Chembio Diagnostics
Annual Report 2018

Plain-text annual report

UNITED STATESSecurities and Exchange CommissionWashington, D.C. 20549 FORM 10-K [X]ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2018 or [ ]TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from_______ to ______. Commission File No. 0-30379 CHEMBIO DIAGNOSTICS, INC.(Exact name of registrant as specified in its charter) Nevada 88-0425691(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 3661 Horseblock Road, Medford, NY 11763(Address of principal executive offices) (Zip Code)Registrant’s telephone number, including area code (631) 924-1135 Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of each exchange on which registeredCommon Stock, $0.01 par value The NASDAQ Stock Market LLCSecurities registered pursuant to Section 12(g) of the Act:None(Title of Class)Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes __ No XIndicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes __ No XIndicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filingrequirements for the past 90 days. Yes X No__Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 ofRegulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit suchfiles). Yes X No __Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and willnot be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K orany amendment to this Form 10-K. [X]Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or anemerging growth company. See the definitions of "large accelerated filer", "accelerated filer", "smaller reporting company," and "emerging growth company"in Rule 12b-2 of the Exchange Act.Large accelerated filer [ ]Accelerated filer [X ]Non-accelerated filer [ ]Smaller reporting company [X ]Emerging growth company [ ]If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new orrevised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act [ ]Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes __ No XAs of the last business day of the registrant's most recently completed second fiscal quarter, the aggregate market value of voting and non-voting commonequity held by non-affiliates was $154,594,062.As of March 1, 2019, the registrant had 17,166,459 shares of common stock outstanding.Documents Incorporated By ReferencePortions of the registrant’s proxy statement for its 2019 annual meeting of stockholders are incorporated by reference in Part III of this report.TABLE OF CONTENTS PagePART I ITEM 1.BUSINESS3ITEM 1A.RISK FACTORS9ITEM 2.PROPERTIES21ITEM 3.LEGAL PROCEEDINGS21PART II ITEM 5.MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUERPURCHASES OF EQUITY SECURITIES22ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS23ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA28ITEM 9A.CONTROLS AND PROCEDURES28PART III ITEM 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE30ITEM 11.EXECUTIVE COMPENSATION30ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATEDSTOCKHOLDER MATTERS30ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE30ITEM 14.PRINCIPAL ACCOUNTANT FEES AND SERVICES30PART IV ITEM 15.EXHIBITS, FINANCIAL STATEMENT SCHEDULES31SIGNATURES 32Unless the context requires otherwise, the words “our,” “our company,” “us,” “we” and similar terms refer to Chembio Diagnostics, Inc. and its consolidatedsubsidiaries.DPP, SAMPLETAINER, STAT-PAK, STAT-VIEW and SURE CHECK are our registered trademarks. For convenience, these trademarks appear in thisprospectus supplement without ® symbols, but that practice does not mean that we will not assert, to the fullest extent under applicable law, our rights to thetrademarks. This report also includes trademarks and service marks owned by other organizations.FORWARD-LOOKING STATEMENTS AND STATISTICAL ESTIMATESThis report contains statements reflecting our views about our future performance that constitute “forward-looking statements” within the meaning of thePrivate Securities Litigation Reform Act of 1995. These forward-looking statements are generally identified through the inclusion of words such as“anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “objective,” “outlook,” “plan,” “potential,”“project,” “seek,” “should,” “strategy,” “target,” “will,” “would” or variations of such words or similar expressions. All statements addressing our futureoperating performance, and statements addressing events and developments that we expect or anticipate will occur in the future, are forward-lookingstatements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based upon currently availableinformation, operating plans, and projections about future events and trends.This report contains estimates, projections and other data concerning our industry, our business, and the markets for our products. Where expressly stated,we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by World Health Organization,or WHO. We also include data that we have compiled, obtained, identified or otherwise derived from reports, research surveys, studies and similar dataprepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. Other thanWHO, we do not expressly refer to the sources from which this data is derived.Forward-looking statements and statistical estimates inherently involve risks and uncertainties that could cause actual results to differ materially fromthose predicted or expressed in this report. These risks and uncertainties include those described below in “Item 1A. Risk Factors.” Investors are cautionednot to place undue reliance on any forward-looking statements or statistical estimates, which speak only as of the date they are made. We undertake noobligation to update any forward-looking statement or statistical estimate, whether as a result of new information, future events or otherwise.2 Table of ContentsPART IITEM 1.BUSINESSOverviewWe are a leading provider of point-of-care diagnostic products for the detection and diagnosis of infectious diseases. We have been expanding our productportfolio based upon our proprietary Dual Path Platform, which we refer to as the DPP technology platform, which uses a small drop of blood from thefingertip to provide high-quality, cost-effective diagnostic results in approximately 15 minutes. We seek to build additional revenue streams by entering intotechnology collaborations with leading global healthcare companies to leverage the DPP platform.Compared with traditional lateral flow technology, the DPP technology platform provides enhanced sensitivity and specificity, advanced multiplexingcapabilities, and, when used with the DPP Micro Reader, quantitative results. Our DPP test for human immunodeficiency virus, or HIV, provides sensitivity of99.8% and specificity of 100%, and has been approved by the U.S. Food and Drug Administration, or FDA, and cleared as a waived test under the ClinicalLaboratory Improvement Amendments of 1988, or CLIA. On November 6, 2018, we completed our acquisition of opTricon GmbH, a Berlin-based developerand manufacturer of handheld analyzers for rapid diagnostic tests, which we believe will enable us to promote DPP tests and DPP Micro Readers moreactively across global markets.We are pursuing three corporate priorities, the key building blocks to drive growth and operating efficiency: (1) expand our commercialization; (2) advanceour research and development pipeline; and (3) prepare for future growth.IndustryThe DPP technology platform addresses the lateral flow test market, which includes infectious diseases, cardiac markers, cholesterol and lipids, pregnancyand fertility, and drugs of abuse. Based on our review of third-party reports and other information, we estimate that the market for lateral flow tests willincrease from $5.5 billion in 2017 to $8.2 billion in 2022, representing a compound annual growth rate of 8.2%.Infectious disease tests constitute the largest, and fastest growing, segment of the lateral flow test market. We currently are targeting lateral flow test solutionsfor three areas of infectious diseases: sexually transmitted disease, mosquito-borne disease and hepatitis. The market for lateral flow infectious disease tests isbeing driven by the high prevalence of infectious diseases globally, an increase in the geriatric population, growing demand for rapid test results, andadvancements in multiplexing. Based on our review of third-party reports and other information, we estimate that the market for lateral flow infectiousdisease tests will increase from $1.4 billion in 2017 to $2.3 billion in 2022, representing a compound annual growth rate of 10.7%.ProductsOur point-of-care infectious disease portfolio is comprised of multiple commercial products, each serving unique customer requirements. The key advantagesof our products, which are performed with a tiny drop of blood from the fingertip and provide results in approximately 15 minutes, include:• enhanced sensitivity and specificity;• advanced multiplexing; and• quantitative results, when used with DPP Micro Reader.We have obtained U.S. FDA approvals and, directly or through our partners, international regulatory approvals for infectious disease tests as follows:Product (Assay)U.S.InternationalDPP HIV 1/2 ✓✓✓✓DPP HIV-Syphilis ✓✓DPP Syphilis Screen & Confirm ✓✓DPP Zika ✓✓✓✓DPP Leishmaniasis ✓✓STAT-PAK HIV 1/2 ✓✓✓✓STAT-PAK Chagas ✓✓SURE CHECK HIV 1/2 ✓✓✓✓SURE CHECK HIV 1/2 Self Test ✓✓Organic growth in our core infectious disease business is being driven by:• growth in the overall market for lateral flow infectious disease tests, which we estimate will increase at a compound annual growth rate of 10.7%through 2022 (see “--Industry” above);• our increased market penetration in existing markets and channels, including in the United States, Latin America, Africa and Europe;• our registration of existing and new products in unchartered countries and regions, such as selected countries in Latin America and Southeast Asia;• our entry into new market segments, such as international HIV Self-Testing; and• advances in our product pipeline in infectious disease with key products including a multiplex test for HIV and syphilis in the U.S. market and testsfor dengue, zika and chikungunya.We market and sell both stand-alone and multiplex tests for sexually transmitted infectious diseases, such as HIV and syphilis. HIV and syphilis continue tobe major global public health issues. According to WHO estimates:• HIV has claimed more than 35 million lives, including 940,000 in 2017. Approximately 36.9 million were living with HIV at the end of 2017, and1.8 million were newly infected during 2017.• There were 18.0 million prevalent cases of syphilis as of 2012, and 5.6 million new infections were estimated to occur annually.