Biomerica, Inc. · NASDAQ:BMRA
Biomerica — Investor Presentation (January 2020)
27 slides from Biomerica's investor presentation, Jan 9, 2020
Slide 1: Investor Presentation
Presentation January 2020 | Investor ©inFoods
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
eon Who We Are cierups ey dollar markets — > Revenue generating manufacturer with FDA cleared products > Two FDA, CE, CFDAregistered manufacturing facilities in California and Mexico. Regulatory experience taking 8 products through FDA Clearance ® Diagnostic Guided Therapy (DGT) Approach @OinFoods B
Slide 4: Investment Highlights
Investment Highlights Opportunity for Investors Disciplined Share Structure: Approximately 9.5 million shares Expecting several significant milestones over next 12 months H outstanding (no warrants)* Milestones ef 14. Colorectal: Cologuard for rest of world | Management and Board owned: 2. H. Pylori
Slide 5: EZ Detect - Cologuard for the rest of the world
EZ Detect - Cologuard for the rest of the world (9 Specialty Diagnostics Business | Colorectal Disease Test EZ Detect is a 2-minute, at-home test which shows an early warning sign of colorectal cancer and other colorectal diseases > China: Signed $17 million deal over 7 years and an upfront pre-paym
Slide 6: Key performance metrics for EZ Detect, Cologuard, & FITs
Key performance metrics for EZ Detect", Cologuard®, & FITs Value | EZ Detect™ (°) Cologuard® (2) Fir) Price $12 $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 colonoscopy
Slide 7: 2020 Growth opportunity - H. pylori in Clinical Trials
2020 Growth opportunity - H. pylori in Clinical Trials Specialty Diagnostics Business Decalyieiad > GASTRIC CANCER: Alarming rate of growth in gastric cancer in US, particularly among immigrant populations in Southern California. Cancer caused by undetected and untreated H. pylori infection hp detec
Slide 8: InFoods technology - potential to disrupt a multi billion dollar market
InFoods® technology - potential to disrupt & revolutionize a multi billion dollar market There Is a Large and Growing Need Diagnostic Guided Therapy (DGT) for New Gastrointestinal Therapies to Treat GI Diseases » Designedto allow physicians to identify Baton’: allowed patient specific foods (e.g. eg
Slide 9: Our Pipeline
Our Pipeline Q)inFoods” Functional Gastrointestinal Disorders IBS Irritable Bowel Syndrome 2. Functional Dyspepsia » GERD Gastroesophageal reflux disease Gastrointestinal Diseases Ulcerative Colitis 5. Crohn's QinFoods | siomericA>
Slide 10: InFoods IBS Product - Irritable Bowel Syndrome
InFoods® IBS Product - Irritable Bowel Syndrome A Multi-Billion Dollar Market Opportunity in Clinical studies First ever diagnostic guided therapy for Irritable Bowel Syndrome (IBS) - Simple blood test to identify patient specific foods that alleviate IBS symptoms InFoods® therapy InFoods® IBS Thera
Slide 11: IBS Market: types of IBS
IBS Market: > 45 Million in US 3 types of IBS A drug can only focus on 1/3 of the IBS market QiinFoods | siomerica IBS - C (Constipation) IBS - D (Diarrhea) Approximately No approved 33% Cc, D, M therapy/drug for IBS-M > Drugs can only work on IBS-C or IBS-D > They can't do both (IBS-M)
Slide 12: IBS Patients
IBS Patients IBS patients visit doctors 3x more than normal patients > IBS costis estimated at $30 billion annually in direct and indirect > IBS sufferersincur 74% more direct healthcare costs than non-IBS sufferers Majority of IBS patients believe that foods trigger their symptoms > Patients desper
Slide 13: Irritable Bowel Syndrome (IBS) Market
Irritable Bowel Syndrome (IBS) Market Worldwide Prevalence Of Disease Cy ve) US'14% OVER 45 MILLION IBS Sufferersin US at 14% of population OVER 825 MILLION Sufferers Globally (at est. 11% of population) 41. Aliment Pharmacol QiinFoods | siomeRicA>
Slide 14: Food, the Microbiome, and GI Illness
Food, the Microbiome, and Gl Illness dibs Microbial environmentin the intestines and diet play a role in the etiology & rence predisposition to development of Glillness such as IBS; similar inflammatory pathways activated in IBD, but with less severe symptoms Success in IBS-D? (using Biomerica 1st G
Slide 15: Scientific Advisory Board & ROME Foundation
