Everest Medicines Ltd. · HKEX:1952
Everest Medicines — Investor Presentation (April 2023)
30 slides from Everest Medicines's investor presentation, April 2023
Slide 1: Corporate Presentation
Corporate Presentation April 2023
Slide 2: Disclaimer
DISCLAIMER This presentation has been prepared by Everest Medicines Limited (the “Company” and together with its subsidiaries, the “Group”) solely for information purposes and does not constitute a recommendation regarding the securities of the Group or an offer to sell or issue or the solicitation
Slide 3: Investment Highlights
INVESTMENT HIGHLIGHTS 4 near-term product launches with aggregate peak sales potential of RMB 10bn: • Xerava – approved • Taniborbactam – 2024 • Nefecon – 2023 2H • Etrasimod - 2024 Therapeutic area leadership in renal disease and infectious disease with large unmet needs in Asia Strong discovery ca
Slide 4: Our Path Forward – Key Strategic Priorities
OUR PATH FORWARD – KEY STRATEGIC PRIORITIES Renal Disease Infectious mRNA platform Disease • Bivalent EVER-COVID19-M1 EUA • Commercialize Nefecon successfully • Commercialize XeravaTM • Build discovery pipeline of successfully therapeutic cancer vaccines • Advance Ever-001(BTK inhibitor) into phase
Slide 5: Broad Pipeline with First-in-Class or Best-in-Class Potential
BROAD PIPELINE WITH FIRST-IN-CLASS OR BEST-IN-CLASS POTENTIAL – 7 BLA/NDA APPROVALS EXPECTED IN THE NEXT FIVE YEARS Everest Clinical Status NDA/BLA Molecule Commercial Right Global Clinical Status Partner Indication BLA/NDA approval (Modality) (In-licensing time) Pre-clinical Phase1 Phase2 Phase3 Ap
Slide 6: Seasoned Management Team
SEASONED MANAGEMENT TEAM WITH INDUSTRY-LEADING COMMERCIALIZATION, DEVELOPMENT, DISCOVERY AND OPERATIONS CAPABILITIES Rogers Luo, Chief Ian Woo, MBA Zhengying Zhu, PhD Executive Officer President and Chief Chief Medical Officer, Financial Officer Internal Medicine ▪ Ex-president and general ▪ 14 year
Slide 7: Building a Renal Pipeline for Primary Glomerular Diseases
EVEREST IS DEDICATED TO BUILDING A RENAL PIPELINE TO ADDRESS SIGNIFICANT UNMET MEDICAL NEEDS FOR THE MOST COMMON PRIMARY GLOMERULAR DISEASES Focal Segmental IgA Nephropathy Membranous Minimal Change Indication Glomerulosclerosis (IgAN) Nephropathy (MN) Disease (MCD) (FSGS) Prevalence in China 4-5M ~
Slide 8: IgAN – A Significant Unmet Medical Need
IGAN – A SIGNIFICANT UNMET MEDICAL NEED Renal survival by category of TA-proteinuria in IgAN1 Genetic predisposition is required but not sufficient; environmental, bacterial, dietary factors may play a role Up to 50% of IgAN patients with disease progression are at the risk of kidney failure in 10-2
Slide 9: Nefecon: Designed to Target the Presumed Origin of the Disease
NEFECON: DESIGNED TO TARGET THE PRESUMED ORIGIN OF THE DISEASE Unique Targeted Release Profile Principle of Drug Delivery Delayed release: • Peyer’s patches are responsible for the production of Nefecon is designed to dissolve when they encounter the pH galactose-deficient IgA1 antibodies (Gd-IAg1)
Slide 10: Nefecon Phase 3 Data: Delay in Kidney Function Loss
NEFECON PHASE 3 DATA: FIRST THERAPY TO DEMONSTRATE DELAY IN KIDNEY FUNCTION LOSS • 9 month of dosing with 16mg Nefecon in 364 patients resulted in 50% less loss of kidney function vs placebo at 24 months • Treatment benefit on eGFR was apparent across baseline UPCR subgroups. Impact on eGFR at 9 mon
Slide 11: Nefecon Phase 3 Data: 2-Year Slope Analysis