• Elimination of mother-to-child transmission, or MTCT, of both HIV and syphilis is a global health priority. In 2013, 1.9 million pregnant womenwere infected with syphilis worldwide. Congenital syphilis contributes significantly to infant mortality, accounting for 305,000 annual perinataldeaths worldwide in 2013. Globally, more than 1.4 million pregnant women were infected with HIV as of 2015, and MTCT of HIV is estimated tohave resulted in over 150,000 infant cases in 2015.We are seeking to address the global concerns related to HIV and syphilis co-infection through the development of a novel, multiplex test for both HIV andsyphilis. We have developed a DPP HIV-Syphilis multiplex test and received regulatory approvals covering a number of international markets, includingBrazil, Europe, Malaysia and Mexico. In the United States we have completed a DPP HIV-Syphilis clinical trial and filed a Pre-Market Approval Applicationwith the FDA, which is in the review process. We believe we are well-positioned to be the first company to introduce a multiplex rapid test for HIV andsyphilis in the United States.We also market and sell tests for selected fever and tropical diseases such as Chagas, ebola, leishmaniasis and Zika. The market for lateral flow mosquito-borne diseases includes established markets for disease such as dengue and malaria, which WHO estimates together account for more than 600 million annualinfections worldwide. There are also a number of emerging markets for lateral flow tests for infectious diseases such as burkholderia, chikungunya, lassa,leptospirosis, Marburg, rickettsia and Zika. We are developing tests, using the DPP platform, to detect all of the aforementioned fever and tropical diseases, asstand-alone or multiplex tests.Since 2015 we have received over $9 million of funding from some of the world’s leading health organizations, which has helped us accelerate the expansionof our pipeline of infectious disease tests. Our collaborators have included Bill & Melinda Gates Foundation, The Paul G. Allen Family Foundation, TheOswaldo Cruz Foundation or FIOCRUZ, and the Foundation for Innovative New Diagnostics or FIND, as well as U.S. government agencies such as Centers forDisease Control, or CDC, and the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services orBARDA, and the U.S. Department of Agriculture, or USDA. Many of the tests in our infectious disease pipeline are approaching commercialization, andseveral have received initial regulatory approvals:ProductCollaboratorPhase I FeasibilityPhase II DevelopmentPhase IIIVerification&ValidationPhase IVClinical/RegulatoryPhase VCommercialLaunchDPP HIV-Syphilis (US) Self-funded✓✓✓✓✓✓Submitted FDAQ1 2018 DPP Dengue (International)Fiocruz✓✓✓✓✓✓Submitted ANVISA1Q3 2018 DPP Dengue NS1 (International)Fiocruz✓✓✓✓Ongoing DPP Zika (US/International)Fiocruz✓✓✓✓✓✓✓ReceivedFDA EUA2,ANVISA, CE markDPP Chikungunya (International)Fiocruz✓✓✓✓✓✓✓ReceivedANVISA, MalaysiaDPP Dengue-Zika-Chikungunya(International)Fiocruz✓✓✓✓✓✓Submitted ANVISAQ3 2018ReceivedMalaysiaDPP Malaria (International)Bill & MelindaGates Foundation✓✓✓✓Ongoing DPP Ebola (US, International)Centers for DiseaseControl✓✓✓✓✓✓Received FDA EUAQ4 2018 DPP Fever Panel (Africa) The Paul G. AllenFamily Foundation✓✓✓✓✓✓Field Testing:Africa, South America DPP Fever Panel (Asia) FIND✓✓Ongoing ____________________________1 Agência Nacional de Vigilância Sanitária (Brazil)2 Emergency Use AuthorizationCollaborationsWe are building additional revenue streams by leveraging our patented DPP technology and scientific expertise through collaborations. Leading globalhealthcare organizations have chosen to collaborate with us based on our deep scientific expertise with our proven DPP technology platform and capabilities,our successful record of developing DPP tests with a diverse set of collaborators including global commercial companies, governments and non-governmental organizations, and our extensive experience in obtaining regulatory approvals in the United States (FDA), Brazil (ANVISA), the EuropeanUnion (CE mark) and Mexico (Comisión Federal para la Protección contra Riesgos Sanitarios, or COFEPRIS) as well as from WHO (Prequalification, or PQ).ProductCollaboratorPhase I FeasibilityPhase II DevelopmentPhase IIIVerification&ValidationPhase IVClinical/RegulatoryPhase VCommercialLaunchDPP Eosinophilic / RespiratoryAstraZeneca✓✓✓✓Ongoing Received CE markQ4 2018 DPP Cancer Undisclosed✓✓✓✓Ongoing Infectious Disease PortfolioLumiraDxInitiated Q32018 DPP Concussion Perseus Science✓✓Ongoing DPP Bovine Tuberculosis USDA✓✓Ongoing DPP Hepatitis C Ab FIND✓✓Ongoing DPP Hepatitis C Ag FINDInitiated Q32018 By leveraging our DPP technology platform, we are creating opportunities to expand into new markets such as cancer diagnostics, concussion and traumaticbrain injury, and veterinary and we are broadening the application of our technology from point-of-care diagnostics to include companion diagnostics.Research and development costs related to the collaborations are fully funded by our collaborators.Sales ChannelsOur products are sold globally, both directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public healthorganizations, government agencies and consumers. Historically we marketed and sold our products only into a handful of countries and regions. In recentyears we have hired sales executives to begin building our own channels in key markets such as the United States, Europe, Latin America, Africa andSoutheast Asia. With sales growth as an underlying objective, we are focused on increasing sales in existing geographies, expanding sales into newgeographies, and broadening sales coverage in key markets.Automation of U.S. ManufacturingWe are automating our U.S. manufacturing processes and expanding our manufacturing capacity. During 2018, we took delivery of our first automatedmanufacturing line. This automated manufacturing line will be used for DPP test production and will allow assembly of various configurations of DPP testson the line. The automated line will have an annual capacity of between five and ten million tests, depending on the test configuration, and will use vision-guided, robotic operation to improve inspection and quality control. As we transition from manual to automated assembly, we believe the reduced variablecosts will improve product gross margins.3 Table of ContentsDPP Technology & DevelopmentOur commercially available products employ either our patented DPP technology or traditional lateral flow technology. We believe products developedusing our DPP technology can provide superior diagnostic performance compared with products that utilize traditional lateral flow technology. We are executing our strategy to leverage DPP intellectual property, as well as our scientific and operational expertise, to create new collaborations where wewill serve as an exclusive development and manufacturing partner. Examples of such collaborations include the following:• In January 2015, we entered into an agreement with the Concussion Science Group (CSG) Division of Perseus Science Group LLC to develop apoint-of-care diagnostic test for traumatic brain injury, including sports-related concussions, utilizing both our DPP and optical analyzertechnologies.• In October 2017, we signed a development agreement with AstraZeneca for the development of a quantitative point-of-care test for eosinophilicrespiratory disease, utilizing both our DPP and optical analyzer technologies.• In April 2018, we entered into a collaboration agreement with LumiraDx to develop new point-of-care diagnostic tests for infectious diseases. Underterms of the agreement, we receive funding from LumiraDx, subject to satisfying certain milestones, to develop certain new point-of-care infectiousdisease tests. Following the regulatory approval and commercialization of tests in accordance with this agreement, Chembio will both sell reagentsto, and receive royalty payments from, LumiraDx on sales of all products developed through this collaboration.• In November 2018, we acquired opTricon (Berlin, Germany), a leading developer of handheld optical analyzers rapid diagnostic tests. See“Management’s Discussion & Analysis of Financial Condition and Results of Operations—Recent Developments.”CompetitionMany of our competitors are significantly larger and have greater financial, research, manufacturing, and marketing resources. Important competitive factorsinclude product quality, analytical performance, ease of use, price, customer service and reputation. Industry competition is based on these and the followingadditional factors:• patent protection;• scientific expertise;• ability to develop and market products and processes;• ability to obtain required regulatory approvals;• ability to manufacture cost-effective products that meet applicable regulatory requirements;• access to adequate capital; and,• ability to attract and retain qualified personnel.4 Table of ContentsWe believe our scientific capabilities and proprietary know-how relating to our patented DPP technology and lateral flow technology are very strong,particularly for the development and manufacture of tests for the detection of antibodies to infectious diseases, and other diseases.Our ability to develop and market other products is in large measure dependent on our having additional resources and/or collaborative relationships. Someof our product development efforts have been funded on a project or milestone basis. We believe that our proprietary know-how relating to our patented DPPtechnology has been instrumental in our obtaining the collaborations we have and that we continue to pursue. We believe that our patent protectionenhances our ability to both develop more profitable, collaborative relationships and expand licensing revenue. However, there are a number of competitivetechnologies used and/or seeking to be used by others in point-of-care settings.Although we have no specific knowledge of any other competitors’ products that could render our products obsolete, if we fail to maintain and enhance ourcompetitive position or fail to introduce new products and product features, our customers may decide to use the products developed by our competitors,which could result in a loss of revenues and cash flow. EmployeesAs of December 31, 2018, we had 295 full-time equivalent employees, of whom 15 were in administration, 215 were in manufacturing, 45 were in researchand development, and 20 were in sales and marketing and customer service. Of these employees, approximately 240 were located in the United States, 27 were located in Malaysia, 20 were located in Germany, and 3 were located in other countries.We have never had a work stoppage, and none of our employees are represented by a labor organization or subject to any collective bargaining arrangements.We consider our employee relations to be good.Governmental RegulationCertain of our activities are subject to regulatory oversight by the FDA under provisions of the Federal Food, Drug, and Cosmetic Act and regulationsthereunder, including