Biomerica, Inc. · NASDAQ:BMRA
Biomerica — Investor Presentation (May 2024)
30 slides from Biomerica's investor presentation, May 2024
Slide 1: Investor Presentation May 2024
Investor Presentation May 2024 Copyright © 2024 Biomerica. All Rights Reserved
Slide 2: Forward-Looking Statement
Forward-Looking Statement The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain information included in this presentation (as well as information included in oral statements or other written statements made or to be made by Biomerica) c
Slide 3: Who We Are
Who We Are Depth of Scientific Leadership Global Biomedical Company US Members of the Rome Develops, patents, Our customers Foundation Clinical studies lead manufactures & markets in USA by principal investigators who advanced diagnostics for set GI “treatment guidelines” use in Clinical lab, Point-
Slide 4: Leadership, Board & Depth in Science
Leadership, Board & Depth in Science Management Scientific Advisory Board InFoods® Principal Investigators Principal ZACK IRANI Investigators or • Chief Executive Officer & Chairman Collaborators for: • Previous CEO & Chairman of Lancer DOUGLAS DROSSMAN, MD WILLIAM CHEY, MD, AGAF, Orthodontics Inc.
Slide 5: Background & Innovation
Background & Innovation Leveraging diagnostic expertise to transition into diagnostic-guided therapeutics Specialty diagnostics enabling early Disruptive patented technology disease detection and monitoring platform enabling diagnostic therapies Two FDA, CE, CFDA registered manufacturing Redefining
Slide 6: InFoods – Diagnostic Guided Therapy (DGT)
InFoods® – Diagnostic Guided Therapy (DGT) Personalize Medicine for IBS patients Example of Patient-Specific Results Food Result Blueberry + POSITIVE Chicken NEGATIVE Cabbage NEGATIVE FDA-regulated diagnostic to be used as therapy Egg + POSITIVE Garlic NEGATIVE Measures immunoreactivity for a panel
Slide 7: Irritable Bowel Syndrome (IBS) is Very Common
Irritable Bowel Syndrome (IBS) IBS is the #1 most common diagnosis made by IBS is the #7 most common diagnosis made by is Very Common gastroenterologists1 all physicians1 and Costly IBS sufferers have 74% IBS patients visit doctors 3x more direct healthcare more than non-IBS patients costs vs. non-I
Slide 8: IBS Market is Significant Today and Growing
M IBS Market is Significant Today and Growing D C 40 Million IBS Patients in the US $30B+ 1/3 IBS-C (Constipation) 1/3 IBS-D (Diarrhea) 1/3 IBS-M (Mixed: Alternates C+D) U.S. TAM1 IBS = recurrent abdominal pain & change in bowel habits ~16 M I L L I O N US IBS Patients: seeking consistent physician
Slide 9: Clinical Study
Clinical Study Copyright © 2024 Biomerica. All Rights Reserved 9
Slide 10: InFoods IBS: Clinical Trial Design Summary
InFoods® IBS: Clinical Trial Design Summary Randomized Double Blinded Placebo controlled Food consumption survey Patient is InFoods positive to: Blueberries & Almonds Treatment Arm Placebo Arm 1:1 Eliminates Eliminates Blueberries & Almonds Raspberries & Walnuts (if negative and same consumption) Co
Slide 11: Highlights InFoods IBS Top Line - Global Endpoints
Highlights InFoods® IBS Statistically meaningful improvements were seen in multiple endpoints (symptoms), this Top Line - Global Endpoints is only a selection of topline results from the InFoods® IBS endpoint trial Treatment Arm Vs. Placebo Arm Global Endpoints SGA P-value of 0.007 for improvement i
Slide 12: Highlights InFoods IBS Top Line - Pain and Bloating
Highlights InFoods® IBS Statistically meaningful improvements were seen in multiple endpoints (symptoms), this Top Line - Global Endpoints is only a selection of topline results from the InFoods® IBS endpoint trial Treatment Arm Vs. Placebo Arm Pain and Bloating API P-value of 0.012 for improvement
Slide 13: FDA Approved Drugs are Expensive and have Efficacy and Safety Limitations
FDA Approved Drugs are Expensive and have Efficacy and Safety Limitations FDA Treatment Placebo Treatment Monthly Annualized Indication Drug Limitations Approval Response Response minus Placebo Cost U.S. Sale • Diarrhea side Linzess 2012 20% - 34% 6% - 27% 7% - 14% $467 $1,963M effect (20%) IBS-C •
Slide 14: Copyright © 2024 Biomerica. All Rights Reserved
Copyright © 2024 Biomerica. All Rights Reserved 14
Slide 15: InFoods Regulatory & Commercial Pathway
InFoods® Regulatory & Commercial Pathway CLIA Lab Developed Test IP & Data Product Dev. R&D FDA Sub Q End Point Trial Dual Path Pivotal Trial FDA Approval 12 – 14 months CLIA Lab Developed Test to be FDA has determined proposed IBS Recently competed Endpoint Trial launched on fiscal Q3 clinical stud
Slide 16: Launch of InFoods IBS as LDT with Gastro Health
