Biomerica, Inc. · NASDAQ:BMRA
Biomerica — Investor Presentation (September 2020)
22 slides from Biomerica's investor presentation, Sep 2, 2020
Slide 1: Investor Presentation September 2020
Investor Presentation September 2020 OinFoods | BIOMERICA
Slide 2: Forward looking statements
Forward looking statements 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)
Slide 3: Who We Are
Who We Are q 5 5 New technology platform has the potential to Specialty Diagnostics disrupt and revolutionize a multi billion- Company dollar markets > Revenue generating manufacturer with FDA cleared products > Two FDA, CE, CFDA registered manufacturing facilities in California and Mexico. Regulato
Slide 4: Investment Highlights
Investment Highlights Opportunity for Investors Expecting several significant milestones over next 12 months Milestones 1. COVID-19 antibody tests 2. InFoods” IBS Diagnostic Guided Therapy Short time horizon for possible licensing and FDA clearance @inFoods | siomeRIcA> *As of May 2020 Disciplined S
Slide 5: COVID-19 Antibody testing
COVID-19 Antibody testing Specialty Diagnostics Business Point of Care | Cassette & Card > CE marked test: Marketed in Europe and the rest of the world. > Biomerica’s rapid point of care test showed 100% sensitivity and 100% specificity (Published in Diagnostics 2020, 10, 453; July 2020) Laboratory
Slide 6: InFoods - Diagnostic Guided Therapy (DGT) to Treat Chronic Diseases
InFoods® - Diagnostic Guided Therapy (DGT) to Treat Chronic Diseases We leverage our diagnostics expertise to transition to therapeutic applications with Diagnostic Guided Therapy (DGT) Potential to disrupt multi billion dollar markets © inFoods” @OinFoods | siomeRIcA> FDA-regulated diagnostic to be
Slide 7: InFoods IBS Product - Irritable Bowel Syndrome
InFoods” IBS Product - Irritable Bowel Syndrome n Dollar Market. Currently in Clinical Trials ibeod mls ibetae) InFoods® therapy helps address (=) the problem not just the symptoms @©)inFoods * First ever diagnostic guided therapy for Irritable Bowel Syndrome (IBS) * Simple blood test to identify pa
Slide 8: ~40M IBS Patients in US with ~12M Actively Managed, 1/3 of Whom Have No Available Therapy
~40M IBS Patients in US with ~12M Actively Managed, 1/3 of Whom Have No Available Therapy 3 types of IBS Patient Population Current drugs can only focus on 1/3 of the IBS market IBS - C (Constipation) IBS - D (Diarrhea) * ~40 million’ IBS patients in the US * ~13 million? seek physician treatment co
Slide 9: IBS Patients Represent a Significant Unmet Medical Need
IBS Patients Represent a Significant Unmet Medical Need IBS patients visit doctors 3x more than normal patients > IBS cost is estimated at $30 billion annually in direct and indirect > IBS sufferers incur 74% more direct healthcare costs than non-|BS sufferers Majority of IBS patients believe that f
Slide 10: FDA Approved Therapies Are Expensive and Achieve Significant Sales
FDA Approved Therapies Are Expensive and Achieve Significant Sales Despite Limited Efficacy and Potentially Severe Adverse Events ee FDA Treatment Placebo paced Monthly eoriualized er Indication Subtracted U.S. Limitations Approval Response Response Cost* Response Sales Linzess 2012 20% - 34% 6% - 2
Slide 11: Food, the Microbiome, and GI Illness
Food, the Microbiome, and Gl Illness The environment in the intestines an diet play a role in the etiology & predisposition to development of Gl illness such as Irritable Bowel Syndrome (IBS). Similar inflammatory pathways activated in Inflammatory Bowel Disease (IBD - Crohn's or Ulcerative Colitis)
Slide 12: Clinical Studies Validate Immunoreactivity Based Diet Modification
Clinical Studies Validate Immunoreactivity Based Diet Modification Several clinical studies have validated the diet modification approach to improve IBS and IBD symptoms Adult IBS" > 150 outpatients with IBS were randomized to receive a diet excluding all foods to which they had raised IgG antibodie
Slide 13: First-Gen Biomerica Device in IBS and IBD
First-Gen Biomerica Device in IBS and IBD Clinical studies using a first-gen Biomerica device have demonstrated improvement in IBS and IBD symptoms in trials. IBS-D' (using Biomerica 1st Gen Product) > 77 patients with 12-week specific-food exclusion diets resulted in significant improvements in abd
Slide 14: Stool Frequency: Response to Drug Therapy vs. Diet-Guided Therapy in IBS-D
Stool Frequency. Response to Drug Therapy vs. Diet-Guided Therapy in IBS-D: vs. WEEK Alosetron Food IgG Independent studies: Ther Adv Gastroenterol 2018, Vol. 11: 1-11 J Int Med Res. 2012;40(1):204-10. NX OiinFoods
Slide 15: Stool Consistency - Response to Drug Therapy vs. Diet-Guided Therapy in IBS-D
Stool Consistency - Response to Drug Therapy vs. Diet-Guided Therapy in IBS-D: vs. Alosetron (Lotronex™) Biomerica Fi Biomerica First Generation Product: Stool shape-used the Bristol Stool Scale as its basis, scoring as: 0 points- smooth and soft feces; 1 point-soft dough, with clear edge; 2 points-
Slide 16: Regulatory Pathway
Regulatory Pathway + FDA has indicated that the product will be evaluated as a therapy. + FDA has determined that proposed IBS clinical study is a nonsignificant risk (NSR), which avoids the much costlier and time-consuming PMA route (No Phase |, Il or Ill). * Ongoing Endpoint Trial is currently enr
Slide 17: Development Pipeline
Development Pipeline ——- —— ae —— — Product Dev. End Point Pivotal IP&Data_ es > FDAsubq > Pais He > Approval License Out Irritable Bowel Syndrome (IBS) Functional Dyspepsia Gastroesophageal reflux disease (GERD Ulcerative C Functional Gastrointestinal Disorders Gastrointestinal Diseases Inflammator
Slide 18: Scientific Advisory Board
Scientific Advisory Board WILLIAM CHEY, MD, AGAF, FACG, FACP + Professor GI & Nutrition Sciences, Univ. of Michigan + Rome Board member * Co-Director Michigan Bowel Program * Pl for Linzess®, Viberzi®, Xifaxan® DOUGLAS DROSSMAN, MD + President Emeritus, Rome Foundation Co-Director Emeritus, UNC Cent
Slide 19: 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 creating Special Issue \ scientific data and educational information to assist in the diagnosis Gastroenterolo ROME foundation and treatment of functional gastrointestina
Slide 20: InFoods Advantages
InFoods* Advantages Reimbursement to physicians > Drugs = $0 > Diagnostic = Large practice revenue potential CPT insurance reimbursement code already exists Ability to use on all types of IBS > Targets 100% of the IBS market > Would be the only therapeutic option for IBS-M Can be used as combination
Slide 21: Potential Market for InFoods
Potential Market for InFoods’ > ~40M IBS patients in the US) 12% of the population! > 28% of IBS patients seek physician treatment, translating to an immediately addressable market of ~12M patients? > In a recent survey’, primary care physicians estimated using InFoods® therapy on >90% of their IBS
Slide 22: Summary
Expecting significant milestones over next 12 months 15) GOVIDAI) 2. InFood® IBS Summary New InFoods. IBS therapy -— identify foods that can alleviate IBS > Key differentiation > Reimbursement to Physician > A therapy that could replace or be combined with drug treatment > Treats the cause not the s