Dystrophy TREAT-NMD is an EU-based network aiming to advance treatments and care for patients with neuromuscular disease; TACT, the TREAT-NMD Advisory Committee for Therapeutics, is an expert multidisciplinary body that provides
the neuromuscular community with guidance on advancing new therapies for neuromuscular diseases Investment Highlights 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 evaluated in Ph1 + Ph2; Ph3 to enroll ~ 7500 to 8500 subjects globally Global collaborations: Astellas and AstraZeneca $2.5 billion in potential payments (~$818 million
received through 9/30/15) Plus royalties, transfer prices, and clinical development support Regulatory filings anticipated 2016 (China), 2018 (US) Funded through expected global commercialization FG-3019 - a novel anti-CTGF Ab for treating
fibrotic disease Phase 2 in idiopathic pulmonary fibrosis Phase 2 in pancreatic cancer Phase 2 in DMD non-ambulatory FG-5200 - collagen type III replacement cornea & scaffold for corneal blindness
HIF PLATFORM PRECLINICAL PHASE 1 PHASE
2 PHASE 3 Roxadustat (HIF-PH Inhibitor for anemia) United States / Europe China Japan Our Platforms and Product Portfolio FIBROTIC DISEASE PLATFORM PRECLINICAL PHASE 1 PHASE 2 PHASE 3 FG-3019 (Anti-CTGF Antibody) Idiopathic Pulmonary Fibrosis
Pancreatic Cancer Duchenne Muscular Dystrophy rhCOLLAGEN III SCAFFOLD PILOT PIVOTAL FG-5200 (Corneal Blindness)1 5-year POC study in 10 patients completed; filed as device in China. Wholly-Owned Partnered
Roxadustat - Recent Highlights
Global program on schedule to submit regulatory filings in 2016 for China and 2018 for US January 2016: DSMB chair reviewed safety data and recommended that studies continue with current protocols Target patient enrollment update (FibroGen
responsible for 3 of 7 Phase 3 studies) Stretch goal late 2015 - one study Base goal March/April 2016 - two studies Phase 2 completed in Japan Development expansion beyond CKD anemia in China
China Program - Recent Highlights Phase
3 clinical trials initiated First patient dosed DD-CKD Q4 2015 (N=300) First patient dosed ND-CKD Q4 2015 (N=150) Initial China regulatory submission expected in 2016 - rolling review Development expansion beyond CKD anemia AZ alignment on
China CTA submission plan Myelodysplastic syndromes (MDS) - 1H 2016 Chemotherapy-induced anemia (CIA)
FG-3019 - Recent Highlights IPF -
Study 067 FG-3019 vs. placebo arms >50% enrolled (target n=90) Expansion of study sites to include countries where approved IPF therapies have not fully penetrated the markets Expanding study to include patients on approved therapy Pancreatic
cancer - Study 069 Presentation of preliminary data at ASCO-GI Jan 2016 Trial expansion decision to be based on data from up to 42 subjects Duchenne Muscular Disease Phase 2 study of FG-3019 in DMD patients - first patient dosed Jan 2016
Liver Fibrosis in NASH Pre-IND meeting with FDA in Oct 2015 Assessing trial design and timing
Q3 2015 Financial Highlights $365.6M of
cash, cash equivalents, investments, and receivables on September 30, 2015 Cap of $116.5M on FibroGen's funding obligations for roxadustat CKD anemia development (ex-China) met in Q4 2015 Going forward, now that the cap has been met: Astellas
and AstraZeneca will be responsible for funding all roxadustat development in CKD Through launch for all territories ex-China Impact on FibroGen - reduction in operating expenses and increase in partner billings to 100% of development costs
Largely eliminates roxadustat cash burn ex-China Estimated cash balances: $330M to $340M - year-end 2015 $295M to $300M - year-end 2016 - projected
$116.5M Cap, 50-50 Roxadustat
