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8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 7, 2015

FibroGen, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-36740

77-0357827

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

FibroGen, Inc.

409 Illinois Street

San Francisco, CA 94158

(Address of principal executive offices, including zip code)

(415) 978-1200

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01

Regulation FD Disclosure

Beginning May 7, 2015, FibroGen, Inc. (the Company) intends to conduct meetings with existing and prospective investors and analysts in which its corporate slide presentation will be presented. A copy of the presentation materials, including a slide setting forth certain cautionary statements intended to qualify the forward-looking statements therein, is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 7.01 is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in Item 7.01 of this report will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this report is not intended to, and does not, constitute a determination or admission by the Company that the information in this report is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.

Item 9.01

Financial Statements and Exhibits.

(d)

Exhibits


Exhibit No.		Description

99.1		FibroGen, Inc. Presentation Materials dated May 7, 2015

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


	FIBROGEN, INC.

Dated: May 7, 2015

	By:	/s/ Michael Lowenstein
		Michael Lowenstein
		VP, Legal Affairs

INDEX TO EXHIBITS


Exhibit No.		Description

99.1		FibroGen, Inc. Presentation Materials dated May 7, 2015

EX-99.1

Discussion Materials

May 2015

Exhibit 99.1

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 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., our results of operations, cash needs,

spending of the proceeds from this offering, 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.

IPF: idiopathic pulmonary fibrosis

DMD: Duchenne Muscular Dystrophy

TREAT-NMD

EU-based

network

aiming

advance

treatments

and

care

for

patients

with

neuromuscular

disease;

TACT,

the

TREAT-NMD

Advisory

Committee

for

Therapeutics,

expert

multidisciplinary

body

that

provides

the

neuromuscular

community

with

guidance

advancing

new

therapies

for

neuromuscular

diseases

•

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

evaluated

P2;

enroll

7500

8500

subjects

globally

•

Global collaborations: Astellas and AstraZeneca

•

$2.5 billion in potential payments ($683 million received through 3/31/15)

•

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

•

FG-5200 –

collagen type III replacement cornea & scaffold for corneal blindness

•

$295M

$300

cash,

cash

equivalents,

investments,

receivables

3/31/15

(unaudited)

Investment Highlights

•

Phase 2 proof of concept established in IPF and pancreatic cancer

•

DMD clinical trial design reviewed by expert body of TREAT-NMD and advisory board

•

Pre-IND activities for DMD underway

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

approval

trials

China

currently

expected

start

2015

•

Completion of three scheduled reviews by data safety monitoring

board; recommendation at each review that study continue with no

protocol changes

•

Completion of two carcinogenicity study reports

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

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

•

Pancreatic cancer –

Study 069

–

Enrollment underway; preliminary data in late 2015

•

Duchenne Muscular Disease

–

Supportive reviews by TREAT-NMD Advisory Committee for Therapeutics

(TACT) and DMD advisory board

–

Phase 2 study of FG-3019 in DMD patients planned to start in H2 2015

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 2015

–

After the cap is reached, Astellas and AstraZeneca will be responsible for

funding roxadustat development in CKD through launch for all territories

ex-China

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

VP, Regulatory Affairs

ELIAS KOUCHAKJI, MD

VP, Drug Safety

MICHAEL LOWENSTEIN, JD

VP, Legal Affairs

ANATOLE BESARAB, MD

Exec Director, Clinical Research

LYNDA SZCZECH, MD

Exec Director, Clinical Development

SETH PORTER, PHD

Exec Director & FG-3019 Project Leader

GREG MANN

Exec Director, IR

Predecessor entities.

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)

Our Platforms and Product Portfolio

FIBROTIC DISEASE PLATFORM

PRECLINICAL

PHASE 1

PHASE 2

PHASE 3

FG-3019

(Anti-CTGF

Antibody)

•

Pancreatic Cancer

•

IPF

•

Liver Fibrosis

•

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

2014

2015

2016

2017

US/

ROW

EU/

Japan

China

(incl.