regulations governing the development, marketing, labeling, promotion, manufacturing, and export of diagnostic products. Ourclinical laboratory customers are subject to oversight by Centers for Medicare and Medicaid Services, or CMS, pursuant to CLIA, as well as agencies invarious states. Failure to comply with applicable requirements can lead to sanctions, including withdrawal of products from the market, recalls, refusal toauthorize government contracts, product seizures, civil money penalties, injunctions, and criminal prosecution.FDA Approval/Clearance RequirementsUnless an exemption applies, each medical device that we market or wish to market in the United States must receive 510(k) clearance or PremarketApproval, or PMA. Medical devices that receive 510(k) clearance are “cleared” by the FDA to market, distribute, and sell in the United States. Medicaldevices that obtain a PMA by the FDA are “approved” to market, distribute and sell in the United States. We cannot be certain that 510(k) clearance or PMAapproval will ever be obtained for any products that have not already obtained 510(k) clearance or PMA approval. Descriptions of the PMA and 510(k)clearance processes are provided below.The FDA decides whether a device line must undergo either the 510(k) clearance or PMA based on statutory criteria that utilize a risk-based classificationsystem. PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices and, in many cases,Class II medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of humanhealth, or which present a potential, unreasonable risk of illness or injury. The FDA uses these criteria to decide whether a PMA or a 510(k) is appropriate,including the level of risk that the agency perceives is associated with the device and a determination by the agency of whether the product is a type ofdevice that is similar to devices that are already legally marketed. Devices deemed to pose relatively less risk are placed in either Class I or II. In many cases,the FDA requires the manufacturer to submit a 510(k) requesting clearance (also referred to as a premarket notification), unless an exemption applies. The510(k) must demonstrate that the manufacturer’s proposed device is “substantially equivalent” in intended use and in safety and effectiveness to a legallymarketed predicate device. A “predicate device” is a pre-existing medical device to which equivalence can be drawn, that is either in Class I or Class II or is aClass III device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for submission of a PMA application.Device classification depends on the device’s intended use and its indications for use. In addition, classification is risk-based, that is, the risk the deviceposes to the patient and/or the user is a major factor in determining the class to which it is assigned. Class I includes devices with the lowest risk and Class IIIincludes those with the greatest risk.Class I devices are those for which safety and effectiveness can be assured by adherence to the FDA’s general regulatory controls for medical devices, or theGeneral Controls, which include compliance with the applicable portions of the FDA’s quality system regulations, facility registration and product listing,reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials. Some Class I devicesalso require premarket clearance by the FDA through the 510(k) process described below.Class II devices are subject to the FDA’s General Controls, and any other special controls as deemed necessary by the FDA to ensure the safety andeffectiveness of the device. Premarket review and clearance by the FDA for Class II devices is accomplished through the 510(k) process. Pursuant to theMedical Device User Fee and Modernization Act of 2002, unless a specific exemption applies, 510(k) submissions are subject to user fees. Certain Class IIdevices are exempt from this premarket review process.Class III includes devices with the greatest risk. Devices in this class must meet all of the requirements in Classes I and II. In addition, Class III devicescannot be marketed until they receive Premarket Approval.The safety and effectiveness of Class III devices cannot be assured solely by the General Controls and the other requirements described above. These devicesrequire formal clinical studies to demonstrate safety and effectiveness. Under Medical Device User Fee and Modernization Act of 2002, PMA applications(and supplemental premarket approval applications) are subject to significantly higher user fees than 510(k) applications, and they also require considerablymore time and resources.Rapid HIV tests intended for diagnostic use are regulated as Class III devices. Responsibility for assuring the safety and effectiveness of these tests lieswithin the Center for Biologics Evaluation and Research’s Office of Blood Research and Review, with oversight by the Blood Products AdvisoryCommittee. Approved rapid HIV tests must meet the regulations in the 21 CFR 800 series subparts, under the investigational device exemption, or IDE andPMA pathways.5 Table of ContentsPremarket Approval PathwayWe manufacture, market and distribute three rapid HIV tests in the United States. Our HIV 1/2 STAT-PAK Assay, SURE CHECK HIV 1/2 Assay, and DPP HIV1/2 Assay all have received FDA PMA approval. A PMA application must be supported by extensive data including, but not limited to, analytical,preclinical, clinical trials, manufacturing, statutory preapproval inspections, and labeling to demonstrate to the FDA’s satisfaction the safety andeffectiveness of the device for its intended use. Before a PMA is submitted, a manufacturer must apply for an IDE. If the device presents a “significant risk,”as defined by the FDA, to human health, the FDA requires the device sponsor to file an IDE application with the FDA and obtain IDE approval prior toinitiation of enrollment of human subjects for clinical trials. The IDE provides the manufacturer with a legal pathway to perform clinical trials on humansubjects where without the IDE, only approved medical devices may be used on human subjects. The IDE application must be supported by appropriate data, such as analytical, animal and laboratory testing results, manufacturing information, and anInvestigational Review Board (IRB) approved protocol showing that it is safe to test the device in humans and that the testing protocol is scientificallysound. If the clinical trial design is deemed to have “non-significant risk,” the clinical trial may be eligible for “abbreviated” IDE requirements. In someinstances, clinical trials for in vitro diagnostic medical devices may be exempt from the more burdensome IDE requirements if certain labeling requirementsare met.A clinical trial may be suspended by either the FDA or the Investigational Review Board at any time for various reasons, including a belief that the risks tothe study participants outweigh the benefits of participation in the study. Even if a study is completed, clinical testing results may not demonstrate the safetyand efficacy of the device, or they may be equivocal or otherwise insufficient to obtain approval of the product being tested. After the clinical trials havebeen completed, if at all, and the clinical trial data and results are collected and organized, a manufacturer may complete a PMA application.After a PMA application is sufficiently complete, the FDA will accept the application and begin an in-depth review of the submitted information. By statute,the FDA has 180 days to review the “accepted application,” although, generally, review of the application can take between one and three years, but it maytake significantly longer. During this review period, the FDA may request additional information or clarification of information already provided. Also,during the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and providerecommendations to the FDA as to the approvability of the device. The preapproval inspections conducted by the FDA include an evaluation of themanufacturing facility to ensure compliance with the FDA's quality systems regulations or QSR, as well as inspections of the clinical trial sites by theBioresearch Monitoring group to evaluate compliance with good clinical practice and human subject protections. New PMA applications or PMAsupplements are required for modifications that affect the safety or effectiveness of the device, including, for example, certain types of modifications to thedevice’s indication for use, manufacturing process, labeling and design. Significant changes to an approved PMA require a 180-day supplement, whereasless substantive changes may utilize a 30-day notice, or a 135-day supplement. Premarket approval supplements often require submission of the same type ofinformation as a premarket approval application, except that the supplement is limited to information needed to support any changes from the devicecovered by the original premarket approval application, and it may not require as extensive clinical data or the convening of an advisory panel.Our HIV 1/2 STAT-PAK Assay PMA application number BP050009/0 and our SURE CHECK 1/2 HIV Assay PMA application number BP050010/0 wereapproved by the FDA in May 2006. Our DPP HIV 1/2 Assay PMA application number BP120032/0 was approved by the FDA in December 2012.510(k) Clearance PathwayWe are currently developing products that either will or are likely to require an FDA 510(k) clearance, and we anticipate submitting a 510(k) for each suchproduct to demonstrate that such proposed device is substantially equivalent to a respective previously cleared 510(k) device or a device that was incommercial distribution before May 28, 1976, for which the FDA has not yet called for the submission of 510(k). FDA's 510(k) clearance pathway usuallytakes from three to twelve months but could take longer. In some cases the FDA may require additional information, including clinical data, to make adetermination regarding substantial equivalence.If a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a new or majorchange in its intended use, will require a new 510(k) clearance or, depending on the modification, a PMA. The FDA requires each device manufacturer todetermine whether the proposed change requires submission of a new 510(k) or a PMA, but the FDA can review any such decision and can disagree with amanufacturer’s determination. If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/orrecall the modified device until 510(k) clearance or PMA of the modified device is obtained.If the FDA requires us to submit a new 510(k) or PMA for any modifications to a previously cleared product, or if we obtain 510(k) clearance for a device inthe future, we may be required to submit a separate new 510(k) or PMA application for such modifications.Clinical Laboratory Improvement Amendments of 1988A manufacturer of a test