Full Press Release Details
FibroGen, Inc. Corporate Presentation
January 2019 Exhibit 99.1
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"forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition,
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include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, our ongoing and planned development and clinical trials, the timing of and our ability to make regulatory
filings and obtain and maintain regulatory approvals for roxadustat, pamrevlumab, and our other product candidates, the potential safety, efficacy, reimbursement, convenience, or clinical and pharmaco-economic benefits of our product candidates,
including in China, the potential markets for any of our product candidates, our ability to develop commercial functions, or our ability to operate in China, expectations regarding clinical trial data, our results of operations, cash needs, spending
of proceeds from our public offerings, 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
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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
2019: A Transformational Year >5
Anemia associated with CKD Approved in China for dialysis in 2018 NDA approval decisions expected in 2019: Japan for dialysis China for non-dialysis NDA submissions expected in 2019: U.S., EU, other territories Anemia Associated with MDS One U.S./EU
Phase 3, one China Phase 2/3 trial ongoing ROXADUSTAT TWO FIRST-IN-CLASS PRODUCT PLATFORMS ADDRESSING MAJOR MARKETS WITH SIGNIFICANT PATIENT NEED 1 PAMREVLUMAB IPF Phase 3 study starting in 2019 Pancreatic Cancer Phase 3 study starting in 2019 DMD
Phase 2 trial ongoing 1 2
Product Portfolio HIF-PHI PRECLINICAL
PHASE 1 PHASE 2 PHASE 3 APPROVED Roxadustat CKD Anemia United States, Europe China1 Japan2 Roxadustat MDS Anemia United States, Europe China (Phase 2/3) ANTI-CTGF PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Pamrevlumab Idiopathic Pulmonary Fibrosis
Pancreatic Cancer Duchenne Muscular Dystrophy Wholly Owned Partnered 1Dialysis-dependent NDA approved; non-dialysis dependent NDA filed in China 2Dialysis-dependent NDA filed in Japan; non-dialysis dependent trials are ongoing
Corporate and Financial 465 employees
worldwide 310 U.S. 155 ex-U.S. San Francisco headquarters with subsidiary in Beijing Appointed Maykin Ho, Ph.D., to Board of Directors in December 2018 Well-managed financial position No debt Year-end cash balance projection of $720M to $730M $722M
cash as of September 30, 2018; no debt
Roxadustat: An Innovative Approach to
Addressing Anemia *First approved in China for anemia associated with CKD in dialysis-dependent patients on December 17, 2018. ROXADUSTAT HAS BEEN SHOWN TO BE MORE THAN AN ORAL ALTERNATIVE TO ESAs Overcomes suppressive effects of inflammation on
erythropoiesis Coordinate iron mobilization, hepcidin reduction Erythropoietin levels within or near physiological range Superiority to ESAs has been shown in hemoglobin change from baseline and reduction in risk of blood cell transfusion + >>
INTERNALLY ADVANCED BY FIBROGEN FROM DISCOVERY THROUGH LATE-STAGE CLINICAL DEVELOPMENT AND APPROVAL* Dialysis-dependent and non-dialysis-dependent CKD patients Anemia associated with MDS PARTNERED WITH ASTRAZENECA AND ASTELLAS Astellas: Europe,
Middle East, CIS, South Africa, Japan AstraZeneca: U.S./ROW; China
Roxadustat: The Leader in Oral HIF-PHI
Anemia Therapeutics Anemia in CKD Patients U.S./EU Positive Phase 3 results from five trials announced by FibroGen and AstraZeneca December 2018 Positive Phase 3 topline results announced by Astellas from first EU study All Phase 3 studies
