Biomerica, Inc. · NASDAQ:BMRA
Biomerica — Investor Presentation (February 2023)
29 slides from Biomerica's investor presentation, February 2023
Slide 1: Investor Presentation Feb 2023
Investor Presentation Feb 2023 Copyright © 2022 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: Diagnostic Guided Therapy
Diagnostic Guided Therapy Using Science, Diet and Technology to Revolutionize the GI Market Copyright © 2022 Biomerica. All Rights Reserved 3
Slide 4: Investment Highlights
Disruptive Patented Platform Technology redefining the GI Market First ever FDA-regulated diagnostic therapy Large Growing Market • $30+ Billion expansive market opportunity • Robust patent portfolio (11 issued patents; 100+ patents pending) Investment Significant Milestones Driving Growth • InFoods
Slide 5: 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 6: Background & Innovation
Background & Innovation Leveraging diagnostic expertise to transition into diagnostic-guided therapeutics Specialty diagnostics enabling early Disruptive patented technology platform disease detection and monitoring enabling diagnostic therapies Two FDA, CE, CFDA registered manufacturing Redefining
Slide 7: 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 8: 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% more IBS patients visit doctors 3x direct healthcare costs vs. more than non-IBS patients non-I
Slide 9: IBS Market is Significant Today and Growing
IBS Market is M Significant Today and Growing D C 40 Million IBS Patients in the US $30B+ U.S. TAM1 1/3 IBS-C 1/3 IBS-D 1/3 IBS-M (Mixed: (Constipation) (Diarrhea) Alternates C+D) ~16 M I L L I O N US IBS Patients: seeking consistent physician treatment ~13 M I L L I O N IBS-M Patients: No approved
Slide 10: 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 side
Slide 11: 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 12: InFoods IBS: Clinical Trial Design Summary
InFoods® IBS: Clinical Trial Design Summary Randomized Double Blinded Placebo controlled Patient is InFoods positive to: Blueberries & Almonds Treatment Arm Placebo Arm Eliminates Eliminates Raspberries & Walnuts Blueberries & Almonds (if negative and same consumption) Copyright © 2022 Biomerica. Al
Slide 13: Highlights InFoods IBS Top Line - Global Endpoints
Highlights InFoods® IBS Statistically meaningful improvements were seen in multiple endpoints Top Line - Global Endpoints (symptoms), this 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 14: Highlights InFoods IBS Top Line - Pain and Bloating
Highlights InFoods® IBS Statistically meaningful improvements were seen in multiple endpoints Top Line - Global Endpoints (symptoms), this is only a selection of topline results from the InFoods® IBS endpoint trial Treatment Arm Vs. Placebo Arm Pain and Bloating P-value of 0.012 for improvement in t
Slide 15: Copyright © 2022 Biomerica. All Rights Reserved
Copyright © 2022 Biomerica. All Rights Reserved 15
Slide 16: 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 17: Launch of InFoods IBS as LDT
Launch of InFoods IBS as LDT Patient pamphlet Physician data sheet Clinical Trial data Copyright © 2022 Biomerica. All Rights Reserved 17
Slide 18: 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 their Capitalize on strong physician guidelines will accelerate product lar
Slide 19: 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 PI’s profit organization focused (President E
Slide 20: Platform Technology: InFoods Development Pipeline
Platform InFoods® Technology: Development Pipeline Product End Pivotal FDA IP & Data FDA Sub Q Dev. R&D Point Trial Trial Approval Irritable Bowel Syndrome (IBS) Functional Gastrointestinal Functional Dyspepsia Disorders GERD disease Gastrointestinal Ulcerative Colitis (UC) Diseases Crohn’s Other Ch
Slide 21: Specialty Diagnostics
Specialty Diagnostics Copyright © 2022 Biomerica. All Rights Reserved 21
Slide 22: 2022 Growth opportunity - H. pylori
2022 Growth opportunity - H. pylori Status: Biomerica has submitted a 510k to FDA 510K submission. Approval expected soon. 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. pylo
Slide 23: 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 te
Slide 24: 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 colonos
Slide 25: Copyright © 2022 Biomerica. All Rights Reserved
Copyright © 2022 Biomerica. All Rights Reserved 25
Slide 26: 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://ww
Slide 27: 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 28: Available at Walmart
& Available at Walmart EZ Detect now in over Aware now in over 4,600 2,400 Walmart Stores Walmart Stores Available at Copyright © 2022 Biomerica. All Rights Reserved 28
Slide 29: 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 Broad IP Protection Our Unique Robust patent portfolio (11 issued patents;