categorized as moderately complex may request that categorization of the test be waived through a CLIA Waiver by Application, orCW, submission to the FDA. When a test is categorized as waived, it may be performed by laboratories with a Certificate of Waiver, such as a physician’soffice outreach setting. In a CW submission, the manufacturer provides evidence to the FDA that a test meets the CLIA statutory criteria for waiver CLIA, awalk-in clinic or an emergency room provides CMS authority over all laboratory testing, except research that is performed on humans in the United States.The Division of Laboratory Services, within the Survey and Certification Group under the CMS, has the responsibility for implementing the CLIA program.The CLIA program is designed to establish quality laboratory testing by ensuring the accuracy, reliability and timeliness of patient test results. Under CLIA,a laboratory is a facility that does laboratory testing on specimens derived from humans and used to provide information for the diagnosis, prevention ortreatment of disease, or impairment of, or assessment of health. Under the CLIA program, unless waived, laboratories must be certified by the government,satisfy governmental quality and personnel standards, undergo proficiency testing, be subject to inspections and pay fees. We have received a CLIA waiverfor all of our lateral flow rapid HIV tests that we market in the United States. Specifically, the CLIA waiver was granted by the FDA for HIV 1/2 STAT-PAK inNovember 2006,for SURE CHECK HIV 1/2 in October 2007, and for DPP HIV 1/2 in October 2014.6 Table of ContentsPervasive and Continuing FDA RegulationA host of regulatory requirements apply to our approved devices, including: the quality system regulation, which requires manufacturers to follow elaboratedesign, testing, control, documentation and other quality assurance procedures; the Medical Reporting Regulations, which require manufacturers to report tothe FDA specified types of adverse events involving their products; labeling regulations; and the FDA’s general prohibition against promoting products forunapproved or “off-label” uses. Some Class II devices are subject to special controls-such as performance standards, post-market surveillance, patientregistries, and FDA guidelines-that do not apply to Class I devices.The regulatory requirements that apply to our approved products classified as medical devices include:• product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action;• QSR, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other qualityassurance procedures during all aspects of the development and manufacturing process;• labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;• clearance of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use of one ofour cleared devices;• approval of product modifications that affect the safety or effectiveness of one of our cleared devices;• medical device reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may have caused orcontributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if themalfunction of the device or a similar device were to recur;• post-approval restrictions or conditions, including post-approval study commitments;• post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness datafor the device;• the FDA’s recall authority, whereby it can ask, or under certain conditions order, device manufacturers to recall from the market a product that is inviolation of governing laws and regulations;• regulations pertaining to voluntary recalls; and,• notices of corrections or removals.Our Medford, New York facility is currently registered as an establishment with the FDA. We and any third-party manufacturers are subject to announced andunannounced inspections by the FDA to determine our compliance with QSR and other regulations.21st Century Cures ActThe 21st Century Cures Act, enacted in December 2016, contains several sections specific to medical device innovations. We believe that implementation ofthe 21st Century Cures Act may have a positive impact on its businesses by facilitating innovation and/or reducing the regulatory burden imposed onmedical device manufacturers.Government Regulation of Medical Devices for Animal SubjectsWe currently sell, market or distribute two veterinary devices in the United States: DPP VetTB Assay for Cervids and DPP VetTB Assay for Elephants.Diagnostic tests for animal health infectious diseases, including our veterinary devices for the prevention and/or treatment of animal disease, are regulated inthe U.S. by the Center for Veterinary Biologics within the U.S. Department of Agriculture Animal and Plant Health Inspection Service, or APHIS, under theVirus, Serum, and Toxin Act of 1913. As a requirement, our veterinary devices were approved by APHIS before they could be sold in the U.S.The APHIS regulatory approval process involves the submission of product performance data and manufacturing documentation. Following regulatoryapproval to market a product, APHIS requires that each lot of product be submitted for review before release to customers. In addition, APHIS requires specialapproval to market products where test results are used in part for government-mandated disease management programs. Environmental LawsWe believe that we are in compliance with all foreign, federal, state, and local environmental regulations with respect to our manufacturing facilities. Thecost of ongoing compliance with such regulations does not have a material effect on our operations.Intellectual PropertyIntellectual Property StrategyOur intellectual property strategy is to: (1) build our own intellectual property portfolio around our DPP technology and optical analyzers; (2) pursuelicenses, trade secrets and know-how within the area of rapid point-of-care testing; and, (3) develop and acquire proprietary positions to certain reagents.7 Table of ContentsDPP® Intellectual PropertyWe have obtained patent coverage on our DPP technology, including numerous patents in the United States, China, Malaysia, Eurasia, Mexico, Singapore,Japan, Australia, Indonesia, Korea and the U.K. Additional patent applications on our DPP technology are pending in the United States, as well as in foreigncountries such as Brazil, Canada, the European Union, India, Israel, and South Africa. DPP technology provides us with freedom to operate, which enables us to develop tests with better performance and capabilities compared with tests built ontraditional lateral flow platforms. These advantages have allowed us to enter into multiple technology collaborations based upon DPP technology, which webelieve will provide new manufacturing and marketing opportunities. We have filed additional patent applications that we believe will strengthen the DPPintellectual property and have also filed for patent protection for certain other point-of-care technologies or applications thereof.We have also obtained patent coverage on our optical-based analyzer technology in the United States, with patents pending in several foreign countries.TrademarksWe have filed and obtained trademarks for our products, including DPP, SURE CHECK, STAT-VIEW, and STAT-PAK, and NEXT GENERATION DPP, aswell as for the SampleTainer and DPP Micro Reader, which are used with certain DPP products. Our trademarks have been obtained in the United States andcertain other countries around the world.Trade Secrets and Know-HowWe have developed a substantial body of trade secrets and know-how relating to the development and manufacture of lateral flow and DPP-based diagnostictests, including the sourcing and optimization of materials for such tests, and methods to maximize sensitivity, speed-to-result, specificity, stability andreproducibility of our tests. We possess proprietary know-how to develop tests for multiple conditions using colored particles. Our formulations enable longshelf lives of our rapid HIV and other tests, providing us with an important competitive advantage.Lateral Flow Technology and Reagent LicensesWe seek licenses and/or redesigns of products that we believe to be in our best interests. Because of the costs and other negative consequences of time-consuming patent litigation, we often attempt to obtain a license on reasonable terms.The peptides used in our rapid HIV tests were licensed to us by one or more third parties. We also have licensed the antigens used in other tests including ourSyphilis, Tuberculosis, Leptospirosis, Leishmaniasis and Chagas tests, and we may enter into other license agreements. In prior years, we concluded licenseagreements related to intellectual property rights owned by the United States associated with HIV-1 and a sub-license agreement for HIV-2 with Bio-RadLaboratories N.A., the exclusive licensee of the Pasteur Institute's HIV-2 intellectual property estate. Available InformationWe are required to file annual, quarterly and current reports, proxy statements and other information with the U.S. Securities and Exchange Commission. TheSEC maintains a website at www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers that fileelectronically with the SEC.Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, proxy statements and amendments to those documentsfiled or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, are also available free of charge on our website atwww.chembio.com as soon as reasonably practicable after such reports are electronically filed with or furnished to the SEC.Investors should note that we currently announce material information to our investors and others using filings with the SEC, press releases, publicconference calls, webcasts or our website (www.chembio.com), including news and announcements regarding our financial performance, key personnel, ourbrands and our business strategy. Information that we post on our corporate website could be deemed material to investors. We encourage investors to reviewthe information we post on these channels. We may from time to time update the list of channels we will use to communicate information that could bedeemed material and will post information about any such change on www.chembio.com. The information on our website is not, and shall not be deemed tobe, a part hereof or incorporated into this or any of our other filings with the SEC.Corporate InformationOur principal executive offices are located at 3661 Horseblock Road, Medford, New York 11763. Our telephone number is (631) 924-1135. Our websiteaddress is www.chembio.com. The information contained in, or accessible through, our corporate website does not constitute part of this report.8 Table of ContentsITEM 1A.RISK FACTORSYou should carefully consider each of the following risk factors and all of the other information provided in this Form 10-K in considering whether to makeor continue to hold an investment in our Common Stock. The