Kyntra Bio, Inc. · NASDAQ:KYNB
Kyntra Bio — Fibrogen — Investor Presentation (January 2020)
49 slides from Kyntra Bio's investor presentation, Jan 13, 2020
Slide 1: FibroGen, Inc. Corporate Presentation January 2020
FibroGen, Inc. Corporate Presentation January 2020 Exhibit 99.1
Slide 2: Forward-looking statements
This presentation contains “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, business strategy, and plans, and objectiv
Slide 3: Company Overview
Company Overview 500+ employees worldwide 300+ U.S. 200+ ex-U.S. San Francisco headquarters with subsidiary in Beijing Enrique Conterno appointed CEO January 2020 Company Mission - developing innovative, first-in-class medicines for the treatment of chronic and life-threatening or debilitating condi
Slide 4: Enrique Conterno − CEO
Enrique Conterno − CEO Former Senior Vice President for Eli Lilly and Company, serving as President, Lilly USA, President, Lilly Diabetes, and a member of Lilly’s corporate executive committee. Nearly three decades of experience in the global healthcare industry include multiple strategic leadership
Slide 5: Strategy: First-in-class product programs addressing significant unmet need
Strategy: FIRST-IN-CLASS PRODUCT PROGRAMS ADDRESSING SIGNIFICANT UNMET MEDICAL AND PATIENT NEED ROXADUSTAT Anemia Associated with CKD Approved in China for NDD-CKD and DD-CKD Approved in Japan for DD-CKD NDD sNDA submission planned for early 2020 U.S. NDA submitted 4Q 2019 EU MAA submission anticipa
Slide 6: Roxadustat – oral HIF-PHI, 2019 Nobel Prize winning science
Roxadustat – oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) 2019 Nobel Prize winning science is the foundation of roxadustat Increases hemoglobin (Hb) by mimicking the body’s natural response to low oxygen Studied for treatment of anemia in Stage 3 to 5 CKD patients, both on an
Slide 7: Pamrevlumab: Innovative Treatment for Fibrosis and Fibroproliferative Disease
Pamrevlumab: Innovative Treatment for Fibrosis and Fibroproliferative Disease PAMREVLUMAB -- fully humanized monoclonal antibody targeting activity of connective tissue growth factor, a central factor in fibrosis and in various proliferative diseases
Slide 8: FibroGen Marketed and Late Stage Portfolio
FibroGen Marketed and Late Stage Portfolio with Blockbuster Portfolio Roxadustat – HIF-PHI PRECLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVED CKD Anemia United States, Europe China Japan1 MDS Anemia United States, Europe China (Phase 2/3) Chemotherapy-Induced Anemia United States, Europe Pamrevlumab – ANT
Slide 9: Roxadustat Anemia
Roxadustat Anemia
Slide 10: Roxadustat: An Innovative Approach to Addressing Anemia
Roxadustat: An Innovative Approach to Addressing Anemia ROXADUSTAT HAS BEEN SHOWN TO BE MORE THAN AN ORAL ALTERNATIVE TO ESAs Superiority to ESAs has been shown in hemoglobin change from baseline and reduction in risk of blood cell transfusion CV safety demonstrated in pooled analyses Overcomes supp
Slide 11: Potential Global Multi-Billion Dollar Markets for Anemia
Disease Dialysis Non-Dialysis Roxadustat Market Opportunity Clinician Nephrologist Where ESA Is Avail Now Endocrinologist/ Diabetologist/PCP Cardiologist/ Internist/PCP Myelodysplasia Chemotherapy Induced Anemia Oncologist IBD, Lupus, RA, etc. GI/Rheumatologist/ Internist Potential Global Multi-Bill
Slide 12: Chronic Kidney Disease is a Serious Health Burden Worldwide
850 million people worldwide have CKD1 CKD is the 6th fastest growing cause of death2 CKD causes 2.4 million deaths each year2 Chronic Kidney Disease (CKD) is a Serious Health Burden Worldwide Sources: 1. World Kidney Day website. https://www.worldkidneyday.org/world-kidney-day-is-only-20-days-away-
Slide 13: Anemia often untreated in CKD patients not on dialysis