Cornea)

IPF

Pancreatic

DMD

TACT Review

Development Timeline

ROXADUSTAT

FG-3019

Initiate

AZ Studies

NDD&DD

Initiate FGN

Stable DD Study

FDA Ph3

Statistical Analysis

Plan Review

(NDD&DD)

Publications Ph2

NDD & DD

Complete

Enrollment NDD

Study

US, Asia Pacific,

Latin America

Complete

Enrollment Global

Incident Dialysis

Study

Data Readout

Ph3 NDD

Data Cut for EU

Database Lock

Complete

Enrollment

FibroGen Stable

DD Study

Cornea

Green Pass

(Expedited Review)

Submission

CFDA

Certification

for GMP

Operations

Data Readout

Ph3

Roxadustat

Regulatory

Submission

Initiate Ph3

Roxadustat

NDA

Approval

Roxadustat

Start Phase 2

Study

DMD Advisory

Board Review

Publications

Ph2 NDD

& DD

Phase 3 Studies Ongoing

Initiate Final

EU Ph3 (DD)

Study

Publication

Ph2a Study

Complete

Enrollment

Ph2b Study

Data Readout

Ph2b Study

Interim Data

Stage 3 Study

Initiate

Stage 3 Ph2

Study

Initiate

Stage 4 Ph2 Study

Roxadustat

Anemia 101

THE

CONDITION

Reduced Oxygen-Carrying

Capacity of Blood

ANEMIA IN CKD

Dialysis & Pre-Dialysis

INCREASED

MORTALITY

RED BLOOD CELL CREATION

(ERYTHROPOIESIS)

Reduces Availability of

Iron for RBC Production

LOW

OXYGEN

(e.g. High Altitude)

HIF

ROXADUSTAT

HIF

HIF-PH

Enzymes

HIF-PH Enzymes

NORMAL

OXYGEN

Degradation

HIF

Roxadustat Stabilizes HIF

Gene Transcription

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

HIF-PH -

hypoxia-inducible factor prolyl hydroxylase

max

data for roxadustat estimated for a subset of 243 patients who achieved Hb response and were dosed at expected therapeutic doses.

Milledge & Cotes (1985) J Appl Physiol 59:360.

Goldberg et al. (1993), Clin Biochem 26:183, Maeda et al. (1992)

Int J Hematol 55:111.

Kato et al. (1994) Ren Fail 16:645.

Based on Flaherty et al. (1990) Clin Pharmacol Ther 47:557.

EPO C

max

(mIU/mL)

Altitude

Blood Loss

Pulm

Edema

0.99

1.20

1.60

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 with Physiologic

EPO C

max

Levels

ROXADUSTAT

(Target Hb 11 to 13 g/dL)

PHYSIOLOGICAL

ADAPTATION

(U.S. ESA Label:

Hb 10 to 11 g/dL)

ESA

1,000

2,000

3,000

4,000

5,000

6,000

•

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

10.4

Vehicle

13.0

Roxadustat

9.8

Aranesp

(ESA)

9.5

IV Iron

-1

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

Baseline

Week 7

Baseline

Week 7

p-value: change in hepcidin level at Week 7

from baseline in roxadustat vs EPO

n=9

Mean

(±SE)

Hepcidin

(ng/mL)

100

150

200

250

300

350

400

p=0.038

Roxadustat

2 mg/kg

EPO

Control

100

Baseline

Week 5

<0.0001

n=52

Roxadustat

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 hepcidin level in

those with higher baseline hepcidin

values

Phase 2 Program Conducted Across Different CKD

Populations

* Many patients were ESA hyporesponsive. Higher doses of ESA are

generally needed to treat such patients.

