Biomerica, Inc. · NASDAQ:BMRA
Biomerica — Investor Presentation (September 2016)
26 slides from Biomerica's investor presentation, Sep 12, 2016
Slide 1: Investor Presentation Sep 2016
BIOMERICA _ Investor Presentation Sep 2016
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: Investment Highlights
Investment Highlights © ¢ Simple blood test to identify foods that can alleviate IBS (Irritable Bowl Syndrome). Patent pending product with POC version to be performed in Doctors office Not a drug (No side effects/no tox) but could be combined w/ Rx Over 45 million in US suffer from IBS, over 75%* a
Slide 4: InFoods Physician's Office (Point of Care) Use
InFoods® Physician's Office (Point of Care) Use (Clinical Lab Version first to be submitted) : imFOOdS’ Simple Blood Test InFoods® Test Results 5 A + POSITIVE B NEGATIVE c NEGATIVE D + POSITIVE E NEGATIVE F NEGATIVE G NEGATIVE H + POSITIVE 1 NEGATIVE J NEGATIVE K + POSITIVE L NEGATIVE M + POSITIVE F
Slide 5: 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 (since 1989) of the ROME Committees (ROME I, ILIII and IV). Over 50 Clinical Studies for IBS & PI for major IBS drugs Recruited the o
Slide 6: 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 Corporation (Nasdaq: KLAC approx market cap: $12 billion) * Board of directors of eBay and Adobe * Former chairman, president, and CEO of Agilent
Slide 7: Companies in the IBS market
Companies in the IBS market Salix Pharmaceuticals Acq. for $15.6B Ironwood Pharmaceuticals Synergy Pharmaceuticals Biomerica (NASDAQ: SGYP) (NASDAQ: IRWD) (NASDAQ: BMRA) Market Cap*: $1.9B Market Cap*: $800MM Market Cap*: $20MM by Valeant Product: Linzess® Product: Xifaxan® Product: Product: (Linacl
Slide 8: Irritable Bowel Syndrome (IBS) Market
Irritable Bowel Syndrome (IBS) Market US PREVALENCE WORLDWIDE OF IBS! DISEASE OVER 45 MILLION OVER 14% — 1. Aliment Pharmacol Ther. 2005;21(11):1365-1375. Os oO
Slide 9: IBS Market: >45 Million in US types of IBS Market
IBS Market: >45 Million in US 3 types of IBS Market Pharmaceuticals can only focus on 1/3 of the IBS market APPROXIMATELY 33% Cc,D,M IBS — M: Closer ta 35 to 39% IBS -C Over (Constipation) IBS -D (Diarrhea) 7 5 % IBS —M (Mixed — alternates C & D) Of Sufferers Undiagnosed * Drugs can only work on IBS
Slide 10: IBS Patients
IBS Patients 0. IBS patient visit doctors 3x more than normal Affects predominantly females patients (~70% of sufferers) IBS estimated cost $30 billion in direct and indirect annually IBS sufferers incur 74% more direct healthcare costs than non-IBS sufferers Oo oO * IBS patients report that foods L
Slide 11: Models for Treatment - Key Differences
Models for Treatment - Key Differences o Rx Drugs only treat symptoms not the underlying cause Patients often cycle from one drug to another without long-term relief Side-effects are significant (e.g. Linzess®) Severe or ongoing diarrhea Severe stomach pain Black, bloody, or tarry stool gas Bloating
Slide 12: Models for Treatment - Key Differences
Models for Treatment - Key Differences Our Product: 3 key differences Retest Determine the foods to avoid Foods change to alleviate IBS symptoms * Focuses on an underlying cause Retest 2 to 3 times per year Reimbursement * Drugs = $0 * Diagnostic = Significant revenue stream to physician * CPT code
Slide 13: IP & Technology
IP & Technology Patents 17 patents pending - International Patent Application for IBS was reviewed by the ISA and all claims have been deemed novel and non-obvious. Tenney Product is specific for IBS indication ¢ Lab product - First to be submitted * Quest, Lab Corp., Mayo Clinic ¢ Doctor office pro
Slide 14: Discovery Process
90 Commonly consumed foods (wheat, corn, beef, soy, fish, nuts, etc.) First Round Discovery Process Test all foods with IBS and nhon-IBS patient sera Repeat testing; Bootstrapping and False Discovery Rate p-value adjustment 50 foods with unadjusted —— p-values <0.05 Second Round 25 foods with FDR ad