Development Cost Share Met In Q4 2015 Before/After Illustration - Assuming $160M total annual roxadustat development expenses (based on Q2/Q3 2015 run rates) GAAP OpEx BEFORE: AstraZeneca bills FibroGen for $40M, or 50% of its $80M in
development expenses AFTER: AstraZeneca pays for all $80M of their own development expenses; FibroGen operating expenses reduced by $40M Cash Burn BEFORE: FibroGen bills AstraZeneca for $40M, or 50% of its $80M in development expenses AFTER:
FibroGen bills AstraZeneca 100% of its development expenses, or $80M; FibroGen billings increase by $40M Net Outcome GAAP Impact - $40M reduction in FibroGen Op Ex Cash Impact - FibroGen no longer pays 50% of AstraZeneca expenses; AstraZeneca
pays 100% of FibroGen expenses; FibroGen cash burn reduced $80M per annum
2015 2016 2017 2018 2H 1H 2H 1H 2H
1H 2H China EU / Japan IPF Pancreatic DMD Liver Development Timeline ROXADUSTAT FG-3019 Stretch Goal for Complete Enrollment in FGEN Ph3 Studies December 2015 Base Goal for Complete Enrollment in FGEN Ph3 Studies March/April 2016 26-week Data
Readout from Ph3 Initiate Regulatory Submission (rolling) Initiate Ph3 Q4 2015 NDA Approval ASCO GI presentation of available data (pancreatic resection study Initiate Ph 2 Study in Q4 2015 (non ambulatory) Production of Collagen Materials in
Beijing Facility IND Filing NASH US / ROW Regulatory Filing Submission FG-5200 Complete Enrollment Ph 2 Study (vs placebo) EU Phase 3 Studies Ongoing Ph3 Safety Extension Complete Initiate Chronic Toxicology Study Top-Line Data Ph 2 Study (vs
Anemia 101 THE CONDITION Reduced
Oxygen-Carrying Capacity of Blood ANEMIA IN CKD Dialysis & Pre-Dialysis INCREASED MORTALITY RED BLOOD CELL CREATION (ERYTHROPOIESIS) Hepcidin - Reduces Availability of Iron for RBC Production
LOW OXYGEN (e.g., High Altitude) or
HIF- ROXADUSTAT HIF- HIF- HIF-PH1 Enzymes HIF-PH Enzymes NORMAL OXYGEN Degradation HIF- Roxadustat Stabilizes HIF- Gene Transcription HIF- Degrades Rapidly EPO Within or Near Physiological Range Red Blood
Cell Production Hepcidin Levels Iron Transport to the Bone Marrow and Hemoglobin (Hb) Synthesis Iron Absorption Roxadustat Activates a Natural Pathway to Increase Red Blood Cell Production HIF- 1HIF-PH - hypoxia-inducible factor prolyl
1 Cmax data for roxadustat estimated
for a subset of 243 patients who achieved Hb response and were dosed at expected therapeutic doses. 2 Milledge & Cotes (1985) J Appl Physiol 59:360. 3 Goldberg et al. (1993), Clin Biochem 26:183, Maeda et al. (1992) Int J Hematol 55:111. 4 Kato
et al. (1994) Ren Fail 16:645. 5 Based on Flaherty et al. (1990) Clin Pharmacol Ther 47:557. EPO Cmax (mIU/mL) Altitude2 Blood Loss3 Pulm Edema4 0.99 1.20 1.60 20 44 93 0.16 3.86 Dose Distribution by Percentile mg/kg/dose Min 25% 50% 75% Max Dose
Distribution by Percentile (DOPPS Q4, 2011) U/kg/dose TIW 25% 50% 75% 95% 197 Roxadustat Achieves Target Hb within or near Physiologic EPO Cmax Levels ROXADUSTAT1 (Target Hb 11 to 13 g/dL) PHYSIOLOGICAL ADAPTATION (U.S. ESA Label: Hb 10 to 11 g/dL)
Roxadustat Increased Hb
Aranesp Increased Hb but Reduced Mean Cell Volume (Depletes Iron) IV Iron Ineffective Roxadustat Increased Hb Aranesp or IV Iron Ineffective for Anemia of Inflammation ESAs Ineffective or Require High Doses in Presence of Inflammation in
Preclinical Model Abs Hb g/dL 19.6 Aranesp (ESA) 15.4 IV Iron 19.3 Roxadustat 16.3 Vehicle -1 0 1 2 3 4 5 Hb Change from Baseline (g/dL) 10.4 Vehicle 13.0 Roxadustat 9.8 Aranesp (ESA) 9.5 IV Iron -1 0 1 2 3 4 5 Hb Change from Baseline (g/dL) Abs Hb
g/dL Normal Animals Anemia of Inflammation Model of inflammation using rats challenged with PG-PS, ACD; Klaus, S, et al, Induction of Erythropoiesis and Iron Utilization by FG-4592, Poster Presentation, ASN 2005.