STUDY

PATIENTS

WEEKS

DOSE

LEVELS

TIER

WEIGHTS

CONTROL

KEY

RESULTS

Placebo-Controlled Pre-Dialysis

017

Dose

Range

Finding, NDD

116

Placebo

•

Reduction

in Hepcidin

•

Dose-dependent

Increase in Hb

047

Pre-dialysis

Placebo

•

Encouraging Safety Data

•

Validation of

Tier Weight-based Dosing

ESA-Controlled Dialysis Conversion

048

Dialysis

(Converted)

ESA

•

Encouraging Safety Data

•

Successful

Conversion from ESA IV & SQ

040a

Dialysis

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

and

•

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

ESA

•

Maintenance

•

Reduced Total Cholesterol Levels

053

Dialysis

(Newly Initiated)

•

Oral Iron

IV Iron

Oral Iron HD

oral Iron PD

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)

max

(g/dL)

MEDIAN TIME TO RESPONSE

24.5

Days

DESIGN

100

•

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

0.0

0.5

1.0

1.5

2.0

2.5

3.0

DESIGN

Hb Responders

Placebo

(N=23)

BIW

(N=10)

TIW

(N=12)

BIW

(N=5)

TIW

(N=5)

BIW

(N=10)

TIW

(N=11)

BIW

(N=9)

TIW

(N=11)

1.0 mg/kg

0.7 mg/kg

1.5 mg/kg

2.0 mg/kg

Study 047: Placebo-Controlled Study in

Pre-dialysis

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

Study Weeks

PATIENTS

WITH HB

INCREASE >

G/DL

P-VALUE VS

PLACEBO

P-VALUE

PLACEBO

MAX

CHANGE

IN HB

BASELINE

TREATMENT

High Dose

8.9

2.4

<0.0001

93.1%

<0.0001

Low Dose

8.8

1.6

<0.0001

88.5%

<0.0001

Placebo

9.0

0.4

25.9%

Studies 048 and 040a: ESA Comparator Study in Stable

Dialysis Patients when Switched from Epoetin

(Conversion)

OBSERVATIONS

–

Study

048

OBSERVATIONS

–

Study

040a

wks)

•

Hemodialysis Patients with Hb Corrected on Stable Doses of ESA

For Study 048, approximately 50:50 split between SC and IV

•

Randomized to Roxadustat TIW or Continuation of EPO for 6 Weeks of Treatment

DESIGN

Studies 048 and 040

•

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

* % 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 a

(n=9)

Study Weeks

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

OBSERVATIONS

Roxadustat (n=61)

Study 041: Dose Finding in Pre-dialysis

Different Targets, Different Correction Rates, Single Maintenance Algorithm

•

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

and

Achieved

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

10.5

11.0

11.5

12.0

12.5

13.0

Duration of Treatment (Weeks)

Cohort A (tiered, TIW

TIW, n=23)

Cohort B (tiered, TIW

BIW, n=24)

Cohort C (fixed, 50 mg, TIW

-TIW, n=23)

Cohort E (tiered, BIW-QW, n=24)

Cohort F (fixed, 70 mg, TIW-BIW

QW, n=25)

Target Hb

Cohorts A,B,E & F

Target Hb,

Cohorts C&D

10.0

9.5

•

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

Cohort D (fixed, 100 mg, TIW-TIW, n=24)

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

•

(Hemodialysis)

Randomized

–

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

Roxadustat Safety Review

•

No Overall Safety Signal

–

An independent data monitoring committee reviewed data

–

Frequency and type of AEs expected in CKD patients

•

No Cardiovascular Signal

•

Lowers

Cholesterol

Levels

•

No Increase in Blood Pressure

•

Reduction in Blood Pressure at End of TIW Dosing

•

Platelet Reduction in Patients with High Platelet Count

•

No Cardiac Conduction Effect (TQT Study Negative)

•

No Drug Related Renal Toxicity

•

No Liver Safety Signal, No Special Liver Monitoring Requirement in

Phase 3

SAFETY

OBSERVATIONS

IN COMPLETED

PHASE 1 & 2

STUDIES

Roxadustat Exposure

~1,100 Subjects

16 patients > 1 year

9 patients > 3 years

EXTENSIVE

PRECLINICAL

EVALUATION OF

CANCER RISK

•

Carcinogenicity Studies Complete

•

No Clinical Evidence of Tumor Risk to Date

Treatment-Emergent Serious Adverse Events

Protocol 017

4 Weeks

Protocol 047

8 Weeks

Roxadustat

Placebo

Roxadustat

Placebo

Number of subjects

SAEs

4 (4.5%)*

1 (3.6%)