supporting U.S. NDA and EU MAA completed MACE pooled analysis readouts (DD, NDD) anticipated in 1H 2019 U.S. NDA submission planned for 1H 2019 China NDA approved by the NMPA for dialysis-dependent patients in December 2018 NDA approval anticipated
for non-dialysis in 1H 2019 Launch planned for 2H 2019 Japan NDA for dialysis-dependent patients submitted to PMDA in September, 2018 Astellas completed 1 of 2 CKD non-dialysis dependent Phase 3 studies needed for sNDA Anemia Associated with MDS
U.S. Phase 3 and China Phase 2/3 studies underway
Roxadustat in China FIRST APPROVAL
China is the first country to approve a HIF-PHI FIRST TO MARKET Commercialization Activities FibroGen and AstraZeneca China working closely to prepare for 2H 2019 launch FibroGen China to lead: Medical Affairs Pharmacovigilance Regulatory Affairs
Commercial Manufacturing Post-Approval Clinical Development AstraZeneca China to lead: Marketing Market Access Sales Commercial Operations
U.S. and China CKD Anemia Market
Opportunity ADDRESSING UNDERSERVED, GROWING, AND EMERGENT PATIENT POPULATIONS 1United States Renal Data System (USRDS) estimate as of 2016 UNITED STATES CHINA >35M CKD patients Linked to diabetes and hypertension Hepcidin modulation may benefit
broader CKD anemia population > 500K Dialysis patients1 AZ leads marketing, sales, and distribution with strong presence in diabetes and hypertension markets >500K CKD dialysis patients Double-digit Y/Y growth rate Large DD population
significantly undertreated "Severe disease" reimbursement classification AZ leads marketing and sales with strong and established presence
CL-314 ESA naive, non-dialysis, open
label 100 CL-310 ESA conversion, non-dialysis, vs. darbepoetin ~325 Japan Non-Dialysis Total N ~425 Global Registration Programs: Enrollment Summary GLOBAL PHASE 3 STUDIES FOR U.S. NDA, EU MAA DD-CKD Studies N Population, Comparator HIMALAYAS
(FibroGen) 063 1,043 Incident dialysis, vs. epoetin SIERRAS (FibroGen) 064 741 Stable/Incident dalysis, vs. epoetin ROCKIES (AstraZeneca) 002 2,133 Stable/Incident dialysis, vs. epoetin PYRENEES (Astellas) CL-613 838 Stable
dialysis, vs. epoetin or darbepoetin Dialysis Total N 4,755 NDD-CKD studies N Population, Comparator ANDES (FibroGen) 060 922 Non-dialysis, vs. placebo OLYMPUS (AstraZeneca) 001 2,782 Non-dialysis, vs. placebo ALPS (Astellas) CL-608 597
Non-dialysis, vs. placebo Non-Dialysis Total 4,301 DOLOMITES (Astellas) CL-610 616 Non-dialysis, vs. darbepoetin, for EU reimbursement JPN Studies Population, Comparator N CL-307 ESA conversion, hemodialysis, vs. darbepoetin 303 CL-312 ESA
conversion long-term, hemodialysis, open label 164 CL-308 ESA na ve, hemodialysis, open label 75 CL-302 Peritoneal dialysis, open label 56 Japan Dialysis Total N 598 Completed China Phase 3 Studies Support China NDA Approval Completed Japan
Phase 3 Dialysis Studies, NDA (DD) Submitted Sept'18 China Studies Population, Comparator N 806 Dialysis, vs. epoetin 304 808 Non-dialysis, vs. placebo 151 China Phase 3 Total N 455 Japan Phase 3 CKD-NDD Studies for sNDA (NDD) Studies
ANDES Roxadustat Phase 3 CKD-NDD
Study(060) Randomized, double-blind, placebo-controlled study in U.S., APAC, S. America Chronic kidney disease (Stages 3, 4, or 5) not on dialysis, no prior ESA use N=922; roxadustat (n=616) vs. placebo (n=306) Treatment Duration: up to 4.5 years,
mean=1.7 years U.S. Primary Endpoint Mean Hb change from baseline to the average over wks 28-52 (g/dL) EU Primary Efficacy Endpoint (U.S. Secondary Endpoint) % Hb Responders: 86.0% (roxadustat) vs. 6.6% (placebo), p=0.0007 Secondary Endpoints Time
to first use of a rescue therapy (blood transfusion, ESA, or IV iron) in the first 52 weeks: 81% reduction in risk of rescue use (HR=0.19), p<0.0001 Time to first blood transfusion during the first 52 weeks: 74% reduction in blood transfusion