risks described below are those we currently believe may materially affect us. An investment inour Company involves a high degree of risk, and should be considered only by persons who can afford the loss of their entire investment. Although webelieve that these risks are the most important for you to consider, you should read this section in conjunction with our financial statements, the notes tothose financial statements and our management's discussion and analysis of financial condition and results of operations included in our periodic reportsand incorporated into this Form 10-K by reference.Risks Related to Our BusinessImportant competitive factors for our products include price, quality, performance, ease of use, and customer service. A few large corporations produce a widevariety of diagnostic tests and other medical devices and equipment. A larger number of mid-size companies generally compete only in the diagnosticindustry and a significant number of small companies produce only a few diagnostic products. As a result, the diagnostic test industry is highly fragmentedand segmented.9 Table of Contents More generally, the point-of-care diagnostics industry is undergoing rapid technological changes, with frequent introductions of new technology-drivenproducts and services. As new technologies become introduced into the point-of-care diagnostic testing market, we may be required to commit considerableadditional efforts, time and resources to enhance our current product portfolio or develop new products. We may not have the available time and resources toaccomplish this, and many of our competitors have substantially greater financial and other resources to invest in technological improvements. We may notbe able to effectively implement new technology-driven products and services or be successful in marketing these products and services to our customers,which would materially harm our operating results.Although we own DPP patents, lateral flow technology is still a competitive platform to DPP, and lateral flow technology has a lower cost of manufacturethan DPP products. Although the DPP platform has shown improved sensitivity as compared with conventional lateral flow platforms in a number of studies,several factors go into the development and performance attributes of products. Therefore the ability of our products to successfully compete will depend onseveral other factors, including our having a patented rapid test platform technology that differentiates DPP from lateral flow as well as from other diagnosticplatform technologies.There can be no assurance that our DPP patents or our products incorporating those patents will not be challenged at some time in the future.Our Competitors may Develop and Commercialize More Effective or Successful Products, and Our Research, Development and CommercializationEfforts may not Succeed.We regularly commit substantial resources to research and development and the commercialization of our new or enhanced products. The research anddevelopment process usually takes a long time from inception to commercial launch. During each stage of this process there is a substantial risk that we willnot achieve our goals in a timely fashion, or at all, and we may have to abandon a new or enhanced product in which we have invested substantial time andmoney. We expect to continue to incur significant costs related to our research and development activities.Our products require significant development and investment prior to commercialization, including testing to demonstrate the products' performancecapabilities, cost-effectiveness or other benefits. We must obtain regulatory approval before most products may be sold and additional development effortson these products may be required before the products will be reviewed. However, regulatory authorities may not approve these products for commercial saleor may substantially delay or condition such approval. There may be little or no market for the product and entry into or development of new markets for ourproducts may require an investment of substantial resources even if all applicable regulatory approvals are obtained. Furthermore, we may spend a significantamount of money on advertising or other activities and still fail to develop a market for the product. The success of our efforts may be affected by our abilityto manufacture products in a cost-effective manner, whether we can obtain necessary intellectual property rights and protection and our ability to obtainreimbursement authorizations in the markets where the product will be sold. Therefore, if we fail to develop and gain commercial acceptance for our products,or if competitors develop more effective products or a greater number of successful new products, customers may decide not to purchase our products.Our Products may not be Able to Compete with New Diagnostic Products or Existing Products Developed by Well-Established Competitors, whichwould Negatively Affect Our Business.The diagnostic industry is focused on the testing of biological specimens in a laboratory or at the point-of-care and is highly competitive and rapidlychanging. Important competitive factors for our products include price, quality, performance, ease of use, and customer service.A few large corporations produce a wide variety of diagnostic tests and other medical devices and equipment. A larger number of mid-size companiesgenerally compete only in the diagnostic industry and a significant number of small companies produce only a few diagnostic products. As a result, thediagnostic test industry is highly fragmented and segmented.Some of our principal competitors may have considerably greater financial, technical and marketing resources than we do. Several companies producediagnostic tests that compete directly with our testing product line, including Abbott (Alere), OraSure Technologies and Trinity Biotech. Some competitorsoffer broader product lines and may have greater name recognition than we have. These and other companies have or may have products incorporatingmolecular or other advanced technologies that over time could directly compete with our testing product line. We also face competition from certain of ourdistributors or former customers that have created or may decide to create, their own products to compete with ours.As new products incorporating new technologies enter the market, our products may become obsolete or a competitor's products may be more effective ormore effectively marketed and sold. If our competitors’ products take market share from our products through more effective marketing or competitivepricing, our revenues, margins and operating results could be adversely affected. In addition, our revenues and operating results could be negativelyimpacted if some of our customers internally develop or acquire their own sample collection devices and use those devices in place of our products in orderto reduce costs.Our Future Revenues and Operating Results may be Negatively Affected by Ongoing Consolidation in the Healthcare Industry.There has been a significant amount of consolidation in the healthcare industry. This consolidation has increased the competition to provide goods andservices to customers. In addition, group purchasing organizations and integrated health delivery networks have served to concentrate purchasing decisionsfor some customers, which has also placed pricing pressure on medical device suppliers. Due to ongoing consolidation, there could be additional pressure onthe prices of our products.10 Table of ContentsOur Continued Growth Depends on Retaining Our Current Key Employees and Attracting Additional Qualified Personnel, and We may not be Able todo so.Our success depends to a large extent upon the skills and experience of our executive officers, management and sales, marketing, operations and scientificstaff. We may not be able to attract or retain qualified employees due to the intense competition for qualified personnel among medical products businessesand academic and other research institutions, as well as to geographic considerations, our ability to offer competitive compensation, and benefits, and otherreasons. If we are not able to attract and retain the necessary qualified personnel to accomplish our business objectives, we may experience constraints that willadversely affect our ability to effectively manufacture, sell and market our products to meet the demands of our strategic partners in a timely fashion, or tosupport internal research and development programs. We have entered into employment contracts with our Chief Executive Officer, John Sperzel; our Chief Financial Officer, Neil Goldman; and our ChiefScience & Technology Officer, Javan Esfandiari. Due to the specific knowledge and experience of these executives regarding the industry, technology andmarket generally and to our company specifically, the loss of the services of any one of these executives could have a material adverse effect on us. We havenot obtained a key man insurance policy on any officer other than Mr. Esfandiari.We may not Generate the Expected Benefits of Our Acquisition of opTricon GmbH, and the integration of the Acquisition could Disrupt Our OngoingBusiness, Distract Our Management and Increase Our Expenses.We acquired opTricon GmbH, or opTricon, in November 2018 with the expectation that the acquisition will result in various benefits, including securingglobal commercial rights and reducing cost of goods. Achieving the anticipated benefits of the opTricon acquisition is subject to a number of uncertainties,including whether our business and the business of opTricon can be integrated in an efficient and effective manner. We cannot assure you that we will be ableto accurately forecast the performance or ultimate impact of the opTricon acquisition.It is possible that the integration process could take longer than anticipated and could result in the loss of valuable employees, additional and unforeseenexpenses, the disruption of our ongoing business, processes and systems, or inconsistencies in standards, controls, procedures, practices, policies andcompensation arrangements, any of which could adversely affect our ability to achieve the anticipated benefits of the opTricon acquisition. There may beincreased risk due to integrating financial reporting and internal control systems. The integration process is subject to a number of uncertainties, and noassurance can be given that the anticipated benefits, expense savings and synergies will be realized or, if realized, the timing of their realization. Failure toachieve these anticipated benefits could result in increased costs or decreases in the amount of expected revenues and could adversely affect our futurebusiness, financial condition, operating results and prospects.We have incurred and will continue to incur