NEFECON PHASE 3 DATA: 2-YEAR SLOPE ANALYSIS SHOW eGFR IMPROVEMENT ✓ Supportive analyses of eGFR 2-year slope were statistically significant and clinically relevant. ✓ The improvement in total 2-year eGFR slope was estimated to be 1.8 to 3.0 ml/min/ 1.73m2 per year for Nefecon 16mg once daily compare
Slide 12: Nefecon Phase 3 Data: Sustained UPCR Reduction
NEFECON PHASE 3 DATA: SUSTAINED UPCR REDUCTION AFTER TREATMENT STOPPED FOR 15 MONTH ✓ The % reduction in UPCR for Nefecon 16mg versus placebo increased over time from 3 to 12 months, and thereafter returned to end of treatment (9 months) levels at the end of the follow-up period (15 months). ✓ Susta
Slide 13: Multiple Regulatory Approvals of Nefecon Expected in 2023-2024
MULTIPLE REGULATORY APPROVALS OF NEFECON EXPECTED IN 2023 - 2024 Breakthrough NDA approval in NDA acceptance in Therapy Designation mainland China and China granted in China Singapore Nov-2022 Dec-2020 2023 Everest Phase III trial FSI Priority review Sep-2020 NDA approval in granted in China Hong Ko
Slide 14: Market Opportunity Concentrated in Southeastern and Central China
MARKET OPPORTUNITY IS CONCENTRATED IN SOUTHEASTERN AND CENTRAL CHINA, TOP 700 HOSPITALS REPRESENT 60% MARKET POTENTIAL • NRDL listing expected to be 2025 1H • Est. number of kidney biopsies nationwide:346,196 • Est. new incidences of IgAN：102,190 Hospital distribution of 80% market opportunity Accum
Slide 15: Kidney Disease Internal Discovery and BD Efforts
KIDNEY DISEASE INTERNAL DISCOVERY AND BD ACTIVE EFFORTS ON PRECISION DISEASE-MODIFYING MECHANISMS IN KEY PATHOGENIC PATHWAY/CELL POPULATIONS Upstream Event Downstream Event Autoantibody production Complement-mediated killing Podocyte injury • B cell and complement pathway are promising therapeutic t
Slide 16: Our Antibiotic Portfolio for MDR Gram-Negative Infections
OUR ANTIBIOTIC PORTFOLIO OF BEST-IN-CLASS THERAPIES FOR MDR GRAM- INFECTIONS Eravacycline Taniborbactam EVER206 (SPR206) ▪ A novel, fully synthetic ▪ Taniborbactam, a novel beta- ▪ A novel polymyxin derivative fluorocycline for the treatment lactamase inhibitor in with significantly reduced renal Mo
Slide 17: Xerava Approved in China for Complicated Intra-Abdominal Infections
XERAVATM APPROVED IN CHINA FOR TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS Approval on March 16, 2023 Commercial launch in Q3 2023 17
Slide 18: Critical Unmet Medical Needs in MDR Gram-Negative Infections
CRITICAL UNMET MEDICAL NEEDS IN MDR GRAM-NEGATIVE INFECTIONS TREATMENT Dominant clinical Gram-negative pathogens (2022) ✓ There were an estimated 4.95m death associated with bacterial antimicrobial resistance (AMR) in 2019, including 1.27m deaths attributable to bacterial AMR1. By 2050, deaths attri
Slide 19: Xerava Potent Activity in In-Vitro Susceptibility Studies
XERAVATM (ERAVACYCLINE) HAS SHOWN POTENT ANTIBACTERIAL ACTIVITY AGAINST CLINICALLY IMPORTANT ANTIBIOTIC- RESISTANT PATHOGENS IN IN-VITRO SUSCEPTIBILITY STUDIES CONDUCTED IN CHINA MIC90 distribution of eravacycline, tigecycline and imipenem against antibiotic-resistant gram-negative pathogens1 Xerava
Slide 20: Global Pivotal Study Results of Xerava in cIAI
GLOBAL PIVOTAL STUDY RESULTS OF XERAVATM SHOWN AS EFFECTIVE AS CARBAPENEMS IN cIAI Efficacy demonstrated as a monotherapy in two global pivotal studies1-4 ✓ Proven as effective as Carbapenems in cIAI with non-inferiority demonstrated in 2 pivotal clinical trials, non-inferior to ertapenem (IGNITE1)
Slide 21: Large Market Potential of Antibiotics for MDR Gram-Negative Infections in China