Slide 15: Technology
Technology © ¢ Each food-specific and gender-specific dataset was bootstrap resampled 1000 times. Within each bootstrap replicate, the 90th and 95th percentiles of the Control signal scores were determined. Each IBS subject in the bootstrap sample was compared to the 90th and 95% percentiles to dete
Slide 16: Technology
Technology Positive patients * — Histograms show ELISA Food A results for two foods (A&B); top half is non-IBS group, bottom half is IBS subjects Distribution of signal Saha oars Non-IBS patients * Food A shows clear elevation of a percentage of IBS IBS subjects to this food above patients the norma
Slide 17: 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 Group Median #Foods 95% Cl for the 1 00 F P <0.0001 Positive Median —— ; : — pe , . : = O4b ewe 0.01t ; IBS non-IBS BIOMERICA_> ove
Slide 18: Regulatory Pathway
Regulatory Pathway FDA is giving feedback to Biomerica on trial design FDA has indicated that the risk profile of the device is likely not a Class III * Avoids the much costlier and time-consuming PMA route....No Phase I, II or III Our pathway would not be a PMA * FDA has determined that our propose
Slide 19: First Licensing in South Korea
First Licensing in South Korea Celtis Pharma Co Ltd. South Korea h Equity investment of $1m at $3 per share Total value of up to $8.5m; minimum royalties for exclusivity $7.25m ¢ Up to $1.25 million in up front exclusivity fees i“ Territory of South Korea only + Mid-teen royalty rate on net sales of
Slide 20: Team
Team Sold Lancer Orthodontics netting a 4x return for investors Mr. Zackary Irani-Cohen Biomerica : over 8 FDA approved diagnostics CEO + Negotiated deals with BioRad, Walgreens, and multinational Pharma Co Previously with Baxter and two start-up companies that he founded. Mr. Francis Capitanio Pres
Slide 21: Dx Business
Dx Business Latest Financials 12 months INCOME STATEMENT 4 = 12 months Period Ending 31 May 16 Total Revenue 5,140 Cost of Revenue 3,616 Gross Profit 1,524 Operating Expenses R&D 780 SG&A E571. Loss from Operations -827 Other Income 31 Net Loss before Tax expense -796 Income Tax Expense -704 Net Los
Slide 22: Dx Cash Flow
Dx Cash Flow For the Years Ended May 31, ICASH FLOWS FROM OPERATING ACTIVITIES Net loss -1,499,787 -331,410 Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 232,422 253,275 Change in provision for allowance for doubtful accounts -9,063 -12,532
Slide 23: Dx Business Balance Sheet
Dx Business Balance Sheet Assets Current Assets Cash And Cash Equiv 1,889 Net Receivables 969 Inventory 1,863 Other Current Assets i4 Total Current Assets 4,835, Long Term Investments 165 Property Plant and Equipment 381 Goodwill = Intangible Assets 249 Other Assets 56 Deferred tax assets Al Total A
Slide 24: Capital Table
Capital Table Shares Percentage Name of Beneficial Owner Beneficially Beneficially Owned Owned Janet Moore 756,977 9.3% Zackary Irani 779,401 9.5% Francis Capitanio 67,000 1.0% Allen Barbieri 97,889 1.2% Francis R Cano, Ph.D. 102,836 1.3% Jane Emerson, M.D., Ph.D. 20,000 0.2% Alan Gelband, et al. 52
Slide 25: Value throughout the Healthcare system
Value throughout the Healthcare system Patients (~70% of sufferers are females) Obvious Benefits No side effects No ingestion of medication Focus on an underlying cause vs treat symptoms Substantial patient demand Easy to implement Sta Physicians Only IBS treatment that provides reimbursement to doc
Slide 26: Summary
Summary @ Unique New Diagnostic Product — Simple blood test to indentify foods that can alleviate IBS Key differentiation Reimbursement Access to entire IBS market, not just a subset Only option for IBS-M No side effects Leading Opinion Leaders in IBS on SAB guiding clinical studies Over 45 million