non-recurring expenses in connection with the opTricon acquisition, including legal, accounting and otherexpenses. Additional unanticipated costs may be incurred following consummation of the opTricon acquisition in the course of the integration of thebusiness of opTricon into our business. We cannot be certain that the realization of efficiencies related to the integration of the two businesses will offset thetransaction and integration costs in the near term or any losses from undiscovered liabilities not covered by an indemnification from the sellers of opTricon.We may not Generate the Expected Benefits of Future Acquisitions or Investments, and they could Disrupt Our Ongoing Business, Distract OurManagement, Increase Our Expenses and Negatively Affect Our Business.As a way for us to grow our business, we may pursue strategic acquisitions or investments. These activities, and their impact on our business, are subject tomany risks, including the following: (i) the benefits expected to be derived from an acquisition or investment may not materialize and could be affected bynumerous factors, such as regulatory developments, insurance reimbursement, our inexperience with new businesses or markets, general economic conditionsand increased competition; (ii) we may be unable to successfully integrate an acquired company’s personnel, assets, management, information technologysystems, accounting policies and practices, products and/or technology into our business; (iii) we may not be able to accurately forecast the performance orultimate impact of an acquired business; and (iv) an acquisition may result in the incurrence of unexpected expenses, stockholder lawsuits, the dilution of ourearnings or our existing stockholders’ percentage ownership, or potential losses from undiscovered liabilities not covered by an indemnification from theseller(s) of the acquired business.If these factors occur, we may be unable to achieve all or a significant part of the benefits expected from an acquisition or investment. This may adverselyaffect our financial condition, results of operations and ability to grow our business or otherwise achieve our financial and strategic objectives.Third-Party Reimbursement Policies and Potential Cost Constraints could Negatively Affect Our Business.The list of our product end-users includes hospitals, physicians and other healthcare providers. If these end-users do not receive adequate reimbursement forthe cost of our products from their patients’ healthcare insurers or payors, the use of our products could be negatively impacted. Furthermore, the net sales ofour products could also be adversely affected by changes in reimbursement policies of government or private healthcare payors.Hospitals, physicians and other healthcare providers who purchase diagnostic products in the United States generally rely on third-party payors, such asprivate health insurance plans, Medicare and Medicaid, to reimburse all or part of the cost of the product. Due to the overall escalating cost of medicalproducts and services, there is increased pressures on the healthcare industry, both foreign and domestic, to reduce the cost of products and services. Giventhe efforts to control and reduce healthcare costs in the United States, available levels of reimbursement may change for our existing products or productsunder development. Third-party reimbursement and coverage may not be available or adequate in either the United States or international markets, currentreimbursement amounts may be decreased in the future and future legislation, and regulation or reimbursement policies of third-party payors, may reduce thedemand for our products or our ability to sell our products on a profitable basis.To the Extent that We are Unable to Collect Our Outstanding Accounts Receivable, Our Operating Results could be Materially Harmed.There may be circumstances and timing that require us to accept payment terms, including delayed payment terms, from distributors or customers, which, ifnot satisfied, could cause financial losses.We generally accept payment terms which require us to ship product before the contract price has been paid fully, and there also are circumstances pursuantto which we may accept further delayed payment terms pursuant to which we may continue to deliver product. To the extent that these circumstances resultin significant accounts receivables and those accounts receivables are not paid on a timely basis, or are not paid at all, especially if concentrated in one ortwo customers, we could suffer financial losses.Ongoing Changes in Healthcare Regulation could Negatively Affect Our Revenues, Business and Financial Condition.There have been several proposed changes in the United States at the federal and state level for comprehensive reforms regarding the payment for, theavailability of and reimbursement for healthcare services. These proposals have ranged from fundamentally changing federal and state healthcarereimbursement programs, including providing comprehensive healthcare coverage to the public under government-funded programs, to minor modificationsto existing programs. One example is the Patient Protection and Affordable Care or the Affordable Care Act, the Federal healthcare reform law enacted in2010.Healthcare reform initiatives will continue to be proposed, and may reduce healthcare related funding in an effort. It is impossible to predict the ultimatecontent and timing of any healthcare reform legislation and its resulting impact on us. If significant reforms are made to the healthcare system in the UnitedStates, or in other jurisdictions, those reforms may increase our costs or otherwise negatively effect on our financial condition and results of operations.In April 2017, the European Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the European UnionMedical Devices Directive and the Active Implantable Medical Devices Directive. Unlike directives, which must be implemented into the national laws ofthe European Economic Area, which we refer to as the EEA, member States, the regulations would be directly applicable, i.e., without the need for adoption ofEEA member State laws implementing them, in all EEA member States and are intended to eliminate current differences in the regulation of medical devicesamong EEA member States. The Medical Devices Regulation, among other things, is intended to establish a uniform, transparent, predictable and sustainableregulatory framework across the EEA for medical devices and ensure a high level of safety and health while supporting innovation. The Medical DevicesRegulation will, however, only become fully applicable three years after publication (in May 2020). Once applicable, the Medical Devices Regulation will,among other things:• strengthen the rules on placing devices on the market and reinforce surveillance once they are available;• establish explicit provisions on manufacturers' responsibilities for the follow-up of the quality, performance and safety of devices placed on themarket;• improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;• set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in theEU; and• strengthen rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts beforethey are placed on the market.Once applicable, the Medical Devices Regulation may impose increased compliance obligations for us to access the EU market.We Believe Our Success Depends in Part on the Continued Funding of, and Our Ability to Participate in, Large Testing Programs in the U.S. andWorldwide, the Funding of which may be Reduced or Discontinued or Otherwise be Unavailable to Us.We believe it to be in our best interests to meaningfully participate in large testing programs. Moreover many of these programs are funded by governmentsand other donors, and there can be no assurance that funding will not be reduced or completely discontinued. Participation in these programs also requiresalignment and engagement with the many other participants in these programs, including WHO, CDC, the U.S. Agency for International Development,foreign governments and their agencies, non-governmental organizations, and HIV service organizations. If we are unsuccessful in our efforts to participatein these programs, our operating results could be materially harmed.11 Table of ContentsIn December 2013 President Obama signed into law the PEPFAR Stewardship and Oversight Act, which is the most recent reauthorization of PEPFAR.However, unlike the 2008 PEPFAR authorization, which authorized approximately $45 billion in funding, the new law did not authorize a specific dollaramount for funding.Developing Testing Guidelines could Negatively Affect Sales of Our Products.Government agencies may issue diagnostic testing guidelines or recommendations, which can alter the usage of our HIV testing products. New laws orguidelines, or changes to existing laws or guidelines, and the manner in which these new or changed laws and guidelines are interpreted and applied, couldimpact the degree to which our testing products are used. These developments could affect the frequency of testing, the number of people tested and whetherthe testing products are used broadly for screening large populations or in a more limited capacity. These factors could in turn affect the level of sales of ourproducts and our results of operations.Legislative and Other Regulatory Changes could have an Effect on Our Business.The current U.S. Presidential Administration has promised to repeal and replace the Affordable Care Act, expressed concerns with respect to existing tradeagreements, and has indicated a desire to make other regulatory changes during his administration. Changes in regulatory or economic conditions or in thelaws and policies governing foreign trade, taxes, manufacturing, and development in the United States could impact our business. Economic and regulatorychanges could also affect foreign currency exchange rates which, in turn, could affect our reported financial results and our competitiveness on a worldwidebasis.Developments Related to the U.K.’s Referendum On Membership in the E.U. Could Adversely Affect Us.On June 23, 2016, the United Kingdom voted in favor of leaving the European Union, or E.U. Following this “Brexit” referendum there has been increasedpolitical and economic uncertainty, particularly in the U.K. and E.U. and this uncertainty may last for the foreseeable future. Until the terms and timing of theU.K.’s exit from the E.U. are finalized, it will be difficult to predict the impact of Brexit. Our business in the U.K., the E.U. and world-wide could benegatively affected during this period of uncertainty, and perhaps longer. The decision of voters in the U.K. to exit the E.U. could cause volatility in globalfinancial markets, such as global currency exchanges, resulting in a slow-down in economic