Biomerica, Inc. · NASDAQ:BMRA
Biomerica — Investor Presentation (September 2018)
26 slides from Biomerica's investor presentation, Sep 28, 2018
Slide 1: Corporate Presentation Sep 2018
©)inFoods Corporate Presentation Sep 2018
Slide 2: Forward looking Statements
BIOMERICA_> 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
Slide 3: Investment Highlights: Who We Are
Investment Highlights ~ Who We Are Experienced, revenue generating manufacturer with FDA cleared products Contract manufacturer for Bio-Rad, 2 multinational pharma’s and other leading organizations Two FDA registered manufacturing facilities in California and Mexico Regulatory experience taking 8 pr
Slide 4: Investment Highlights: Opportunity for Investors
Investment Highlights ~ Opportunity for Investors Biomerica (Nasdaq: BMRA) $32 million Market Cap* Growing legacy business provides ascending downside protection InFoods IBS therapy is a multi billion dollar potential Short time horizon for possible licensing and FDA approvals Disciplined Share Stru
Slide 5: Legacy Business
Legacy Business Manufacturer of 20 difficult-to-produce, specialty diagnostic products Opportunities for growth in several legacy products * Colorectal Disease test - internationally * other POC products - internationally ¢ H. pylori Ag US & Intl. market demand (in clinical trials) Regulatory experi
Slide 6: Legacy Diagnostic Business Growth Opportunity
Legacy Diagnostic Business Growth Opportunity _ Interpretation | > EZDetece (| weaative | | ° * Positive EZ Detect’ S | Positive (e| C= fos ani shia conatduecies a positive result L ] EZ Detect is a 2-minute, at-home test which shows possible early warning sign of colorectal cancer and other colorec
Slide 7: EZ Detect: International Markets
EZ Detect: International Markets poh Colorectal Screening saves $ and lives Particularly attractive in countries Decrease of 66 cancer deaths per where government funds all 1,000 persons screened over 30 years. healthcare. Can reduce number of colonoscopies performed we . . China and Mexico have rec
Slide 8: Pipeline Products: H. pylori in Clinical Trials
Pipeline Products Helicobacter pylori (H. Pylori) in Clinical Trials poh United States: Approx. one-third of Biomerica is in Clinical studies at the adults are infected with H. pylori. University of Southern California (USC), Infection rate is higher in Southern and Vanderbilt University, and a Euro
Slide 9: Pipeline Products: InFoods IBS Diagnostic Therapy
Pipeline Products InFoods IBS Diagnostic Therapy - in clinical studies ~~~ IBS: A Multi-Billion Dollar Market Opportunity First ever diagnostic guided therapy for Irritable Bowel Syndrome (IBS) - Simple blood test to identify patient specific foods that alleviate IBS symptoms 45 Million IBS patients
Slide 10: IBS Market: >45 Million in US types of IBS
IBS Market: >45 Million in US 3 types of IBS IBS -C (Constipation) IBS —D (Diarrhea) IBS —M (Mixed) alternates C & D BIOMERICA_> Market APPROXIMATELY 33% C,D,M No approved therapy/drug for IBS-M A drug can only focus on 1/3 of the IBS market D + Drugs can only work on IBS-C or IBS-D * They can't do
Slide 11: IBS Patients
IBS Patients Jt 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-IBS sufferers Majority of IBS patients believe that foods trigger their symptoms * Patients d
Slide 12: Food, the Microbiome, and GI Illness
Food, the Microbiome, and Gl Illness Bile acid Microbial environment in the intestines and diet ey | \ © 6 ice 8° wo s play a role in the etiology & predisposition to ee alt a eH development of Gl illness such as IBS; similar 2 © Foodpanicte Ney inflammatory pathways activated in IBD, but with Intes
Slide 13: InFoods Physician's Office (Point of Care) Use
InFoods® Physician's Office (Point of Care) Use (Clinical Lab Version will also be available) © inFoods [8S Therapy © iNFOOOS ® Results Food Result A + POSITIVE B NEGATIVE C NEGATIVE D + POSITIVE E NEGATIVE F NEGATIVE G NEGATIVE H + POSITIVE | NEGATIVE J NEGATIVE K + POSITIVE L NEGATIVE M + POSITIVE
Slide 14: Companies in the IBS market