Scientific Advisory Board & ROME Foundation Dr. Doug Drossman (SAB Chair) US board members of ROME foundation & Dr. Tony Lembo ROME foundation (Leading IBS group - not for profit) ©iinFoods | siomericA> Dr. Doug Drossman (President of the ROME foundation) leading opinion leader in IBS Chair of ROME
Slide 16: Competing therapies in the IBS market
Competing therapies in the IBS market Ironwood Pharmaceuticals (NASDAQ: IRWD) Market Cap*: $1.98 Salix Pharmaceuticals Acq. for $11Bil by Bausch Health Cos Biomerica (NASDAQ: BMRA) Market Cap*: $30MM Product: InFoods® IBS > IBS.C > Pl's: Two members of ROME foundation > Side effects: Diarrhea, Abdom
Slide 17: FDA Approval - Thresholds
FDA Approval - Thresholds FDA Treatment Placebo Deltavs pnouaized Indication Approval | Response Response Placebo ue Comments uc ue i Sales (M) Linzess 2012 20% - 34% 6% - 27% Th = 14% $382 s7e1* > Diarrhea side effect (20%) IBs-c 9 = > Indicated forwomen only; not Amitiza 2008 14% 8% 8% $380 $450 d
Slide 18: Stool Frequency: Drug Therapy vs. Diet-Guided Therapy
| J lomerica t- Stool tranay 1M _otronex™ Stool Frequency. Response to Drug Therapy vs. Diet-Guided Therapy in IBS-D: vs. Alosetron (Lotronex™) Stool frequenc 0-2 iday, O points: 3-4 timesiday, 1 56 timesiday, 2 27 timesiday, 3 points. red as 00! frequency (#/day) —-Alosetron Biomerica First Gen Ind
Slide 19: Stool Consistency: Drug Therapy vs. Diet-Guided Therapy
_otronex™ | t - Stool Stool Consistency - Response to Drug Therapy vs. Diet-Guided Therapy in IBS-D: vs. Alosetron (Lotronex 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 p
Slide 20: Regulatory Pathway IBS
Regulatory Pathway IBS FDA has determined that our proposed IBS clinical study is a nonsignificant risk (NSR) Enrolling patients at Beth Israel (Harvard); Univ. of Michigan. New GI Group added May 2019 > Avoids the much costlier and time-consuming PMA route (No Phase |, Il or Ill) IP&Data = > pes Le
Slide 21: InFoods Advantages
InFoods® Advantages | The InFoods® Key differences InFoods® focuses on underlying cause of IBS Reimbursement to Doctor > Drugs = $0 > Diagn arge revenue potential © CPT insurance reimbursement code already e Ability to use on all 3 types of IBS > Targets 100% of the IBS market (not just 1/3) > Would
Slide 22: Revenue Drivers for InFoods
Revenue Drivers for InFoods® Ament Pharmacol Ther. 2005;:21(11):1365-1375 ital Indeper in Ep marketing research company QinFoods | siomericA> 45 million’ treatable IBS patients in the US 127 million? Americans, (28.7%) of IBS patients in the US, seek physician treatment consistently Physicians could
Slide 23: Expecting significant milestones over next 12 months
Expecting significant milestones over next12 months 1. Colorectal 2. H. Pylori 3. InFoods"iBS QiinFoods | siomeRicA> New InFoods. IBS therapy — identify foods that can alleviate IBS Key differentiation Reimbursement to Physician Atherapy that could replace or be combined with drug treatment Treats t
Slide 24: Technology
Technology Food A shows clear elevation of a percentage of IBS subjects to this food above the normal range; Food B does > Histograms show ELISA re for two foods (A&B); top half is non-IBS group, bottom half is IBS Ss NonJBS patients 4 cutot IBS patients QiinFoods | siomerica Cutoff would be setto c
Slide 25: Technology: IBS Patients vs. non-IBS Controls
Technology: IBS Patients vs. non-IBS Controls: # of Positive Foods Median # of Positive Foods Box and Whisker Plot IBS vs. non-IBS P<0.0001 Non.IBS QiinFoous | siomeriGa
Slide 26: Strategic Advisory Board
Strategic Advisory Board & Dr. Ned Barnholt f Chairman of KLA-Tencor; Former CEO and Chairman of Agilent Technologies Dr. Harry Leider > Former Chief Medical Officer of Walgreens Dr. Mark Sirgo S Former Board of Directors member & Chairman of the Compensation Committee of > Salix Pharmaceuticals ©ii
Slide 27: IP & Technology
IP & Technology A ‘i Patents 2 patents allowed and 15 patents pending — Key International Patent Application was reviewed by the ISA and all claims were deemed novel and non-obvious. EA First Patents Allowed > Korean Patent No. 10-1887545 August 6, 2018. Title: Compositions, Devices & Methods of IBS