Biomerica, Inc. · NASDAQ:BMRA
Biomerica — Investor Presentation (November 2021)
23 slides from Biomerica's investor presentation, November 2021
Slide 1: Investor Presentation
Investor Presentation Investor Presentation November 2021 NASDAQ: BMRA
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 Using Science, Diet and Technology to Revolutionize the GI Market
Diagnostic Guided Therapy Using Science, Diet and Technology to Revolutionize the GI Market 3
Slide 4: Investment Highlights
Investment Highlights Disruptive platform technology redefining the GI Market First ever FDA-regulated diagnostic therapy Large Growing Market: $30+ Billion expansive market opportunity Robust patent portfolio (9 issued patents; 100+ patents pending) Significant milestones driving growth: - InFoods®
Slide 5: Leadership Team and Board
Leadership Team and Board Management Scientific Advisory Board InFoods® Principal Investigators Principal Investigators or Collaborators for: WILLIAM CHEY, MD, AGAF, FACG, FACP ZACK IRANI DOUGLAS DROSSMAN, MD • Chief Executive Officer & • President Emeritus, Rome • University of Michigan – Ann Arbor
Slide 6: Background & Innovation
Background & Innovation Specialty diagnostics enabling early disruptive patented technology disease detection and monitoring platform enabling diagnostic therapies • Two FDA, CE, CFDA registered • Redefining the treatment of GI diseases manufacturing facilities in California and Mexico • Also applic
Slide 7: InFoods – Diagnostic Guided Therapy (DGT) to Treat Chronic Inflammatory Diseases
InFoods® – Diagnostic Guided Therapy (DGT) to Treat Chronic Inflammatory Diseases Example of Patient-Specific Results Food Result Blueberry + POSITIVE Chicken NEGATIVE Cabbage NEGATIVE Egg + POSITIVE Garlic NEGATIVE • FDA-regulated diagnostic to be used as therapy Lemon NEGATIVE • Measures immunorea
Slide 8: IBS Patients: Significant Unmet Medical Need
IBS Patients: Significant Unmet Medical Need IBS is the IBS is the #7 most common diagnosis #1 most common diagnosis made by made by gastroenterologists1 all physicians1 IBS sufferers have IBS patients visit doctors 3x more 74% more than non-IBS patients direct healthcare costs vs. non-IBS sufferers
Slide 9: Large and Growing Irritable Bowel Syndrome (IBS) Market
Large and Growing Irritable Bowel Syndrome (IBS) Market M D C 40 MILLION IBS Patients $30B+ IBS-C (Constipation) | IBS-D (Diarrhea) | IBS-M (Mixed: Alternates C+D) U.S. TAM1 ~12 MILLION ~13 MILLION IBS Patients seeking consistent IBS-M Patients: physician treatment No approved therapy/drug2 9 1. Glo
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 Benefits InFoods® targets underlying causes InFoods®: Recurring revenue potential IBS Patients require 3x doctor visits withou
Slide 11: FDA Approved Therapies are Expensive and have Efficacy and Safety Limitations
FDA Approved Therapies are Expensive and have Efficacy and Safety Limitations Drug Drug Annualized FDA Placebo minus Monthly Indication Drug Treatment U.S. Limitations Approval Response Placebo Cost Response Sale Response › Diarrhea side effect Linzess 2012 20% - 34% 6% - 27% 7% - 14% $467 $1,963M (
Slide 12: Biomerica First-Generation Product vs. Lotronex: Stool Frequency
Biomerica First-Generation Product vs. Lotronex™ (Diarrhea Stool Frequency: an FDA endpoint) IBS-Diarrhea 120% (% change from baseline) 100% Stool Frequency 80% Alosetron (Lotronex™) Drop from Baseline: 30% 60% 40% Biomerica First-Gen Product Drop from Baseline: 65% 20% 0% 0 2 4 6 8 10 12 14 Week Al
Slide 13: Regulatory Pathway for InFoods IBS
Regulatory Pathway for InFoods® IBS IP & Data Product Dev. R&D FDA Sub Q Endpoint Trial Pivotal Trial FDA Approval 1. final patient treatment 12 – 14 months 2. Top line results • FDA has indicated InFoods® IBS will be evaluated as a therapy • FDA has determined proposed IBS clinical study is a non-s
Slide 14: InFoods Commercialization Strategy
InFoods® Commercialization Strategy Multiple Avenues to Drive Adoption Reimbursement Inclusion in Guidelines Awareness and Broad Physician Interest Enhanced Coverage • Inclusion in the IBS treatment • Help GI physicians monetize their • Capitalize on strong physician guidelines will accelerate produ
Slide 15: SAB: Key Members of the Rome Foundation-Expertise on IBS Clinical Trials
SAB: Key Members of the Rome Foundation-Expertise on IBS Clinical Trials • Leading independent non-profit organization focused on the diagnosis and treatment of functional gastrointestinal disorders, Rome Foundation including IBS (Leading IBS organization) • Rome creates the diagnostic criteria and
Slide 16: Platform Technology: InFoods IBS Development Pipeline
Platform Technology: InFoods® IBS Development Pipeline (potential to address multiple disease states) Product Dev. IP & Data FDA Sub Q End Point Trial Pivotal Trial Approval R&D Irritable Bowel Syndrome (IBS) Functional Gastrointestinal Functional Dyspepsia Disorders Gastroesophageal reflux disease
Slide 17: Specialty Diagnostics
eee Specialty Diagnostics COLON SCREENING gg DISEASE TEST TEST signs of colorectal disease
Slide 18: 2021 Growth opportunity - H. pylori
2021 Growth opportunity - H. pylori Specialty Diagnostics Business Detects H. pylori Antigen H. pylori is a bacteria that infects approximately 35% of the Gastric Cancer: Gastric cancer is the 3rd most common U.S. population and 45% of the population in the five major cause of cancer related death i
Slide 19: Colorectal Disease Test: EZ Detect
Colorectal Disease Test: EZ Detect™ Specialty Diagnostics Business 1 Interpretation EZ Detect is a 2-minute, at- home test for the determination of fecal occult 2 Negative blood, an early warning sign of colorectal cancer (CRC) and other colorectal diseases. 3 Positive Positive Any color in the test
Slide 20: Key performance metrics for EZ Detect, Cologuard, & FITs
Key performance metrics for EZ Detect , Cologuard , & TM ® 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 colon
Slide 21: EZ Detect: Available at Walmart Now in over 4,600 Walmart Stores
EZ Detect™: Available at Walmart Specialty Diagnostics Business Now in over 4,600 Walmart Stores 21
Slide 22: COVID Proof-Point: Strong and Adaptable Platform
COVID Proof-Point: Strong and Adaptable Platform • Leveraged expertise in specialty diagnostics to rapidly and seamlessly develop COVID serology test • Highlights Biomerica’s unique capabilities and the adaptable, serology based platform technology of InFoods® • Testament to strength of the Company’
Slide 23: Leveraging Our Unique Assets to Scale & Optimize Our Business
LEVERAGING OUR UNIQUE ASSETS TO SCALE & OPTIMIZE OUR BUSINESS REVOLUTIONARY TECHNOLOGY NEAR-TERM MILESTONES Addressing Large Need for IBS InFoods® Endpoint Study Patients, then Targeting hp+detect launch Multiple Other Diseases ez+detect INFOODS® MODEL FINANCIALLY ATTRACTIVE Unique Benefit to Low Bu