Despite associated health risks, anemia is often left untreated in CKD patients not on dialysis (NDD) CKD Anemia Patients Not On Dialysis are Undertreated 37 million adults in the U.S. have CKD1 Only 13.6% of US patients were on ESA prior to initiating dialysis3 4.8 million U.S. CKD patients have an
Slide 14: Opportunity for therapies that overcome limitations of current SoC
Opportunity for therapies that can overcome the limitations of current SoC While Dialysis-Dependent Patients Typically Receive Anemia Therapy, Unmet Need Persists with Current SoC 1United States Renal Data System (USRDS) Annual Data Report 2019 estimate as of Year End 2017 DD-CKD population continue
Slide 15: Roxadustat Opportunity in Treatment of CKD Anemia
Roxadustat Opportunity in Treatment of CKD Anemia Source: 1. Nephrologist survey conducted by Company. EPO: erythropoietin Roxadustat, the potential first in class, orally administered small molecule HIF-PH inhibitor, has the potential to revolutionize the treatment paradigm in CKD anemia Past Only
Slide 16: Roxadustat NDD and DD Program: One of the Largest CKD Anemia Programs
EPO, epoetin alfa; Hb, hemoglobin; PEY, patient exposure year; R, Randomization; Roxa, roxadustat Roxadustat NDD and DD Program: One of the Largest CKD Anemia Clinical Development Programs Number of patients: 4277 Patient exposure years: 6194 Number of patients: 3880 Patient exposure years: 7059 Pha
Slide 17: NDD Roxadustat Program: Broad Range of Patients
NDD Roxadustat Program: Evaluation of Anemia Therapy In A Broad Range of Patients Not Included In Prior CKD Anemia Trials *Historical study patients' baseline Hb & eGFR characteristics in figure is based on approximations from published manuscripts eGFR, estimated glomerular filtration rate 0 10 203
Slide 18: NDD: Roxadustat is Superior to Placebo
NDD: Roxadustat is Superior to Placebo, Regardless of iron-repletion *Iron Replete: TSAT ≥20% and ferritin ≥100 ng/mL Individual Study: ANDES ALPS OLYMPUS LS mean (95% CI) 1.85 (1.74, 1.97); P<0.0001 1.69 (1.52, 1.86); P<0.001 1.35 (1.27, 1.43); P<0.001 -0.25 0 0.25 0.5 0.75 1 1.25 1.5 1.75 ∆Hb (g/d
Slide 19: DD: Larger Hb Increase Than EPO
Individual Studies ROCKIES HIMALAYAS SIERRAS LS mean difference (95% CI) 0.090 (0.010, 0.180) P=0.036 0.180 (0.079, 0.287) P<0.001 0.480 (0.365, 0.591) P<0.001 -0.50 0.00 0.50 1.00 Hb (g/dL) Group/n Roxadustat Active control 11.4 11.2 11 10.8 10.6 10.4 10.2 10 9.8 9.6 9.4 0 2 4 6 8 10 12 14 16 18 20
Slide 20: DD: Efficacious Regardless of Inflammation, Less IV Iron
DD: Roxadustat Efficacious Regardless of Inflammation, Requires Less IV iron than Epoetin Alfa Roxadustat achieved higher Hb increase in patients with inflammation (CRP > ULN) and in patients without inflammation (CRP ≤ ULN), compared to epoetin alfa Less IV iron was required in roxadustat patients
Slide 21: SIERRAS US-Only Study in Stable Dialysis Patients
SIERRAS (064) US-Only Study in Stable Dialysis Patients: Roxadustat Efficacy Unaffected by Inflammation & Durable Over Time Roxadustat patients with or without inflammation achieved comparable Hb levels with comparable average doses, and stable over 52 weeks. EPO patients with inflammation (CRP>ULN)
Slide 22: Roxadustat Lowers Use of Rescue Therapies and RBC Transfusion
Roxadustat Lowers Use of Rescue* Therapies in NDD; Reduction in RBC Transfusion in NDD (vs Placebo) and in DD (vs Epoetin Alfa) *Rescue = RBC transfusion, ESA, or IV iron 35% 30% 25% 20% 15% 10% 5% 0% RoxadustatPlacebo HR (95% CI) = 0.19 (0.16, 0.23) NDD: Rescue Use NDD: % patients with rescue use i
Slide 23: Roxadustat: Potential Additional Benefits in NDD
Roxadustat: Potential Additional Benefits in NDD LDL, low-density lipoprotein Change in eGFR from Baseline Patients with baseline eGFR ≥15 mL/min/1.73 m2 (N=2438) Mean LDL (mg/dL) over time up to Week 52 1373 1065 1311 1017 1269 979 1236 936 1189 863 1150 819 1086 760 1038 706 990 657 Group/n Roxadu
