Biomerica, Inc. · NASDAQ:BMRA
Biomerica — Investor Presentation (February 2022)
23 slides from Biomerica's investor presentation, February 2022
Slide 1: Investor Presentation February 2022
Investor Presentation February 2022 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 (9 issued patents; 100+ patents pending) Investment Significant Milestones Driving Growth Highlights
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 disease detection and monitoring platform enabling diagnostic therapies Two FDA, CE, CFDA registered manufacturing Redefining
Slide 7: InFoods – Diagnostic Guided Therapy 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 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% IBS patients visit doctors 3x more direct healthcare more than non-IBS patients costs vs. non-I
Slide 9: IBS Market is Significant Today and Growing
IBS Market is M Significant Today and Growing 40 Million IBS Patients in the US $30B+ D C U.S. TAM1 1/3 IBS-C 1/3 IBS-D 1/3 IBS-M (Mixed: (Constipation) (Diarrhea) Alternates C+D) ~12 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 poten
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 minus FDA Placebo Monthly Annualized Indication Drug Treatment Placebo Limitations Approval Response Cost U.S. Sale Response Response • Diarrhea side Linzess 2012 20% - 34% 6% - 27% 7% - 14% $467 $1,963M effect (
Slide 12: Biomerica First-Generation Product vs. Lotronex
Biomerica First-Generation Product vs. Lotronex™ (Diarrhea Stool Frequency: an FDA endpoint) IBS-Diarrhea Alosetron Food IgG 120% (% change from baseline) 100% Alosetron (Lotronex™) 30% Stool Frequency Drop from Baseline: 80% 60% 40% 65% Biomerica First-Gen Product 20% Drop from Baseline: 0% 0 2 4 6
Slide 13: InFoods Regulatory Pathway
InFoods® Regulatory Pathway IP & Data Product Dev. R&D FDA Sub Q End Point Trial Pivotal Trial FDA Approval 1. final patient treatment 12 – 14 months 2. Top line results FDA has indicated InFoods® IBS will FDA has determined proposed IBS Endpoint Trial is complete: Goal of be evaluated as a therapy
Slide 14: Highlights InFoods IBS Top Line Endpoint Select Results
Highlights Statistically meaningful improvements InFoods® IBS were seen in multiple endpoints (symptoms), this is only a selection of Top Line Endpoint Select Results topline results from the InFoods® IBS endpoint trial P-value of 0.007 for improvement in the Subject Global Assessment of Relief (SGA
Slide 15: 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 16: SAB: Rome Foundation - Sets IBS Guidelines, Expertise in Clinical Trials
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 17: 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 18: Specialty Diagnostics
Specialty Diagnostics Copyright © 2022 Biomerica. All Rights Reserved 18
Slide 19: 2022 Growth opportunity - H. pylori
2022 Growth opportunity - H. pylori Status: Biomerica is targeting to have its H. pylori clinical studies completed, and FDA 510K submission filed by end of March, 2022. Initial sales planned in summer 2022. Detects H. pylori Antigen Gastric Cancer: Gastric cancer is the 3rd most common cause of can
Slide 20: 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 21: Key performance metrics for EZ Detect, Cologuard, & FITs
Key performance metrics for EZ DetectTM, 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 colonosco
Slide 22: EZ Detect: Available at Walmart
EZ Detect™: Available at Walmart Now in over 4,600 Walmart Stores Copyright © 2022 Biomerica. All Rights Reserved 22
Slide 23: 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 (9 issued patents; 1