Biomerica, Inc. · NASDAQ:BMRA
Biomerica — Investor Presentation (April 2023)
29 slides from Biomerica's investor presentation, Apr 25, 2023
Slide 1: Investor Presentation April 2023
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 BIOMERICA ©)inFoods
Slide 4: Investment Highlights
Investment Highlights Disruptive Patented Platform Technology redefining the GI Market Personalized treatment for IBS patients Large Growing Market + $30+ Billion expansive market opportunity + Robust patent portfolio (11 issued patents; 100+ patents pending) Significant Milestones Driving Growth +
Slide 5: Leadership, Board & Depth in Science
Leadership, Board & Depth in Science Management ZACK IRANI + Chief Executive Officer & Chairman + Previous CEO & Chairman of Lancer Orthodontics Inc. ALLEN BARBIERI + Executive Vice Chairman and private companies ROBERT CARLSON + Chief Commercial Officer + Previous CCO of Prometheus Laboratories , a
Slide 6: Background & Innovation
BIOMERICA Background & Innovation Leveraging diagnostic expertise to transition into diagnostic-guided therapeutics © inFoods Disruptive patented technology platform enabling diagnostic therapies Specialty diagnostics enabling early disease detection and monitoring Two FDA, CE, CFDA registered manuf
Slide 7: InFoods - Diagnostic Guided Therapy (DGT)
InFoods® - Diagnostic Guided Therapy (DGT) Personalize Medicine for IBS patients Example of Patient-Specific Results Result Chicken NEGATIVE Z f Cabbage NEGATIVE S) FDA-regulated diagnostic to be used as therapy Egg -#POSITIVE Garlic NEGATIVE <5) Measures immunoreactivity for a panel of foods to det
Slide 8: Irritable Bowel Syndrome (IBS) is Very Common and Costly
Irritable Bowel Syndrome (IBS) is Very Common and Costly ‘Recent AGA Survey (American Gastroenterological Association), BIOMERICA IBS is the #1 most common diagnosis made by gastroenterologists' IBS patients visit doctors 3x more than non-IBS patients IBS is the #7 most common diagnosis made by all
Slide 9: IBS Market is Significant Today and Growing
IBS Market is Significa nt Today IBS Patients in the US and Growing $3 0 ie + 1/3 IBS-C 1/3 IBS-M (Mixed: Alternates C+D) (Constipation) U.S. TAM! Million ~1 6 US IBS Patients: ~1 3 IBS-M Patients: seeking consistent No approved MILLION _ physician treatment MILLION therapy/drug? ‘Global prevalence
Slide 10: InFoods IBS: Broad Benefits to Patients, Physicians, and Healthcare Insurers
InFoods® IBS: Broad Benefits to Patients, Physicians, and Healthcare Insurers Patient Benefits Physician Benefits Payer/insurer Benefits InFoods® targets underlying InFoods®: Recurring revenue InFoods® insurer savings causes without causing potential as problem foods Currently: IBS Patients require
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 Approval Response Response minus Placebo Cost U.S. Sale Indication Limitations + Diarrhea side Linzess 2012 20% - 34% 6% - 27% 7% - 14% $467 $1,963M effect (20%) + Indicated f
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 OinFoods Treatment Arm Placebo Arm Eliminates Eliminates Blueberries & Almonds Raspberries & Walnuts (if negative and same consumption) Copyright © 2023 Biom
Slide 13: Highlights InFoods IBS
Highlights InFoods® IBS Statistically meaningful improvements were Top Line - Global Endpoints seen in multiple endpoints (symptoms), this is only a selection of topline results from the InFoods® IBS endpoint trial OiinFoods Treatment Arm Vs. Placebo Arm Global Endpoints SGA 2 P-value of 0.007 for i
Slide 14: Highlights InFoods IBS: Pain and Bloating
1 2. Highlights Statistically meaningful improvements were seen in multiple endpoints (symptoms), this is only a selection of topline results from the InFoods® IBS endpoint trial Pain and Bloating API Bloating InFoods® IBS Top Line - Global Endpoints OinFoods Treatment Arm Vs. Placebo Arm P-value of
Slide 15: Abdominal Pain Index (API) Change from Baseline
Abdominal Pain Index (API) Change from Baseline IBS non-D Population 0) Increased Abdominal 0.2 Pain -0.4 zou gies ges mY Cc -0.8 cys ogo See a 1.2 Decreased Abdominal La Pain “~ 1.6 0 2 4 8 Weeks on Diet Linear Mixed Model —True Diet —Sham Diet Wk 8 P-Value 0.0139 BIOMERICA> Copyright © 2023 Biomer