risk (HR=0.26), p<0.0001 Safety: An overall safety profile consistent with the results observed in prior roxadustat studies. The adverse events reported are consistent with those expected in these study populations with similar background
diseases g/dL P=0.0001 Mean ( SE) Hemoglobin (g/dL) (FAS)
HIMALAYAS Roxadustat Phase 3
Incident Dialysis Study (063) Randomized, open-label, active-controlled global study (U.S., Asia Pacific, Europe, Russia, S. America) Anemic incident dialysis patients with baseline Hb <10 g/dL, minimal to no prior ESA use N=1043; roxadustat
(n=522) vs. epoetin alfa (n=521) Treatment Duration: up to 4.4 years, mean=1.8 years U.S. Primary Endpoint Mean Hb change from baseline to the average over Weeks 28-52 Non-inferior: LS-means (LSM) difference=0.18; lower bound of the 95% CI of (0.08,
0.29) 0.75 g/dL (NI margin); Superiority to epoetin alfa, p=0.0005 EU Primary Efficacy Endpoint (U.S. secondary endpoint) % Hb Responder: 88.2% (roxadustat) vs. 84.5% (epoetin alfa) Non-inferior: lower bound of the 95% CI (-0.9%, 7.6%) of
the treatment difference is >-15% (NI margin) Safety: An overall safety profile consistent with the results observed in prior roxadustat studies. The adverse events reported are consistent with those expected in these study populations with
similar background diseases Mean ( SE) Hemoglobin (g/dL) (FAS)
SIERRAS Roxadustat Phase 3
Conversion Study in Dialysis Patients (064) Randomized, open-label, active-controlled U.S. study N=741; roxadustat (n=370) vs. epoetin alfa (n=371) Stable dialysis patients with baseline Hb 9 - 12 g/dL, on stable doses of ESA Newly initiated
dialysis patients with baseline Hb 8.5 - 12 g/dL Treatment Duration: up to 3.5 years, mean=1.9 years U.S. Primary Endpoint Mean Hb change from baseline to the average over Weeks 28-52 Non-inferior to epoetin alfa: LSM difference = 0.48 g/dL Lower
bound of the 95% CI of (0.37, 0.59) 0.75 g/dL (NI margin) Superiority over epoetin alfa, p<0.0001 EU Primary Efficacy Endpoint (U.S. Secondary Endpoint) Mean Hb change from baseline to the average over Wks 28-36 Non-inferior LSM difference
= 0.53 g/dL Lower bound of the 95% CI of (0.39, 0.67) 0.75 g/dL (NI margin) Superiority over epoetin alfa, p<0.0001 Secondary Endpoint Time to first blood transfusion during the first 52 weeks: 33% reduction in blood transfusion
risk (HR=0.67), p=0.0337 p<0.0001 Hb Change (g/dL) Safety: An overall safety profile consistent with the results observed in prior roxadustat studies. The adverse events reported are consistent with those expected in these study populations with
similar background diseases Mean ( SE) Hemoglobin (g/dL) (FAS)
Olympus Phase 3 CKD-NDD Study
Double-blind, placebo-controlled study in 26 countries CKD patients, non-dialysis (Stages 3, 4 or 5) with baseline Hb <10 g/dL N=2,781; randomized 1:1, roxadustat or placebo Primary Efficacy Endpoint The trial met its primary efficacy endpoint by
demonstrating a statistically significant and clinically meaningful improvement in mean change from baseline in Hb levels averaged over Weeks 28 to 52 vs. placebo Rockies Phase 3 CKD-DD Study Open-label, active-controlled study in 18 countries ESRD
patients, dialysis-dependent N=2,133; randomized 1:1, roxadustat or epoetin alfa Primary Efficacy Endpoint The trial met its primary efficacy endpoint by demonstrating a statistically significant improvement in mean change from baseline in Hb levels
averaged over Weeks 28 to 52 vs. epoetin alfa Roxadustat Phase 3 Clinical Studies Topline Result (AstraZeneca Sponsored)
U.S. / EU Phase 3 MDS Study Patient
population: transfusion-dependent, ESA-na ve, lower risk MDS patients Open-label lead-in: N up to 24 Starting doses (8 each): 1.5 mg/kg, 2.0 mg/kg, 2.5 mg/kg Double-blind, placebo-controlled: N=160 3:2 randomization, roxadustat vs. placebo