Companies in the IBS market Ironwood Pharmaceuticals Salix Pharmaceuticals Synergy Pharmaceuticals | (NASDAQ: IRWD) (NASDAQ: SGYP) Market Cap*: $2.8B Product: Linzess® Ironwood owns 50% of Linzess IBS-C PI's: wo members of ROME foundation Side effects: Diarrhea, Abdominal Pain, Flatulence, Headaches
Slide 15: Scientific Advisory Board & ROME foundation
Scientific Advisory Board & ROME foundation Dr. Doug Drossman (SAB Chair) = + Dr. Doug Drossman (President of the ROME foundation) leading opinion leader in IBS = Chair of ROME since 1989 = Participated in 50+ Clinical Studies for IBS = Has been PI for major IBS drugs Recruited the other 3 US member
Slide 16: Strategic Advisory Board & Dr. Mark Sirgo
Strategic Advisory Board & Dr. Mark Sirgo Ned Barnholt Chairman of KLA-Tencor; Former CEO and Chairman of Agilent Technologies <= Chairman KLA-Tencor (Nasdaq: KLAC market cap: ~$16 billion) Board of directors of eBay and Adobe Former Chairman/CEO of Agilent Technologies (leading company in life scie
Slide 17: Regulatory Pathway
Regulatory Pathway Biomerica is working with FDA on trial design FDA has determined that our proposed clinical study is a nonsignificant risk (NSR) * Avoids the much costlier and time-consuming PMA route (No Phase |, II or III) Our pathway: 510(k) de novo * De Novo pathway: novel lower-risk (for Cla
Slide 18: FDA Approval - Thresholds
FDA Approval - Thresholds Pharmacotherapy Treatment Placebo Difference Responders % | Responders % m Amitiza IBS-C 14% 8% 6% m Linzess (study A) IBS-C 34% 27% 7% Linzess (study B ) 20% 6% 14% m Viberzi IBS-D 25% 17% 8% BIOMERICA_> 0%0
Slide 19: InFoods Advantages
InFoods Advantages ae Rx Drugs only treat symptoms not the underlying cause The InFoods’ Key differences InFoods® focuses on underlying cause of IBC Reimbursement to Doctor * Drugs = $0 * Diagnostic = Large revenue potential Y CPT insurance reimbursement code already exists Ability to use on all 3 t
Slide 20: IP & Technology
IP & Technology Patents 17 patents pending — Key International Patent Application was reviewed by the ISA and all claims were deemed novel and non- obvious. First Patent Issued: Korean Patent No. 10-1887545 Issue Date: August 6, 2018 Title: COMPOSITIONS, DEVICES, AND METHODS OF IBS SENSITIVITY TESTI
Slide 21: Irritable Bowel Syndrome (IBS) Market
Irritable Bowel Syndrome (IBS) Market WORLDWIDE PREVELANCE OF DISEASE BRAZIL 25% re OVER 45 MILLION IBS Sufferers in US at 14% of population OVER 825 MILLION Sufferers Globally (at est. 11% of population) ICA > 1. Aliment Pharmacol Ther. 2005;21(11):1365-1375. BIOMERIC, 9 206
Slide 22: Revenue Drivers for InFoods
Revenue Drivers for InFoods° US Market Only * 45 million’ treatable IBS patients in the US * 12.7 million? Americans, (28.7%) of IBS patients in the US, seek physician treatment annually * Physicians could perform the InFoods test in-office, and generate revenue for their office * Inarecent survey’,
Slide 23: Existing Diagnostic Business: Financials
Existing Diagnostic Business Financials FYE 2018 and 2017 INCOME STATEMENT . . . , . 12 months 12 months Period Ending (in 1000's) (unaudited) May 18 May 17 Total Revenue 5,564 5,792 Cost of Revenue 3,810 3,770 Gross Profit 1,754 2,022 R&D 1,398 1,131 SG&A 1,838 1,846 Loss from Operations -1,482 -95
Slide 24: Diagnostic Business Balance Sheet
Diagnostic Business Balance Sheet Assets (in 1000’s) (unaudited) Current Assets Cash And Cash Equiv 1,205 Net Receivables 800 Inventory 2,179 Other Current Assets 300 Total Current Assets 4,484 Long Term Investments 165 Property Plant and Equipment 351 Intangible Assets 99 Other Assets 114 Deferred
Slide 25: Summary
Summary oy Growing legacy business provides ascending floor for valuation 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 symptom No side effects Ac
Slide 26: First Licensing in South Korea
First Licensing in South Korea Celtis Pharma Co Ltd. South Korea NX Total value of up to $8.5m; minimum royalties for exclusivity $7.25m * Up to $1.25 million in up front exclusivity fees Equity investment of $1m at $3 per share iN Territory of South Korea only * Mid-teen royalty rate on net sales o