LARGE MARKET POTENTIAL OF ANTIBIOTICS FOR MDR GRAM-NEGATIVE INFECTIONS IN CHINA ✓ Tigecycline (a tetracycline) achieved sales of RMB ~2 billion in 2022 and volume of about 4.5m doses. XERAVATM (eravacycline) is a novel, fully synthetic, broad- spectrum, fluorocycline, parenteral antibiotic of the te
Slide 22: High Prevalence of CRAB in China and Xerava Commercial Launch Plan
HIGH PREVALENCE OF CRAB IN CHINA AND OUR COMMERCIAL LAUNCH PLAN OF XERAVATM IN CHINA Carbapenem-resistant Acinetobacter (CRAB) Prevalence in China, Efficient in-house commercial team with 100-120 FTEs to 2021 launch XeravaTM in core markets in Q3 of 2023 Heilongjiang Covering 300-500 hospitals with
Slide 23: Xerava International Commercial Plan
XERAVATM INTERNATIONAL COMMERCIAL PLAN • Already launched in Singapore with in-house team South Korea Singapore • 80% replacement of Tigecycline market in listed hospital • Approval expected in 2H 2023 Taiwan • Commercialization partnership with TTY Mainland China Biopharma Hong Kong Taiwan • NDA ap
Slide 24: Access to a Leading mRNA Platform
EVEREST HAS ACCESS TO A LEADING MRNA PLATFORM – COVERING THE ENTIRE INDUSTRIAL CHAIN FROM ANTIGEN DESIGN TO COMMERCIAL PRODUCTION Antigen Design LNP System Production Process mRNA Sequence Design System Continuous Development of the LNP Seasoned Multi-Disciplinary Vaccine • Completed the technology
Slide 25: mRNA Platform Pipeline and Manufacturing Plant at Jiashan
mRNA PLATFORM PIPELINE AND MANUFACTURING PLANT AT JIASHAN, A CITY NEAR SHANGHAI Program Indication Pre-clinical Phase I Phase II Phase III Everest Rights Remarks 2nd generation COVID-19 IND filing rolling submission EVER-COVID19-M1 booster started Rabies vaccine Rabies 50% Global Achieved proof-of-c
Slide 26: Phase 2 Data of 1st Gen COVID19 Vaccine PTX-COVID19-B
STELLAR PHASE 2 DATA OF 1ST GEN COVID19 VACCINE – PTX-COVID19-B VALIDATES OUR mRNA PLATFROM • The overall incidence of all-cause solicited adverse events (AEs) was similar between both treatment groups after the first and second doses: 71.6% and 59.0% for PTX-COVID19-B and 74.2% and 62.4% for Comirn
Slide 27: Etrasimod: Potential Best-in-Class Therapy for UC
ETRASIMOD: POTENTIAL BEST-IN-CLASS THERAPY FOR UC AND OTHER AUTOIMMUNE DISEASES Etrasimod Target Sphingosine-1-phosphate (S1P) receptor Positioning Best-in-class1 Indication Ulcerative Colitis (UC) Crohn’s Disease (CD) Atopic Dermatitis (AD) Prevalence of Ulcerative Colitis in China Prevalence of Cr
Slide 28: Etrasimod Demonstrated Differentiated Efficacy in UC
ETRASIMOD DEMONSTRATED DIFFERENTIATED EFFICACY IN UC ✓ Efficacy May Compare Favorably Across Contemporary UC Trials ✓ Safety profile in phase 3 was consistent with previous studies and the S1P class = Injectable = Oral Clinical Remission1,2 40% S1Ps Biologics JAKS P=0.026 p<0.001 p<0.001 p<0.05 p<0.
Slide 29: Top Tier Business Development Team and Global Partners
TOP TIER BUSINESS DEVELOPMENT TEAM AND TRUSTED GLOBAL PARTNERS ACROSS MULTIPLE THERAPEUTIC AREAS Proven Track Record in Asset Selection Our Partners Asset Acquiree/Licenser Acquirer/Licensee Deal Size Europe Etrasimod $6.7 bn $40 mn equity SPR206 $80mn milestones Asia Trodelvy $21 bn North $43 mn up
Slide 30: 2023 Catalysts
2023 CATALYSTS Molecule Milestone Status NDA approval in IgAN in China and Singapore Nefecon NDA filing in IgAN in Hong Kong, Taiwan and South Korea File for full approval with US FDA, EC and UK MHRA in 2023 EVER001 Phase 2 topline data readout NDA approval in cIAI in China XeravaTM NDA approval in
Everest Medicines — Investor Presentation (April 2023) on 6ix