Launch of InFoods IBS as LDT with Gastro Health New Relationship with Gastro Health (GH): A leading gastroenterology group with over 390 employed GI physicians. A leader in advanced innovation and technology in GI patient care . Operates over 100 patient care centers in Alabama, Florida, Maryland, M
Slide 17: InFoods IBS: Whole Blood
InFoods IBS: Whole Blood inFoods® IBS: Now Validated for Use with Simple Finger Stick Whole Blood Collection Technology Finger stick (capillary) patient whole blood samples simplify sample collection and facilitate wider access to the test. Any trained medical professional in the doctor’s office can
Slide 18: InFoods IBS: Broad Benefits to Patients, Physicians, and Healthcare Insurers
InFoods® IBS: Broad Benefits to Patients, Physicians, and Healthcare Insurers Targets 100% of the IBS Market (IBS-M, IBS-C, IBS-D)1 Patient Benefits Physician Benefits Payer/insurer Benefits InFoods® targets underlying InFoods®: Recurring revenue InFoods® insurer savings causes without causing poten
Slide 19: InFoods Commercialization Strategy
InFoods® Commercialization Strategy Multiple Avenues to Drive Adoption Reimbursement Awareness Inclusion in Guidelines Broad Physician Interest and Enhanced Coverage Inclusion in the IBS treatment Help GI physicians monetize Capitalize on strong physician guidelines will accelerate their largest pat
Slide 20: SAB: Rome Foundation- Sets IBS Guidelines
SAB: Rome Foundation- Sets IBS Guidelines Expertise in Clinical Trials Rome Foundation Dr. Doug Drossman Key Expertise on (Leading IBS organization) (Biomerica SAB Chair) IBS Clinical Trials Leading independent non- Dr. Doug Drossman SAB members were the profit organization focused (President Emerit
Slide 21: Platform Technology: InFoods Development Pipeline
Platform InFoods® Technology: Development Pipeline Product End CLIA LDT Pivotal Trial & IP & Data FDA Sub Q Dev. R&D Point Trial Launch FDA Approval 20 Foods Irritable Bowel Syndrome (IBS) Functional Gastrointestinal 37 Foods Functional Dyspepsia Disorders 19 Foods GERD disease Gastrointestinal 58 F
Slide 22: Specialty Diagnostics
Specialty Diagnostics Copyright © 2024 Biomerica. All Rights Reserved 22
Slide 23: 2024 Growth opportunity - H. pylori
2024 Growth opportunity - H. pylori Status: Biomerica received FDA 510K clearance Detects H. pylori Antigen Gastric Cancer: Gastric cancer is the 3rd most common cause of cancer related death in the world. Over 80% of gastric cancers are attributed to H. pylori infection. In 2017, the World Health O
Slide 24: Colorectal Disease Test: EZ Detect
Colorectal Disease Test: EZ Detect EZ Detect is a 2-minute, at-home test for Quick & Simple: the determination of fecal occult blood, an early warning sign of colorectal cancer (CRC) and other colorectal diseases. No Stool Handling 1 2 3 Interpretation Negative Positive Positive Any color in the tes
Slide 25: Key performance metrics for EZ Detect, Cologuard, & FITs
Key performance metrics for EZ Detect , TM Cologuard®, & FITs Value EZ Detect (1) Cologuard® (2) FIT (2) Price $14 $649 $22 Accuracy 93.2% 86.6% 94.7% Positive Likelihood Ratio 91.2 6.9 14.3 Negative Likelihood Ratio 0.27 0.09 0.28 Specificity (vs. all negative findings 99.2% 86.6% 94.9% on colonosc
Slide 26: Copyright © 2022 Biomerica. All Rights Reserved
Copyright © 2022 Biomerica. All Rights Reserved 26
Slide 27: Aware Breast Self Exam
Aware® Breast Self Exam FDA – Cleared and CE Mark The Aware® Pad is as an aid for performing at- home breast self-examination About 80% of breast cancers are detected because women themselves notice changes in their breasts1 Recurrent purchases and several pads for female family members 1. https://w
Slide 28: Aware Performance
Aware® Performance Detection Ratios Clinical Study Fibroma Mastitis Kawasaki Medical University Hospital Breast Biopsy Case / Biopsy Case / Non-Tumor for Aware FDA approval (N=832 Patients) Cancer Non-Biopsy Case Non-Biopsy Case Patient 98.6% 90.9%/87.8% 86.4%/65.2% 9.8% Study concluded that Aware®
Slide 29: OTC Retail & Insurance reimbursement
& OTC Retail Insurance reimbursement New multi-year exclusive distribution agreement with leading UAE healthcare company recently signed Dubai Government Grants Insurance Reimbursement; In discussions with other governments for Insurance Reimbursement in UAE and other MENA countries In discussions f
Slide 30: Leveraging Our Unique Technology
Disruptive Patented Platform Technology redefining the GI Market Addressing the large need for IBS patients and then targeting multiple other diseases InFoods Model is Unique Leveraging Benefits Patient / Physician / Insurer Our Unique Broad IP Protection Robust patent portfolio (25 issued patents;