Roxadustat Reduces Hepcidin
Decreased Hepcidin Improves Iron Availability and Reduces ESA Resistance CKD-DD Patients Previously Treated with EPO and Randomized (Study 040a) (Conversion, ESA Hyporesponders) CKD-DD Newly Initiated Dialysis (Study 053) Mean ( SE) Hepcidin
(ng/mL) n=52 n=52 Baseline Week 7 Baseline Week 7 Roxadustat 2 mg/kg EPO Control p-value: change in hepcidin level at Week 7 from baseline in roxadustat vs EPO n=9 n=9 Mean ( SE) Hepcidin (ng/mL) Roxadustat
Hb Correction and Maintenance by
Roxadustat Appear 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 hepcidin level in those with higher baseline hepcidin values ROXADUSTAT DOSE IN LAST 2 WEEKS CHANGE IN HEMOGLOBIN CHANGE IN HEPCIDIN
Phase 2 Program Conducted Across
Different CKD Populations STUDY PATIENTS WEEKS DOSE LEVELS TIER WEIGHTS CONTROL KEY RESULTS Placebo-Controlled Pre-Dialysis 017 Dose Range Finding, NDD 116 4 4 No Placebo Reduction in Hepcidin Dose-dependent Increase in Hb 047 Pre-dialysis 91 8 2 3
Placebo Encouraging Safety Data Validation of Tier Weight-based Dosing ESA-Controlled Dialysis Conversion 048 Dialysis (Converted) 96 6 3 3 ESA Encouraging Safety Data Successful Conversion from ESA IV & SQ 040a Dialysis 60 6 3 No ESA Successful
Conversion, Includes ESA Hyporesponsive Patients Dose Dependent Decrease in Hepcidin Phase 2b Key Proof of Concept Studies 041 Pre-dialysis (Six Correction and Maintenance Dose Cohorts) 145 16 and 24 6 3 Both tier weight and fixed starting doses can
initiate Hb correction Maintained Hb with TIW, BIW, QW Decrease in Blood Pressure Observed (Subgroup) Reduced Total Cholesterol Levels 040b Dialysis* (Conversion) 101 19 5 3 ESA Maintenance Reduced Total Cholesterol Levels 053 Dialysis (Newly
Initiated) 60 12 1 3 Oral Iron IV Iron Oral Iron HD oral Iron PD * Many patients were ESA hyporesponsive. Higher doses of ESA are generally needed to treat such patients.
Study 017: Placebo-Controlled Proof
of Concept Study in Pre-Dialysis Anemic Pre-dialysis Patients not Receiving ESA Randomized to Placebo or Roxadustat, BIW or TIW 4-week Dose Ranging Study Evaluating 4 Weight-based Doses Responder = Hb rise 1 g/dL Mean ( SE) hbmax
(g/dL) MEDIAN TIME TO RESPONSE 24.5 Days 14 Days 21 Days 14 Days DESIGN % Hb Responders 100% 91% 80% 100% 40% 58% 13% 30% 60% Statistically significant, dose-dependent Hb increase for all 4 doses and for all assessments from Day 8 (p=0.025) to end
of treatment (Day 22 p=0.0001; Day 26-29 p<0.0001) 100% Response Rate at Highest Dose Hepcidin reduction in 1.5 mg/kg cohort (p=0.048) and in 2.0 mg/kg cohort (p=0.001) OBSERVATIONS 0.7 mg/kg 1.0 mg/kg 1.5 mg/kg 2.0 mg/kg
Study 047: Placebo-Controlled Study
in Pre-dialysis TREATMENT N Baseline Hb MAX Change in HB P-Value vs Placebo PATIENTS WITH HB INCREASE 1 G/DL P-Value vs Placebo High Dose 31 8.9 2.4 <0.0001 93.1% <0.0001 Low Dose 30 8.8 1.6 <0.0001 88.5% <0.0001 Placebo 30 9.0
0.4 25.9% OBSERVATIONS High Dose: 1.77 mg/kg (n=31) Low Dose: 1.37 mg/kg (n=30)* Placebo (n=30) Mean ( SE) Hb Change from BL (g/dL) * Hb increase > 1 g/dL and Hb >11.0 g/dL at end of treatment DESIGN Anemic Pre-dialysis Patients not
Receiving ESA Randomized to Placebo or Roxadustat TIW Two Tier Weight-based Doses 8 Weeks Dosing Statistically Significant, Dose-dependent Hb Increase for Both Cohorts 93.1% Hb response rate at highest dose *n at baseline