Slide 24: Cardiovascular Safety Endpoint Pooled Analyses
CV, cardiovascular Cardiovascular Safety Endpoint Pooled Analyses Cardiovascular (CV) safety endpoints analyzed in NDD pool and in DD pool Key safety endpoints: Time to first MACE MACE (Major Adverse Cardiovascular Events) include: all-cause mortality, myocardial infarction, and stroke Time to first
Slide 25: NDD: Pooled Cardiovascular Safety Endpoints
*“comparable” based on hazard ratio (HR) upper bound of 95% confidence interval (95%CI) below reference non-inferiority margin of 1.3 Risks of MACE, MACE+, or all-cause mortality in roxadustat patients were comparable to placebo in NDD patients* MACE MACE+ All Cause Mortality HR (95% CI) 1.08 (0.94,
Slide 26: DD: Pooled Cardiovascular Safety Endpoints
DD: Pooled Cardiovascular Safety Endpoints *“risk not increased” based on hazard ratio (HR) upper bound of 95% confidence interval (95%CI) below reference non-inferiority margin of 1.3. Risk of MACE and all-cause mortality in roxadustat patients were not increased compared to epoetin alfa in DD pati
Slide 27: Roxadustat Efficacy
Roxadustat efficacy was demonstrated Achieved primary efficacy endpoint (change in Hb) in individual studies and pooled analyses NDD: roxadustat was superior to placebo and efficacious regardless of iron-repletion DD: roxadustat achieved larger mean Hb increase than epoetin alfa, including in patien
Slide 28: Roxadustat CV Safety
Roxadustat CV Safety CV safety was demonstrated in all study populations Non-dialysis: Risk of MACE, MACE+, and all-cause mortality in roxadustat patients were comparable to placebo in NDD patients Incident dialysis: Roxadustat had 30% lower risk of MACE and 34% lower risk of MACE+ than epoetin alfa
Slide 29: Oncology Anemia Market Opportunity
Oncology Anemia Market Opportunity ADDRESSING UNDERSERVED PATIENT POPULATIONS 2National Cancer Institute estimates of annual diagnoses from 2007 to 2011. 3Anemia defined as Hb<12g/dL. Myelodysplastic Syndromes (MDS) 60K-170K US Prevalence Annual incident rate: 4.9/100K adults in U.S.2; 1.51/100K adu
Slide 30: Roxadustat Collaboration Economics
Roxadustat Collaboration Economics $ Millions Japan, EU, etc. U.S., China, ROW Payments Rec’d through Sep 30, 2019 Equity Investment in FibroGen $81 $20 $101 Upfront, Non-Contingent $360 $402 $762 Development and Reg. Milestones $543 $571 $170 Commercial Milestones $15 $653 $0 POTENTIAL TOTAL $918M
Slide 31: FibroGen China
FibroGen China
Slide 32: China: Roxadustat Commercialization Underway
FibroGen is Innovator and Marketing Authorization Holder (MAH) Roxadustat is sold under the FibroGen name China: Roxadustat Commercialization Underway FibroGen AstraZeneca 50/50 profit share AstraZeneca China is largest multinational pharma in China, with annual revenue exceeding $4 billion 15,000 s
Slide 33: China: Positive Momentum and Upwards Trajectory
China: Positive Momentum and Upwards Trajectory NDA Approval Dialysis (DD) approved Dec 2018 Non-Dialysis (NDD) approved Aug 2019 Pricing ~$2,000 patient price per year ~$1,500 ex-factory per year 95.5 RMB per 50mg capsule Reimbursement Admitted into National Reimbursement Drug List Dec 2019 Covers
Slide 34: China: Potential Markets - Differentiated Solution
~120 million people in China are living with CKD China: Potential Markets - Differentiated Solution Anemia Treatment Rate - 90% Treatment Rate with ESA - 90% Convert Installed Base – Substitute ESA Win Incident Patients – Direct to HIF-PHI instead of ESA LARGEST DIALYSIS MARKET IN THE WORLD NON-DIAL
Slide 35: Pamrevlumab
Pamrevlumab
Slide 36: Pamrevlumab: Innovative Treatment for Fibrosis and Fibroproliferative Disease
Pamrevlumab: Innovative Treatment for Fibrosis and Fibroproliferative Disease PAMREVLUMAB -- fully humanized monoclonal antibody targeting activity of connective tissue growth factor, a central factor in fibrosis and in various proliferative diseases