activity in the U.K., Europe or globally, and result in significantregulatory changes and uncertainty. These events could make it more difficult or costly to sell our products, particularly in the U.K. and Europe, andnegatively affect our revenues and results of operations. The Brexit referendum may also influence other countries and result in additional countries decidingto leave the E.U. This in turn could result in additional changes and uncertainty, any or all of which could negatively impact our business.We could be Exposed to Liability if We Experience Security Breaches or Other Disruptions, which could Harm Our Reputation and Business.We may be subject to cyber-attacks whereby computer hackers may attempt to access our computer systems or our third party IT service provider’s systemsand, if successful, misappropriate personal or confidential information. In addition, a contractor or other third party with whom we do business may attempt tocircumvent our security measures or obtain such information, and may purposefully or inadvertently cause a breach involving sensitive information. We willcontinue to evaluate and implement additional protective measures to reduce the risk and detect cyber incidents, but cyber-attacks are becoming moresophisticated and frequent and the techniques used in such attacks change rapidly. Even though we take cyber-security measures that are continuouslyreviewed and updated, our information technology networks and infrastructure may still be vulnerable due to sophisticated attacks by hackers or breaches.Even the most well protected IT networks, systems, and facilities remain potentially vulnerable because the techniques used in security breaches arecontinually evolving and generally are not recognized until launched against a target and, in fact, may not be detected. Any such compromise of our or ourthird party’s IT service providers’ data security and access, public disclosure, or loss of personal or confidential business information, could result in legalclaims proceedings, liability under laws to protect, privacy of personal information, and regulatory penalties, disrupt our operations, require significantmanagement attention and resources to remedy any damages that result, damage our reputation and customers willingness to transact business with us, any ofwhich could adversely affect our business.Our Ability to Efficiently Operate Our Business is Reliant on Information Technology, and Any Material Failure, Inadequacy, Interruption or SecurityBreach of that Technology could Harm Our Business.We rely heavily on complex information technology systems across our operations and on the internet, including for management of inventory, invoices,purchase orders, shipping, interactions with our third-party logistics provider, revenue and expense accounting, consumer call support, online business, andvarious other processes and transactions. Our ability to effectively manage our business, coordinate the production, distribution and sale of our products,respond to customer inquiries, and ensure the timely and accurate recording and disclosure of financial information depends significantly on the reliabilityand capacity of these systems and the internet.If any of the foregoing systems fails to operate effectively, problems with transitioning to upgraded or replacement systems, or disruptions in the operation ofthe internet, could cause delays in product sales and reduced efficiency of our operations. Significant expenditures could be required to fix any such problem.If there is an Increase in Demand for Our Products, it could Require Us to Expend Considerable Resources or Harm Our Customer Relationships if Weare Unable to Meet that Demand.If there are significant or unexpected increases in the demand for our products, we may not be able to meet that demand without expending additional capitalresources. This would increase our capital costs, which could negatively affect our earnings in the short term. In addition, new manufacturing equipment orfacilities may require FDA, WHO, and other regulatory approvals before they can be used to manufacture our products. To the extent we are unable to obtainor are delayed in obtaining such approvals, our ability to meet the demand for our products could be adversely affected. Furthermore, our suppliers may beunable or unwilling to expend the necessary capital resources or otherwise expand their capacity, which could negatively affect our business.Our business could be negatively affected if we or our suppliers are unable to develop necessary manufacturing capabilities in a timely manner. If we fail toincrease production volumes in a cost effective manner or if we experience lower than anticipated yields or production problems as a result of changes thatwe or our suppliers make in our manufacturing processes to meet increased demand, we could experience shipment delays or interruptions and increasedmanufacturing costs, which could also have a material adverse effect on our revenues and profitability.If there are unexpected increases in demand for our products, we may be required to obtain additional raw materials in order to manufacture products to meetthe increase in demand. However, some raw materials require significant ordering lead time and some are currently obtained from a sole supplier or a limitedgroup of suppliers. It is also possible that one or more of our suppliers may become unwilling or unable to deliver materials to us. Any shortfall in our supplyof raw materials and components, or our inability to quickly and cost-effectively obtain alternative sources for this supply, could have a material adverseeffect on our ability to meet increased demand for our products. This could negatively affect our total revenues or cost of sales and related profits.12 Table of ContentsIf we are unable to meet customer demand for our products, it could also harm our relationships with our customers and impair our reputation within theindustry. This, in turn, could have a material adverse effect on our business.Risks Related to Our ProductsFor Our Business to Succeed in the Future, Our Current and Future Products Must Receive Market Acceptance.Market acceptance and the timing of such acceptance, of our new products or technologies is necessary for our future success. To achieve market acceptance,we and our distributors will likely be required to undertake substantial efforts and spend significant funds to inform every one of the existence and perceivedbenefits of our products. We also may require government funding for the purchase of our products to help create market acceptance and expand the use ofour products.It may be difficult evaluate the market reaction to our products and our marketing efforts for new products may not be successful. The government funding wereceive may be limited for new products. As such, there can be no assurance that any products will obtain significant market acceptance and fill the marketneed that is perceived to exist on a timely basis, or at all.We may not have Sufficient Resources to Effectively Introduce and Market Our Products, which could Materially Harm Our Operating Results.Introducing and achieving market acceptance for our new products will require substantial marketing efforts and will require us and/or our contract partners,sales agents, and/or distributors to make significant expenditures of time and money. In some instances we will be significantly or totally reliant on themarketing efforts and expenditures of our contract partners, sales agents, and distributors. If they do not have or commit the expertise and resources toeffectively market the products that we manufacture, our operating results will be materially harmed.New Developments in Health Treatments and Non-Diagnostic Products may Reduce or Eliminate the Demand for Our Products.The development and commercialization of products outside of the diagnostics industry could adversely affect sales of our products. For example, thedevelopment of a safe and effective vaccine to HIV or treatments for other diseases or conditions that our products are designed to detect, could reduce oreventually eliminate the demand for our HIV or other diagnostic products and result in a loss of revenues.Sales Cycles for Our Products can be Lengthy, which can Cause Variability and Unpredictability in Our Business.Some of our products may require lengthy and unpredictable sales cycles, which makes it more difficult to accurately forecast revenues in a given period andmay cause revenues and operating results to vary from period to period. Our products may involve sales to large public and private institutions which mayrequire many levels of approval and may be dependent on economic or political conditions and the availability of grants or funding from government orpublic health agencies which can vary from period to period. There can be no assurance that purchases or funding from these agencies will occur or continue,especially if current negative economic conditions continue or intensify. As a result, we may expend considerable resources on unsuccessful sales efforts orwe may not be able to complete transactions at all or on a schedule and in an amount consistent with our objectives.We May Face Product Liability Claims for Injuries.The testing, manufacturing and marketing of medical diagnostic products involves an inherent risk of product liability claims. If we cannot successfullydefend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or cease sales of our products. We cannot be surethat we will not incur liabilities in excess of the policy limits of our existing product liability insurance coverage or that we will be able to continue to obtainadequate product liability insurance coverage in the future at an acceptable cost, or at all. In addition, a defect in the design or manufacture of our productscould have a material adverse effect on our reputation in the industry and subject us to claims of liability for injury and otherwise. Any substantialunderinsured loss resulting from such a claim could have a material adverse effect on our profitability, and the damage to our reputation in the industry couldhave a material adverse effect on our business.Our Customers may not Adopt Rapid Point-of-Care Diagnostic Testing.Rapid point-of-care tests are beneficial because, among other things, they can be administered by healthcare providers in their own facilities or used byconsumers at home without sending samples to central laboratories. But currently the majority of diagnostic tests used by physicians and other healthcareproviders in the U.S. are provided by clinical reference laboratories and hospital-based laboratories. In some international markets, such as Europe, diagnostictesting is performed primarily by centralized laboratories. Future sales of our products