Studies 048 and 040a: ESA Comparator
Study in Stable Dialysis Patients when Switched from Epoetin (Conversion) OBSERVATIONS - Study 048 OBSERVATIONS - Study 040a (6 wks) Hemodialysis Patients with Hb Corrected on Stable Doses of ESA Randomized to Roxadustat TIW or
Continuation of EPO for 6 Weeks of Treatment DESIGN Studies 048 and 040 Mean ( SE) Hemoglobin (g/dL) Roxadustat Maintained Hb in All Cohorts Hb Response Rates* Low Dose (59.1%), Mid Dose (88.9%), High Dose (100%) EPO (50%), p=0.005 (Mid Dose),
p=0.0002 (High Dose) Successful in Wide Range of Patients, Includes EPO Hyporesponsive Patients Study Weeks Study Weeks 0 1 2 3 4 5 6 (n=22) Low-dose, 1.37 mg/kg (n=22) Medium-dose, 1.65 mg/kg (n=18) High-dose, 2.02 mg/kg (n=20) * % of Patients
Maintaining Hb Level No Lower than 0.5 g/dL below Baseline at Both Week 6 and Week 7 Low-dose, 1 mg/kg (n=9) Medium-dose, 1.5 mg/kg (n=10) High-dose, 2 mg/kg (n=9) Epoetin (n=9) For Study 048, approximately 50:50 split between SC and
Study 040b: ESA Comparator Study in
Stable Dialysis Patients when Switched from Epoetin (Conversion) Mean ( SE) Hemoglobin (g/dL) DESIGN - Stable Dialysis Conversion from ESA Hemodialysis Patients with Hb Corrected on Stable Doses of ESA Randomized to Roxadustat TIW
or Continuation of EPO 19-week Treatment Duration Mean Baseline EPO Doses: 168 U/kg/wk IV (Dosed TIW) Low and High EPO Users Roxadustat Maintains Hb Levels Without IV Iron Roxadustat Maintains Hb Levels with Lower Cmax EPO Levels than IV Epoetin
Study 041: Dose Finding in
Pre-dialysis Different Targets, Different Correction Rates, Single Maintenance Algorithm 92% Response Rate Correction Achieved and Maintained to Ends of Treatment, Regardless of Starting and Maintenance Dose Reduction in Serum Hepcidin at Week 9 vs
Baseline, p=0.0003 CKD Patients not on Dialysis Roxadustat Starting Doses TIW or BIW Tier Weight Dosing: 3 Sizes Dose Titration to Achieve Hb Dose Adjustment Every 4 Wks Maintenance Dosing Upon Achieving Hb 11 g/dL TIW, BIW or QW Dual Endpoint
Hb 1 and Achieved Hb 11 g/dL 16 or 24 Week Treatment DESIGN OBSERVATIONS Mean ( SD) Hemoglobin (g/dL) Source: Besarab et al. 2011, J Am Soc Nephrol 22:196A BIW-QW,
Study 053: Roxadustat Corrects
Anemia in Newly Initiated Dialysis Patients without IV Iron Besarab, et al., J Am Soc Nephrol 23:428A and 24:91A. * p<0.05 compared to IV iron and oral iron * * Weeks on Treatment DESIGN OBSERVATIONS Incident Dialysis (Newly Initiated Dialysis)
Patients with Low Hb Levels and not on ESAs All Received Roxadustat Comparison of Treatment Response Under Different Iron Supplementation Conditions HD (Hemodialysis) Randomized to No Iron IV Iron Oral Iron PD (Peritoneal) Received Oral Iron
Roxadustat Raised Hb as Efficiently with Oral Iron as with IV Iron Oral and IV Iron Arms Had Similar Hb Responses in PD and HD 1 g/dL Hb correction in >90% patients at Week 12 Mean ( SE) Hemoglobin (g/dL)
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 Produced 90% Response Rates and Maintained Stable Hb In Nondialysis and Dialysis: Substantial Reduction of Hepcidin Observed in All Cohorts In Incident Dialysis: No Increased Level of Roxadustat Dosing Required (Study 053) In Dialysis: Oral
Iron is Comparable to IV Iron in Achieving and Maintaining Hb Correction with Roxadustat in Patients on Dialysis
Last updated: Feb 11, 2016