Slide 37: Pamrevlumab: Targeting 3 High Need Medical Indications
Idiopathic Pulmonary Fibrosis (IPF) FDA Fast Track and Orphan Drug Designation Randomized placebo-controlled, double-blind Phase 3 study enrolling Primary endpoint of change in forced vital capacity (FVC) from baseline Pancreatic Cancer (LAPC) FDA Fast Track and Orphan Drug Designation Randomized pl
Slide 38: IPF Patients Need New Therapeutic Options
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 ~$2B 2018 sales
Slide 39: Met Primary Efficacy Endpoint by Slowing Decline in FVC
Consistent with Results from Phase 2 Open-Label Study (Study 049) Met Primary Efficacy Endpoint by Slowing Decline in FVC Percent Predicted p-value = 0.0331
Slide 40: Pamrevlumab Attenuated Fibrosis Progression
Pamrevlumab Attenuated Fibrosis Progression Absolute differences in QLF changes from baseline to Weeks 24 and 48 between pamrevlumab arm and placebo were 61.6 ml and 76.2 ml, respectively First reported statistically significant results for attenuation of fibrosis by qHRCT Change in fibrosis (lung s
Slide 41: Reduced IPF Disease Progression
Reduced IPF Disease Progression Visit (Weeks) 12w 24w 36w 48w P-value* 0.1235 0.0527 0.0172 0.0103 Pamrevlumab, n (%) 3 (6.0%) 3 (6.0%) 5 (10.0%) 5 (10.0%) Placebo, n (%) 7 (13.7%) 9 (17.6%) 15 (29.4%) 16 (31.4%) Difference (%) -11.6% - 21.4% Relative Difference -56% -66% -66% -68% Relative Differen
Slide 42: ZEPHYRUS Pamrevlumab IPF Phase 3 Study
Patient Population IPF patients who are not currently 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 ~565 patients Randomization 3:2 pamrevlumab or placebo Primary End
Slide 43: LAPC Patient Population Lacks Treatment Options
LAPC Patient Population Lacks Treatment Options 1 2018 Estimates: http://seer.cancer.gov/statfacts/html/pancreas.html ADDRESSING UNDERSERVED, GROWING, AND EMERGENT PATIENT POPULATIONS 55K new U.S. patients Dx annually1 Clinical significance of resection ~27,700 (50%) present with no detectable metas
Slide 44: Statistically Significant Improvement in Median Survival
Statistically Significant Improvement in Median Survival p-value=0.0141 Statistically significant improvement of median survival in those who undergo resection Median survival for patients with non-resected tumors was 18.6 months Median survival for patients with resected tumors was >40 months Overa
Slide 45: LAPIS Pamrevlumab LAPC Phase 3 Study
Patient Population Locally advanced, unresectable pancreatic cancer ECOG 0-1 (health status of patient) No prior therapy Study Design Double-blind, placebo-controlled Enroll ~260 subjects at 40-60 sites globally Randomization 1:1 pamrevlumab + gemcitabine/nab-paclitaxel or placebo + gemcitabine/nab-
Slide 46: DMD Background
Affects ~1 in every 5,000 newborn boys About 20,000 children are diagnosed with DMD globally each year A fatal disease caused by genetic mutations leading to the absence or defect of dystrophin, a protein necessary for normal muscle function The absence of dystrophin results in muscle weakness, musc
Slide 47: Pamrevlumab DMD Program
Design Open-label, single-arm study in 21 non-ambulatory boys, 12 years of age and older Endpoints Change from baseline in: Pulmonary function tests Upper body muscle function tests Muscle and cardiac fibrosis by MRI imaging One-Year Administrative Analysis Results show potential to mitigate decline
Slide 48: Upcoming 2020 Milestones
ROXADUSTAT MAA submission to EMA for the treatment of anemia in dialysis-dependent and non-dialysis-dependent CKD patients anticipated 1H 2020 Japan NDD sNDA submission early 2020 China roxadustat launch ongoing Publication of Phase 3 roxadustat Data Potential roxadustat US approval PAMREVLUMAB Idio
Slide 49: Thank you
Thank you For more information contact at IR@fibrogen.com