8 (13.1%)*

4 (13.3%)

Cardiovascular SAEs

1 (3.6%)

1 (3.3%)

CSE**

1 (3.3%)

Protocol 048

6 Weeks

Protocol 040b

19 Weeks

Roxadustat

EPO

Roxadustat

EPO

Number of subjects

SAEs

15 (22.7%)*

4 (17.4%)

Cardiovascular SAEs

1 (1.5%)

2 (8.7%)

CSE**

8 (12.1%)

4 (17.4%)

EPO-Controlled Phase 2 Trials (Conversion study in dialysis patients)

Placebo-Controlled Phase 2 Trials (Anemia correction in non-dialysis patients)

*No SAEs were attributed to roxadustat in completed trials. No statistically significant differences from comparators.

**CSE=death, myocardial infarction, congestive heart failure, subendocardial ischaemia, cerebrovascular accident,

thrombosis (fistula), arteriovenous fistula occlusion, angina pectoris, and vascular graft thrombosis.

Roxadustat Submissions for Marketing Approvals:

US, Europe, and China

•

Indication

–

Treatment

Anemia

Associated

with

Chronic

Kidney

Disease

(CKD)

Patients

Dialysis

and

Not on Dialysis

•

Primary

Efficacy

Endpoints

Based

Hemoglobin

(Hb)

Measurements

–

Change in Hb from Baseline, or % Hb responders

–

EU:

pre-specify

primary

endpoint

region

–

Dialysis (DD) -

in addition to stable dialysis, include incident dialysis, a high-risk population

–

Nondialysis (NDD) –

first placebo-controlled pivotal study for this population

•

~ 8,000

Subjects

Studies*

ex-China,

China)

* Excludes Japan where Phase 2 studies are being completed and Phase 3 plans will be finalized in 2015.

** Plan to support US regulatory approval with 7 studies (4 DD and 3 NDD), 5 of which (3DD and 2 NDD) will also be used in the European

package that contains a total of 6 studies (3 DD and 3 NDD).

REGULATORY AUTHORITIES

EUROPE

CHINA

# of P3 Studies to Support Regulatory Approval

7**

6**

# of P3 Patients to Support Regulatory Approval

~7,500**

Up to 4,000**

450

Minimum Duration

52+ weeks

36+ weeks

26-52 weeks

(100 for 1 yr)

Average Duration

1.3 to 1.5 years

1 year

6-12 months

Estimated Patient Years

~10,000

~4,000

~275

Mandatory Post-Approval Safety Study (China)

None at this time

~2,000 patients

Pharma Partners

AstraZeneca

Astellas

AstraZeneca

•

Safety Assessment Focused on Cardiovascular Events, Large Phase 3 Program for CKD Anemia

Roxadustat Phase 3 Program

STUDY

NUMBER

COMPARATOR

RANDOM-

IZATION

STUDY

LOCATIONS

CHINA

EUROPE

STUDY

SPONSOR

PHASE 3 STUDIES TO SUPPORT REGULATORY APPROVAL

Stable Dialysis

CL-613

Epoetin

/Darbe

376/200/174

750

EU, MEA

36+ wks

52+wks

Astellas

FG-064

Epoetin

1:1

Up to 750

US+/-Global

36+ wks

52+wks

FibroGen

FG-806

Epoetin

2:1

300

China

26-52 wks

FibroGen

Incident Dialysis

FG-063

Epoetin

1:1

Up to 750

Global

36+wks

52+ wks

FibroGen

Incident and Stable Dialysis

AZ-002

Epoetin

1:1

1425

Global

52+ wks

AstraZeneca

Non-Dialysis

FG-060*

Placebo

2:1

Up to 600

US, LA

, APAC

36+ wks

52+ wks

FibroGen

CL-0608*

Placebo

2:1

450-600

EU, MEA

36+ wks

52+ wks

Astellas

FG-808

Placebo

2:1

150

China

26-52 wks

FibroGen

AZ-001

Placebo

1:1

~2,600

Global

52+ wks

AstraZeneca

EUROPEAN REIMBURSEMENT STUDY

CL-0610

Darbepoetin

2:1

570

EU, MEA

36+ wks

N/A

Astellas

Plan to support US regulatory approval with 7 studies (4 DD and 3 NDD), 5 of which (3DD and 2 NDD, highlighted) will

also be used in the European package that contains a total of 6 studies (3 DD and 3 NDD)

