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Investor PresentationDecember 2021Copyright 2021 Biomerica. All Rights Reserved
Forward-Looking StatementThe Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain information included in this presentation (as wellas information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking, includingstatements other than statements of historical facts; such as statements relating to intended launch dates, sales potential, significant benefits, market size, number ofsufferers with IBS, prospects, new products, favorable outlook, efficacy of competing products, the FDA pathway, expansion, increases in productivity and margins,expected orders, market competition, anticipated future sales, possible future revenues including InFoods revenue opportunities, possible FDA or other regulatoryclearances, insurance reimbursement availability and amounts, physician adoption rates, physician pricing, patent protection of the InFoods technology, frequency ofpatient testing, production volume of the Company, the launch or success of current and new product offerings; as well as statements relating to the Company’s testsincluding; the efficacy of InFoods IBS at treating IBS symptoms in patients, accuracy of the InFoods product at detecting correct foods causing patient IBS symptoms,results of studies testing the efficacy and accuracy, FDA clearance, EUA clearance including CE Mark, the rapidity of testing results, uniqueness of these tests, useand commercial adoption of these tests, pricing of the Company’s test kits, domestic and international demand and orders, the Company’s manufacturing capacity,patent protection, and all regulatory approvals necessary prior to commercialization of these tests; and, resource and other constraints on our suppliers; dependenceon our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; competition from other similar products andfrom competitors that have significantly more financial and other resources available; governmental virus control regulations that may make it difficult or impossible forthe company to maintain current operations; and any other aspect of the Company’s Tests. Such forward-looking information involves important risks anduncertainties that could significantly affect anticipated results in the future, and accordingly, such results may differ materially from those expressed in any forwardlooking statements made by or on behalf of Biomerica. Forward looking statements also include the assumptions underlying or relating to such statements. Theunderlying assumptions could prove to be inaccurate or known or unknown risks or uncertainties could materialize, therefore actual results could vary materially. Thepotential risks and uncertainties include, among others, fluctuations in the Company’s operating results, downturns in international and or national economies, theCompany’s ability to raise additional capital as needed, the competitive environment in which the Company will be competing, and the Company’s dependence onstrategic relationships and on regulatory approvals. A further list and description of these risks, uncertainties and other factors can be found in our report on Form 10K filed with the Securities and Exchange Commission on August 31, 2021. Any forward-looking statements made in this presentation speak only as of the date of thepresentation. The Company is under no obligation to update any forward-looking statements after the date of this presentation.Copyright 2021 Biomerica. All Rights Reserved2
Diagnostic Guided TherapyUsing Science, Diet and Technologyto Revolutionize the GI MarketCopyright 2021 Biomerica. All Rights Reserved3
Disruptive Patented Platform Technologyredefining the GI MarketFirst ever FDA-regulated diagnostic therapyLarge Growing Market 30 Billion expansive market opportunity Robust patent portfolio (9 issued patents; 100 patents pending)InvestmentHighlightsSignificant Milestones Driving Growth InFoods IBS clinical trial complete H. Pylori antigen test launch ez detect – Colon Disease TestConservative Capital Structure 18% Insider ownership No warrants, no preferred equity and no debtDepth of Scientific Leadership SAB Leadership includes US Members of the Rome Foundation Clinical studies lead by principal investigators whoset GI “treatment guidelines”Copyright 2021 Biomerica. All Rights Reserved4