Primary endpoint at 28 weeks: Cumulative % patients achieved transfusion independence (over at least 8 weeks) Safety exposure: up to 52 weeks Sites in U.S., EU, APAC Roxadustat Ongoing Pivotal MDS Anemia Studies China Phase 2/3 MDS Study Patient
population: non-transfusion dependent with baseline Hb of 6 to 10 g/dL, lower risk MDS patients Open-label: N up to 40 Double-blind, placebo-controlled: N=135 2:1 randomization, roxadustat vs. placebo Primary endpoints at 26 weeks: % patients with
Hb increased by 1.5 g/dL from baseline Treatment duration: 26 weeks ~30 sites in China
Idiopathic Pulmonary Fibrosis (IPF)
FDA Fast Track designation Phase 3 study planned to start in Q1 2019 Randomized placebo-controlled, double-blind study similar to PRAISE Phase 2b study design Primary endpoint will be change in forced vital capacity (FVC) from baseline Pancreatic
Cancer (LAPC) FDA Fast Track and Orphan Drug Designation Phase 3 study planned to start in Q1 2019 Randomized double-blind, placebo-controlled study evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel as neoadjuvant treatment
Assess resectability and resection rates with the primary endpoint of overall survival Duchenne Muscular Dystrophy (DMD) Phase 2 trial fully enrolled All patients will have completed first of three years on trial in Q1 2019 Initial data anticipated
at end of Q1 2019 Pamrevlumab: Three High-Value, High-Need Indications
Pamrevlumab: Potential Innovative
Treatment for Fibrosis and Fibroproliferative Diseases
Pamrevlumab Idiopathic Pulmonary
IPF Patients Need New Therapeutic
Options 1 Raghu 2006 and United Nations Population Division 2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3848422/ Slow pulmonary function loss Modest effect on slowing disease progression No demonstration of reversal Require side effect management
~$1.8B 2017 sales U.S. prevalence of ~44,000 to 135,0001 U.S. incidence of ~21,000 to 52,0001 cases per year Incident and mortality are on the rise, and prevalence is expected to increase with the aging population2 PROGRESSIVE Leads to irreversible
loss of lung function with high morbidity and mortality rates Median survival of 3-5 years following diagnosis ORPHAN DISEASE CURRENT TREATMENTS !
Patient Population IPF patients who
are not being treated with approved therapies IPF diagnosis according to ATS/ERS/JRS/ALAT guidelines* Study Design Placebo-controlled, double-blind Similar to PRAISE Phase 2b study Enroll ~500 patients Randomization 3:2 pamrevlumab or placebo
Primary Endpoint Change in forced vital capacity (FVC) from baseline Secondary Endpoints Composite clinical outcome of disease progression Patient reported outcomes Quantitative changes in lung fibrosis volume from baseline Others Pamrevlumab IPF
Phase 3 Study Design *Raghu, 2018
PRAISE Phase 2 double-blind,
placebo-controlled study (n=103) Met primary endpoint of change in FVC % predicted from baseline to Week 48 Average decline in FVC by Week 48 was significantly less in pamrevlumab arm Significantly smaller proportion of patients in the pamrevlumab
arm experienced disease progression (FVC % predicted decline 10% or death) Statistically significant attenuation of fibrosis change by qHRCT vs. placebo at Weeks 24 and 48 Strong trends for improvement in health-related quality of life
(HRQoL) relative to placebo Pamrevlumab IPF Program: Positive Phase 2 Results
Pamrevlumab Pancreatic
LAPC Patient Population Lacks
Treatment Options 1 2018 Estimates: http://seer.cancer.gov/statfacts/html/pancreas.html ADDRESSING UNDERSERVED, GROWING, AND EMERGENT PATIENT POPULATIONS new U.S. patients Dx annually1 Clinical significance of resection 55K ~27,700 (50%) present