Latin

America;

APAC

Asia-Pacific;

MEA

Middle

East

Africa

Roxadustat Has Potential to Address Unmet Need

in Multiple Markets

FibroGen estimate

Disease

Dialysis

Pre

-Dialysis

Limitations

on ESA

Treatment

Clinician

Nephrologist Where

ESA

Is Avail Now

36% Anemic¹

20% Anemic¹

Endocrinologist/

Diabetologist

Cardiologist/

IBD, Lupus, RA,

etc.

GI/Rheumatologist/

Internist

JAPAN

CHINA, ASIA, ex-Japan

EU, CIS

FDA Safety

Issues

Not Referred to Nephrologists

‘Delayed Referral’

Safety Issues

(Higher ESA doses

required v CKD)

Transfusion Mkt

ESAs Not

Demonstrated

to Work

Generic

ESAs

Partnered with

Astellas

Costly

Treatment

Internist

CKD

DIABETES

HYPERTENSION

CANCER

INFLAMMATORY

Secondary CKD

Myelodysplasia

Chemotherapy

Induced Anemia

Oncologist

Potential Multiple Global, Multi-Billion Dollar

Markets for Anemia

DIABETES

HYPERTENSION

Secondary CKD

New Market:

First-in-Class Oral Therapy

in Secondary CKD

EU, CIS

JAPAN

Existing and

New Markets:

Cost Effective

Re-Establish

Market:

Safer Option

CANCER

New Market:

Treat in Presence

of Inflammation

INFLAMMATORY

FibroGen estimate

Mainly New Market:

Opportunity to Become

Standard of Care for

Serious Unmet Need

CHINA, ASIA, ex-Japan

Disease

Dialysis

Pre-Dialysis

Roxadustat

Market

Opportunity

Clinician

Nephrologist

Where

ESA Is Avail Now

36% Anemic

20% Anemic

Endocrinologist/

Diabetologist

Cardiologist/

Myelodysplasia

Chemotherapy

Oncologist

IBD, Lupus, RA,

etc.

GI/Rheumatologist/

Internist

Induced Anemia

CKD

Existing Market:

Superiority to ESAs

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

Phase 2

•

Completed End of Phase 2 meetings with regulators

–

Phase 3 MACE-based safety endpoints based on end of Phase 2

discussions with FDA

–

Planned US NDA submission for both dialysis and pre-dialysis

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

increase

1 g/dL

Renal SAEs and/or dialysis initiation

5.5% (8)

Dialysis initiation while on study

3.4%

(5=4

SAEs

non-SAE)

With no dialysis

2.1% (3)

SAEs –

probably or possibly related

Deaths –

probably or possibly related

SAEs –

related (angioedema, severe

allergic reaction)

SAEs –

related (liver abnormality)

Phase 3 Dosing Regimen

Optimized for Hb Effect and Convenience

Starting dose: non-dialysis (1 study)

Starting doses: non-dialysis and incident dialysis (3 studies and 1 study, resp.)

Starting dose: stable dialysis (3 studies)

Conversion from baseline EPO dose to roxadustat dose, based on conversion factor data from

two Phase 2 studies

3x per week (TIW) dose frequency

•

Except a subset of 2 non-dialysis studies

•

BIW 2x/ week n~ 60 in study FG-060, n=20+ in CL-608, also testing in CL-610

•

QW 1X/ week n~ 60 in study FG-060, n= 20+ in CL-608, also testing in CL-610

Dose adjustments every 4 weeks, tested in five Phase 2 studies

Experience from Phase 1 and Phase 2 supports Phase 3 dosing regimen

Phase 2

•

Several hundred patients dosed at doses being utilized in Phase 3

Phase 1:

•

> 300 subjects dosed between 0.4 to 3 mg/kg

•

Dose-limiting toxicity not reached at highest dose of 5 mg/kg

Body weight (kg)

<70 kg

70 kg

Roxadustat dose

70 mg

100 mg

Roxadustat dose

70 mg

China Opportunity

•

Unique Positioning as a Domestic

Chinese Company

•

CFDA Green Pass Status

•

AZ, Our Commercial Partner,

2nd Largest Multinational

Pharmaceutical Company by

Sales in China

•

1st Phase 3 Results with

Roxadustat –

Potential 1st Launch

Country

•

Potential Entry into #2 Pharma

Market in the World

•

Platform for Rapid Entry into

China

–

Corneal

Implants

•

Mean Hb 9.1 Achieved

with Use of ESA

•

300,000-400,000 Patients,

Reaching Size of US

Dialysis Population

•

20% to 30% Annual

Growth in Dialysis Capacity

Since 2007 and Expected

to Continue Near Term

•

Growth Driven by Severe

Disease Reimbursement

Policy and Demographics

NON-DIALYSIS

DIALYSIS

STAGE 4 PRE-DIALYSIS

Dialysis Eligible Population,

1-2 million

Progression

to End Stage

Renal

Disease

•

Very Sick, Highly

Anemic, Dialysis Stage

Population

•

Very Limited ESA Use

Graphic not to scale

Corneal Implants –

FG-5200 (China)

Proprietary Recombinant

Human Type III Collagen

•

Integration of Implants with Host Tissue

•

Encourages Nerve Regeneration

•

Allows for Clearer Vision and No Rejection

Central corneal scar

covering entire pupil

Most of pupil

is blocked

URGENT,

SEVERE UNMET

MEDICAL NEED

•

Approximately 4 to 5 Million Patients with Corneal Blindness in China

•

100,000 New Cases per Year, Approx. 3,000 Corneal Implant Surgeries

•

Cadaver Transplants Very Limited by Cultural Restriction

PLATFORM TO

FOCUS ON

CHINA FIRST

•

FG-5200 Targets Patients Treatable with Partial Thickness Implants

•

60-month Proof of Concept Data with Prototype in 10 Patients in Sweden

•

Possibility to Address Major Unmet Need –

Science Translational Medicine

•

Opportunity to Expand Outside China

•

Plan to Meet with CFDA on Clinical Program

Roxadustat Global Partnerships

$ Millions

JAPAN,

EU, ETC.

U.S., CHINA,

ROW

CASH RECEIVED

TO DATE

Equity Investment

in FibroGen

$81

$20

$101

Upfront,

Non-Contingent

$360

$402

$360 + $220

Development & Reg.

Milestones

$543

$571

$103+ $0

Commercial

Milestones

$15

$653

POTENTIAL TOTAL

$918 M

$1,626 M

$683 M of $2,543 M

Low 20% (Astellas) –

Low-Mid 20% (AstraZeneca)

Net Sales Royalty / Transfer Price

FibroGen ex-China Costs Capped at $116.5 M

(Cost-Share < 50% of Planned CKD Anemia Development Costs)

Commercialization Costs Are Covered by Partners

in All Territories Ex-China

PAYMENTS TO

FIBROGEN

China

Partnership:

50% Profit Sharing

and 50%

Development and

Launch Cost

Responsibility

DEVELOPMENT

FUNDING

LAUNCH

FUNDING

FG-3019

Monoclonal Antibody to Connective Tissue Growth Factor (CTGF)

FG-3019 Improved Fibrosis in Mouse Model

and in Human Disease

Reversal of Lung Fibrosis by

High Resolution CT at Week 48

Subject

NORMAL

WEEK 18

Two Weeks of FG-3019

WEEKS 16

Pre-Treatment

Week Post-Irradiation

Radiation-Induced Mouse Lung Fibrosis

Phase 2A IPF Clinical Trial

Reversal of Fibrosis by Micro-CT Imaging

Reversal of Fibrosis by Histology

Improved / Stable Fibrosis Correlates

with Improved Lung Function

Improved/

Stable Fibrosis

Worse

Fibrosis

Improved/Stable

Relationship of 1-Year Survival to Dose

Percent 1 Year

Survival Rate

•

Dose-Related Increase in Survival

•

Day-15

Minimum

FG-3019

Plasma

Level

150

µg/mL

Median Survival (9.4 vs. 4.8 Months) (p=0.025)