Leadership, Board & Depth in ScienceManagementScientific Advisory BoardPrincipalInvestigators orCollaborators for:ZACK IRANI Chief Executive Officer & ChairmanPrevious CEO & Chairman of LancerOrthodontics Inc.DOUGLAS DROSSMAN, MD ALLEN BARBIERI Executive Vice ChairmanPrevious CEO of numerous public andprivate companiesBoard member at CareTrust REITSTEVE SLOAN Chief Financial OfficerPreviously held various roles atGeneral Electric and MedtronicBoard of DirectorsPresident Emeritus,Rome FoundationCo-Director Emeritus, UNC Center forFunctional GI and Motility DisordersLIN CHANG, MD Professor of Medicine, UCLA, Divisionof Digestive DiseasesRome Board memberServed on FDA GI advisory panelWILLIAM CHEY, MD, AGAF,FACG, FACP Professor GI & Nutrition Sciences,Univ. of MichiganRome Board memberCo-Director Michigan Bowel ProgramWILLIAM WHITEHEAD, PHDCathy Coste, CPAJane Emerson, MD, PhDInFoods Principal Investigators Director, UNC Center for Functional GIand Motility DisordersANTHONY LEMBO, MD Mark Sirgo, PharmD Harvard Medical & Beth IsraelDeaconess Medical CenterAssociate Editor of Journal of ClinicalGastroenterology and DigestiveDiseases and ScienceWILLIAM CHEY, MD, AGAF,FACG, FACP University of Michigan – Ann ArborDirector of the DigestiveDiseases CenterCo-Author of ACG GuidelinesANTHONY LEMBO, MD Harvard – Beth Israel DeaconessMedical CenterTISHA LUNSFORD, MD Mayo ClinicDirector of the Motility Interest GroupBRIAN LACY, MD, PHD Mayo ClinicCurrent co-Editor in Chief of theAmerican Journal of GastroenterologyCo-Author of ACG GuidelinesEAMONN QUIGLEY, MD Chief, Division of Gastroenterology andHepatology at Houston MethodistBROOKS CASH, MD, AGAF, FACG,FACP, FASGE Chief of Gastroenterology, University ofTexas Health Science Center at HoustonCopyright 2021 Biomerica. All Rights Reserved5
Background & InnovationLeveraging diagnostic expertise to transition into diagnostic-guided therapeuticsSpecialty diagnostics enabling earlydisease detection and monitoringTwo FDA, CE, CFDA registered manufacturingfacilities in California and MexicoCommercially launched FDA cleareddiagnostic testsDisruptive patented technology platformenabling diagnostic therapiesRedefining the treatment of GI diseasesAlso applicable for treating non-GI chronicinflammatory diseasesGross margin opportunities similar to drugsCopyright 2021 Biomerica. All Rights Reserved6
InFoods – Diagnostic Guided Therapy (DGT)to Treat Chronic Inflammatory DiseasesExample of Patient-Specific ResultsFDA-regulated diagnostic to be used as therapyMeasures immunoreactivity for a panel of foods to determine which foods are abovenormal range and problematic for a specific patientAllows physicians to identify patient-specific foods which, when removedfrom diet, may alleviate or improve the patient’s gastrointestinal symptomsand sufferingClinical trial guided by U.S. members of the Rome Foundation, theleading organization that sets IBS treatment guidelinesFoodResultBlueberry POSITIVEChickenNEGATIVECabbageNEGATIVEEgg Pork POSITIVEPotatoNEGATIVESugarNEGATIVEPositive for: egg, blueberry, and porkNote: Clinical lab product in clinical studies. Point of care product under developmentCopyright 2021 Biomerica. All Rights Reserved7
Irritable BowelSyndrome (IBS)is Very Commonand CostlyIBS is the #1 most commondiagnosis made bygastroenterologists1IBS is the #7 most commondiagnosis made byall physicians1IBS patients visit doctors 3xmore than non-IBS patientsIBS sufferers have 74% moredirect healthcare costs vs.non-IBS sufferersThe Majority of IBS patients believe foods trigger their symptoms1RecentAGA Survey (American Gastroenterological Association).Copyright 2021 Biomerica. All Rights Reserved8
IBS Market isSignificant Todayand GrowingMD 30B C40MillionIBS Patients in the USU.S. TAM11/3 IBS-C(Constipation) 12M I L L I O N1GlobalUS IBS Patients:seeking consistentphysician treatment 13M I L L I O N1/3 IBS-D(Diarrhea)1/3 IBS-M (Mixed:Alternates C D)IBS-M Patients:No approvedtherapy/drug2prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clinical gastroenterology and hepatology. 2012 Jul 1;10(7):712-21.bowel syndrome in the United States: prevalence, symptom patterns and impact. Alimentary pharmacology & therapeutics. 2005 Jun;21(11):1365-75.2IrritableCopyright 2021 Biomerica. All Rights Reserved9