Slide 16: InFoods Regulatory & Commercial Pathway
InFoods® Regulatory & Commercial Pathway CLIA Lab Developed Test Dual Path otal Trial 14 month: S) Recently competed Endpoint Trial results driving significant interest from physician groups FDA Approval FDA has determined proposed IBS 5S) CLIA Lab Developed Test to be clinical study is a non-signif
Slide 17: Launch of InFoods IBS as LDT with Gastro Health
Launch of InFoods IBS as LDT with Gastro Health @©)inFoods IBS ©iinFoods IBS New Relationship with Gastro Health (GH): You are ina cnc ee . , . Clinic, Harvard, University of A leading gastroenterology group with over 390 employed unique menigon, vest ofS GI physicians. A leader in advanced innovati
Slide 18: InFoods Commercialization Strategy
InFoods® Commercialization Strategy Multiple Avenues to Drive Adoption ) ) Inclusion in Guidelines Inclusion in the IBS treatment guidelines will accelerate product adoption The Rome Foundation holds significant influence in setting the treatment guidelines Reimbursement Awareness ~) ) and Enhanced
Slide 19: SAB: Rome Foundation - Sets IBS Guidelines
SAB: Rome Foundation- Sets IBS Guidelines Expertise in Clinical Trials Rome Foundation (Leading IBS organization) Leading independent non- profit organization focused on the diagnosis and treatment of functional gastrointestinal disorders, including IBS Rome creates the diagnostic criteria and guide
Slide 20: InFoods Platform Technology Development Pipeline
Platform Technology: Functional Gastrointestinal Disorders Gastrointestinal Diseases Other Chronic Inflammatory Diseases BIOMERICA> InFoods® Development Pipeline Ulcerative Colitis (UC) Dermatology Copyright © 2023 Biomerica. All Rights Reserved {20}
Slide 21: Specialty Diagnostics
Specialty ca a Diagnostics ULCER COLON BREAST = SCREENING \ wie DISEASE SELF TEST » TEST EXAM Foe de on A lal EARLY DETECTION IS In-home results in 2 minutes YOUR BEST PROTECTION
Slide 22: 2023 Growth opportunity - H. pylori
2023 Growth opportunity - H. pylori Detects H. pylori Antigen H. pylori is a bacteria that infects approximately 35% of the U.S. population and 45% of the population in the five major countries in the Europe. Approximately 20% of H. Pylori infected patients develop a range of issues including peptic
Slide 23: Colorectal Disease Test: EZ Detect
Colorectal Disease Test: EZ Detect™ eared EZ Detect is a 2-minute, at-home test for Quick & Simple: FDA the determination of fecal occult blood, an early warning sign of colorectal cancer No Stool Ha ndling B Doctor (CRC) and other colorectal diseases. recommended et COLON DISEASE | : T Interpretati
Slide 24: Key performance metrics for EZ Detect, Cologuard, & FITs
Key performance metrics for EZ Detect”, Cologuard®, & FITs FDA cleared B Doctor Value EZ Detect™) Cologuard® ?) recommended Node $22 restrictions Price $14 $649 Accuracy 93.2% 86.6% 94.7% Positive Likelihood Ratio 91.2 6.9 14.3 a Negative Likelihood Ratio 0.27 0.09 0.28 i C0 10 N Specificity (vs. al
Slide 25: Early Detection is Your Best Protection
EARLY DETECTIONS YOURBEST PROTECTION
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 breasts! Recurrent purchases and several pads for female family members 1. htt
Slide 27: Aware Performance
Aware® Performance Clinical Study Kawasaki Medical University Hospital for Aware FDA approval (N=832 Patients) 98.6% 90.9%/87.8% 86.4%/65.2% 9.8% Study concluded that Aware® is a highly effective tool Nurse 100% 96.0%/92.0% 86.4%/58.2% 4.8% for early detection of breast abnormalities Regular practic
Slide 28: EZ Detect and Aware Available at Walmart
| ez+detect’ EM Raware’ | Available at Walmart EZ Detect now in over Aware now in over Available online at 1 Walmart >< Walmart Stores Walmart Stores Available at amazon.com a Copyright © 2023 Biomerica. All Rights Reserved (23)
Slide 29: Leveraging Our Unique Technology
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 Benefits Patient / Physician / Insurer Broad IP Protection Robust patent portfolio (11 issue