One-Year Survival (37% v 11%) (p=0.01)

Phase 2 Dose-Dependent Survival in

Advanced Pancreatic Cancer

Relationship of Survival to FG-3019

Day-15 Plasma Levels

Percent Overall Survival

Overall Survival Time (Months)

FG-3019 Combined with Gemcitabine and Erlotinib (n=75)

22.5

17.5

KEY

FINDINGS

Weekly

mg/kg

Biweekly

mg/kg

FG-3019 >

150 µg/mL; n=38

FG-3019 < 150 µg/mL; n=37

p=0.025

10%

30%

31%

25%

10%

15%

20%

25%

30%

35%

100

Phase 2 Trials in IPF and

Pancreatic Cancer

•

Main goal: convert to operable state

•

40 patients to be enrolled, with potential to expand

•

Randomization 1:1 up to 6 months of

•

Endpoint: complete tumor removal

•

Currently enrolling

LOCALLY

ADVANCED

INOPERABLE

PANCREATIC

CANCER

•

Combination of FG-3019 and Chemotherapy

•

~240 patients

•

Randomization 1:1 , treat to progression

•

Endpoints: CA19.9, tumor response (PET & CT scans), disease control

•

Study design under development

METASTATIC

PANCREATIC

CANCER NOT

PREVIOUSLY

TREATED

•

Randomized placebo-controlled clinical trial

•

136 patients

•

Naïve; previously treated; pirfenidone / nintedanib failures

•

Key endpoints

–

Pulmonary function: change in FVC from baseline

–

Fibrosis by HRCT

•

Currently enrolling

IPF

–

FG-3019, gemcitabine, nab-paclitaxel

–

Gemcitabine and nab-paclitaxel

–

FG-3019, gemcitabine, nab-paclitaxel

–

Gemcitabine and nab-paclitaxel

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 fibrotic tissue in advanced disease

•

CTGF:

Directly

impacts

not

just

fibrosis

but

muscle

cell

phenotype

–

Strongly associated with fibrosis in skeletal muscle of human muscular

dystrophy (MD)

–

Strongly associated with fibrosis in heart of mouse (mdx) MD

–

Induces de-differentiation of skeletal muscle cells

–

Over-expression in normal mice transiently induces features of skeletal MD

–

Reducing CTGF reduces mdx mouse MD

(2011);

Morales

(2011);

Morales

(2013);

Pessina

(2014);

Vial

(2008)

FG-3019 Decreased Fibrosis and Increased

Muscle Strength in mdx Mice

FG-3019 significantly reduced collagen

content/fibrosis in muscle (mdx mouse)

FG-3019 increased Isometric Force by 50%

(mdx mouse)

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

FG-3019 Increased Muscle Endurance in mdx Mice

5-min treadmill exercise tolerance test:

•

Morales, Hum Mol Genet-Suppl Data (2013)

mdx mice treated with FG-3019

stopped fewer times to rest than

untreated mice (mdx-control) and

were more similar to normal mice

Investment Highlights

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

•

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

evaluated

P2;

enroll

7500

8500

subjects

globally

•

Global collaborations: Astellas and AstraZeneca

•

$2.5 billion in potential payments ($683 million received through 3/31/15)

•

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

•

FG-5200 –

collagen type III replacement cornea & scaffold for corneal blindness

•

$295

$300

cash,

cash

equivalents,

investments,

receivables

3/31/15

(unaudited)

•

Phase 2 proof of concept established in IPF and pancreatic cancer

•

DMD clinical trial design reviewed by expert body of TREAT-NMD and advisory board

•

Pre-IND activities underway

May 2015

Discussion Materials