InFoods IBS: Broad Benefits to Patients,Physicians, and Healthcare InsurersTargets 100% of the IBS Market (IBS-M, IBS-C, IBS-D)11IBS-MPatient BenefitsPhysician BenefitsPayer/insurer BenefitsInFoods targets underlyingcauses without causing sideeffectsInFoods : Recurring revenuepotential as problem foodschange in patientsInFoods insurer savingsCurrently: IBS Patients require 3xdoctor visits & monthly drug costsVSVSIBS Drugs – Primarily treatsymptoms AND can causemajor side effectsIBS Drugs 0 revenue tophysicianU.S. Healthcare annual costs ofIBS 30B/year Mixed: Alternates C D; IBS-C Constipation; IBS-D Diarrhea.Copyright 2021 Biomerica. All Rights Reserved10
FDA Approved Therapies are Expensive andhave Efficacy and Safety esponsePlaceboResponseDrug minusPlaceboResponseMonthlyCostAnnualizedU.S. SaleLimitationsLinzess201220% - 34%6% - 27%7% - 14% 467 1,963M Diarrhea sideeffect (20%)Amitiza200814%8%6% 371 410M Indicated for womenonly; not studiedfor menXifaxan201541%32%9% 2,7571 1,905M Not for chronic useViberzi201525% - 30%17% - 16%8% - 14% 1,383 266M Abdominal pain(secondary) endpointnot metLotronex2002NANA13% - 20% 2,2402 6M For women only Black box warningIBS-CIBS-DIBS Drug Side EffectsCan Be Dangerous1DenotesLotronex carries a black box warning related to the risk of potentially serious GI eventscost for 550mg Xifaxan dose; 200mg dose WAC is 723.Source: IQVIA FY2020 sales and monthly WAC.2Denotescost for 1mg Lotronex dose; 0.5mg dose WAC is 1,120.Copyright 2021 Biomerica. All Rights Reserved11
Biomerica First-GenerationProduct vs. Lotronex (Diarrhea Stool Frequency: an FDA endpoint)IBS-DiarrheaStool Frequency(% change from baseline)AlosetronFood IgG120%Alosetron (Lotronex )Drop from Baseline:100%80%30%60%40%Biomerica First-Gen ProductDrop from Baseline:20%65%0%02468101214WeekSeparate Independent studies: Ther Adv Gastroenterol 2018, Vol. 11: 1–11 J Int Med Res. 2012;40(1):204-10.Copyright 2021 Biomerica. All Rights Reserved12
InFoods Regulatory PathwayIP & DataProduct Dev. R&DFDA Sub QEnd Point TrialPivotal Trial12 – 14 months1. final patient treatment2. Top line resultsFDA has indicated InFoods IBS willbe evaluated as a therapyFDA ApprovalFDA has determined proposed IBSclinical study is a non-significantrisk avoids much costlier and moretime-consuming PMA clinical trialroute (No Phase I,II orIII required)Ongoing Endpoint Trial is currentlyenrolling patients with dual goals ofidentifying the best primaryendpoint to use in the final PivotalTrial and further validating theplatform with interim dataEndpoint and Pivotal Trials OverviewSitesDesignPrimary EndpointParticipantsMayo Clinic, HarvardBID, University ofMichigan, HoustonMethodist, University ofTexas HoustonDouble-blind randomizedcontrolled trial of true dietfor foods with a positiveimmune response v. shamdiet of random foodsAll 9 FDA endpoints QOL,API, BSS, SSS, etc. forEndpoint Trial; oneendpoint to be selected forPivotal Trial (e.g. API)N 180 (Endpoint Trial);N 500-700 (Expected forPivotal Trial)EstimatedCompletionFinal patient treatmentcompleted & top lineresults in January 2022;12-14 months frominitiation for Pivotal TrialCopyright 2021 Biomerica. All Rights Reserved13
InFoods Commercialization StrategyMultiple Avenues to Drive AdoptionInclusion in GuidelinesInclusion in the IBS treatmentguidelines will accelerate productadoptionThe Rome Foundation holdssignificant influence in setting thetreatment guidelinesReimbursement Awarenessand Enhanced CoverageHelp GI physicians monetize theirlargest patient population:reimbursement code alreadyexists for Medicare patientsInitiate conversations with payorsto enhance accessto product at both the pointof care and outpatient diagnosticcentersBroad Physician InterestCapitalize on strong physicianinterest evidenced by marketresearch1GI physician and PCPrespondents indicated they wouldadopt this product for 95% 100% of their patients, dependingon the IBS subtype195% GI Physicians and PCPs Would Adopt InFoods for Their Patients Depending on Subtype1MarketResearch Source: Market Vision. Percentages shown represent medians for both GI physicians and PCPs based on the information they were presented as part of the market research survey.Copyright 2021 Biomerica. All Rights Reserved14
SAB: Rome FoundationSets IBS GuidelinesExpertise in Clinical TrialsRome Foundation(Leading IBS organization)Leading independent nonprofit organization focusedon the diagnosis andtreatment of functionalgastrointestinal disorders,including IBSRome creates the diagnosticcriteria and guidelines thatFDA and physicians use todefine an IBS patient, andtreat those patientsDr. Doug Drossman(Biomerica SAB Chair)Key Expertise onIBS Clinical TrialsDr. Doug Drossman(President Emeritus of theRome Foundation) is one ofthe foremost opinion leadersin IBSSAB members were the PI’son clinical trials for multipleapproved GI drugs,including Linzess , Viberzi ,and Xifaxan Members serve on FDA GIadvisory panelParticipated in 50 ClinicalStudies for IBSCopyright 2021 Biomerica. All Rights Reserved15
PlatformTechnology:InFoods Development PipelineIP & DataFunctionalGastrointestinalDisordersProductDev. R&DFDA Sub QEndPoint TrialPivotalTrialFDAApprovalIrritable Bowel Syndrome (IBS)Functional DyspepsiaGERD diseaseGastrointestinalDiseasesUlcerative Colitis (UC)Other arthritisDepressionCopyright 2021 Biomerica. All Rights Reserved16
SpecialtyDiagnosticsCopyright 2021 Biomerica. All Rights Reserved17
2022 Growth opportunity - H. pyloriStatus: Biomerica is targeting to have its H. pylori clinical studies completed, and FDA 510Ksubmission filed by end of March, 2022. Initial sales planned in summer 2022.Detects H. pylori AntigenGastric Cancer: Gastric cancer is the 3rd most common cause of cancer related death inH. pylori is a bacteria thatinfects approximately 35% ofthe U.S. population and 45% ofthe population in the five majorcountries in the Europe.Approximately 20% of H. Pyloriinfected patients develop arange of issues including pepticulcer disease, dyspepsia andgastric cancer.the world. Over 80% of gastric cancers are attributed to H. pylori infection. In 2017,the World Health Organization (WHO) listed H. pylori among the 16 antibiotic-resistant bacteriathat pose the greatest threat to human health and designated H. pylori as aClass 1 carcinogen.Profit Opportunity: Once approved by the FDA, Biomerica could sell its H. pylori productat a significant discount to competitive products and still earn 80% gross margin.Customers: The majority of H. pylori diagnostic tests are sold to large labs such as Quest,LabCorp and ARUP. Therefore, less marketing effort is needed to achieve material marketpenetration.Copyright 2021 Biomerica. All Rights Reserved18
Colorectal Disease Test: EZ Detect EZ Detect is a 2-minute, at-home test forthe determination of fecal occult blood, anearly warning sign of colorectal cancer(CRC) and other colorectal diseases.12Quick & Simple:No Stool Handling3InterpretationNegativePositivePositiveAny color in the test area (no matter how small) should be considered as a positive resultCopyright 2021 Biomerica. All Rights Reserved19
Key performance metrics for EZDetectTM, Cologuard , & FITsValuePriceEZ Detect (1) Cologuard (2)FIT(2) 14 649 2293.2%86.6%94.7%Positive Likelihood Ratio91.26.914.3Negative Likelihood Negative Predictive Value92.5% (124/134)99.9% (7936/7941)99.8%(8695/8712)Positive Predictive Value96.4% (27/28)4.6% (60/1291)9.2% (48/520)AccuracySpecificity (vs. all negative findingson colonoscopy/sigmoidoscopy)Sensitivity (vs. all CRC found bycolonoscopy/sigmoidoscopy)(1)Resultsof the Study (Screening) Conducted by Renfe's Medical Department. 2000.Stool DNA Testing for Colorectal-Cancer Screening. Imperiale, Thomas F, et al. 2014, The New England Journal of Medicine, Vol. 370, pp. 1287-1297.(2)MultitargetCopyright 2021 Biomerica. All Rights Reserved20
EZ Detect :Available at WalmartNow in over4,600Walmart StoresCopyright 2021 Biomerica. All Rights Reserved21
Disruptive Patented Platform Technologyredefining the GI MarketAddressing the large need for IBS patients and then targetingmultiple other diseasesInFoods Model is UniqueLeveragingOur UniqueTechnologyBenefits Patient / Physician / InsurerBroad IP ProtectionRobust patent portfolio (9 issued patents; 100 patents pending) 16 year remaining on patents filed Patents cover multiple disease statesFinancially Attractive Low burn rate Clean Cap table - No warrants, no preferred equity and no debtIBS Key Opinion Leaders set Treatment Guidelines SAB Leadership includes US Members of the Rome Foundation Clinical studies lead by principal investigators whoset GI “treatment guidelines”Copyright 2021 Biomerica. All Rights Reserved22
Mayo Clinic, Harvard BID, University of Michigan, Houston Methodist, University of Texas Houston Sites Double-blind randomized controlled trial of true diet for foods with a positive immune response v. sham diet of random foods Design All 9 FDA endpoints QOL, API, BSS, SSS,