will depend, in part, on our ability to expand market acceptance ofrapid point-of-care testing and successfully compete against laboratory testing methods and products. However, we expect that clinical reference and otherhospital-based laboratories will continue to compete vigorously against our rapid point-of-care products. Even if we can demonstrate that our products aremore cost effective, save time, or have better performance or other benefits, physicians, other healthcare providers and consumers may resist changing to rapidpoint-of-care tests and instead may choose to obtain diagnostic results through laboratory tests. If we fail to achieve and expand market acceptance of ourrapid point-of-care diagnostic tests with customers, it would have a negative effect on our future sales growth.Customer Concentration Creates Risks for Our Business.A significant portion of our revenues each year comes from a few large customers. To the extent that such a large customer fails to meet its purchasecommitments, changes its ordering patterns or business strategy, or otherwise reduces its purchases or stops purchasing our products, or if we experiencedifficulty in meeting the demand by these customers for our products, our revenues and results of operations could be adversely affected.13 Table of ContentsIf Our Products do not Perform Properly, It may Affect Our Revenues, Stock Price and Reputation.Our products may not perform as expected. For example, a defect in one of our diagnostic products or a failure by a customer to follow proper testingprocedures may cause the product to report inaccurate information. Identifying the root cause of a product performance or quality issue can be difficult andtime consuming.If our products do not to perform in accordance with the applicable label claims or otherwise in accordance with the expectations or needs of our customers,customers may switch to a competing product or otherwise stop using our products, and our revenues could be negatively affected. If this occurs, we may berequired to implement holds or product recalls and incur warranty obligations. Furthermore, the poor performance by one or more of our products could havean adverse effect on our reputation, our continuing ability to sell products and the price of our Common Stock.If We Expand Our International Presence, It may Increase Our Risks and Expose Our Business to Regulatory, Cultural or Other Challenges.We will continue to try to increase revenue derived from international sales of our products. There are several of factors that could adversely affect theperformance of our business and/or cause us to incur substantially increased costs because of our international presence and sales, including: (i) uncertaintyin the application of foreign laws and the interpretation of contracts with foreign parties; (ii) cultural and political differences that favor local competitors ormake it difficult to effectively market, sell and gain acceptance of our products; (iii) exchange rates, currency fluctuations, tariffs and other barriers, extendedpayment terms and dependence on international distributors or representatives; (iv) trade protection measures, trade sanctions and import/export licensingrequirements; (v) our inability to obtain or maintain regulatory approvals or registrations for our products; (vi) Economic conditions, political instability, theabsence of available funding sources, terrorism, civil unrest, war and natural disasters in foreign countries; (vii) Reduced protection for, or enforcement of, ourpatents and other intellectual property rights in foreign countries; (viii) our inability to identify international distributors and negotiate acceptable terms fordistribution agreements; and (ix) restrictions on our ability to repatriate investments and earnings from foreign operations.Economic, cultural and political conditions and foreign regulatory requirements may slow or prevent the manufacture of our products in countries other thanthe United States. Interruption of the supply of our products could reduce revenues or cause us to incur significant additional expenses in finding analternative source of supply. Foreign currency fluctuations and economic conditions in foreign countries could also increase the costs of manufacturing ourproducts in foreign countries.Financial Results, Economic, and Financing RisksWe incurred an operating loss each year from 2014 through 2018. Under our operating plan, we have made, and plan to continue to make, significantinvestments in our production capacity, including in expanding facilities and automating manufacturing, and in our sales and marketing, regulatoryapproval, and research and development activities. Our ability to achieve profitability and generate cash flow in the future will depend on our ability toincrease sales of our existing products and to successfully introduce new and enhanced products into the marketplace, all while controlling and managingour expenses consistent with our operating plan.If we are unable to increase our revenues and manage our expenses in accordance with our operating plan, our operating results would be harmed and we maynot be able to generate the cash flow needed to fund the investments in our production capacity and other activities, we will be required to implement one orboth of the following:• We could reduce the level, or otherwise delay the timing, of the anticipated investments in our production capacity and other activities, whichwould likely curtail or delay the growth in our business contemplated by our operating plan and could impair or defer our ability to achieveprofitability and generate cash flow.• We could raise additional funds through public or private financings, strategic relationships, or other arrangements, to the extent funding would beavailable to us on acceptable terms or at all. If we succeed in raising additional funds through the issuance of equity or convertible securities, thenthe issuance could result in substantial dilution to existing stockholders. Furthermore, the holders of these new securities or debt may have rights,preferences and privileges senior to those of the holders of our Common Stock.In such circumstances, we also would need to forego acquisition opportunities, which could impede our ability to grow our business.14 Table of ContentsWe Base Our Estimates or Judgments Relating to Critical Accounting Policies on Assumptions that can Change or Prove to be Incorrect.Our financial statements have been prepared in accordance with accounting principles generally accepted in the United States and our discussion andanalysis of financial condition and results of operations is based on such statements. The preparation of financial statements requires management to makeestimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. We continuously evaluate significantestimates used in preparing our financial statements, including those related to (i) revenue recognition; (ii) stock-based compensation; (iii) allowance foruncollectible accounts receivable; (iv) inventory reserves and obsolescence; (v) customer sales returns and allowances; (vi) contingencies; and (vii) incometaxes.Our estimates are based on historical experience and various other assumptions that we believe to be reasonable, as set forth in our discussion and analysis offinancial condition and results of operations, the results of which form the basis for making judgments about the carrying values of assets and liabilities thatare not readily apparent from other sources. Actual results may differ from these and other estimates if our assumptions change or if actual circumstances differfrom those in our assumptions. If our operating results fall below the expectations of securities analysts and investors, the price of our Common Stock maydecline.Our Financial Results may Fluctuate.From quarter to quarter and year to year, our operating results can fluctuate, which could cause our growth or financial performance to fail to meet theexpectations of investors and securities analysts. Sales to our distributors and other customers may not meet expectations because of lower than expectedcustomer demand or other factors, including continued economic volatility and disruption, reduced governmental funding, and other circumstancesdescribed elsewhere in this report. A variety of factors could also contribute to the variability of our financial results, including infrequent, unusual orunexpected changes in revenues or costs.Different products provide dissimilar contributions to our gross product margin. Accordingly, our operating results could also fluctuate and be negativelyaffected by the mix of products sold and the relative prices and gross product margin contribution of those products. Failure to achieve operating resultsconsistent with the expectations of investors and securities analysts could adversely affect our reputation and the price of our Common Stock.Our Operating Results may be Negatively Affected by Changes in Foreign Currency Exchange Rates.In the past our exposure to foreign currency exchange rate risk has not been material. Nevertheless, sales of our products are subject to currency risks, sincechanges in the values of foreign currencies relative to the value of the U.S. dollar can render our products comparatively more expensive. The fluctuations inthe exchange rate could negatively impact international sales of our products, as could changes in the general economic conditions.The revenues and expenses of Chembio Diagnostics Malaysia, one of our subsidiaries, are recorded in Malaysian Ringgit. The revenues and expenses ofopTricon are recorded in Euros. Revenues and expenses denominated in foreign currencies are translated into U.S. dollars for purposes of reporting ourconsolidated financial results. Our expectation is that the Chembio Diagnostics Malaysia and opTricon businesses will continue to grow and, consequently,our exposure to foreign currency exchange rates may grow as well.Our foreign subsidiaries' revenues and expenses and the translation of their financial results into U.S. dollars may be negatively affected by fluctuations in theexchange rate. Favorable movement in exchange rates have benefited us in prior periods. However, where there are unfavorable currency exchange ratefluctuations, our consolidated financial statements could be negatively affected. Furthermore, fluctuations in exchange rates could affect year-to-yearcomparability of operating results. In the past, we have not generally entered into hedging instruments to manage our currency exchange rate risk, but wemay need to do so in the future. However, our attempts to hedge against these risks may not be successful. If we are unable to successfully hedge againstunfavorable foreign currency exchange rate movements, our consolidated financial results may be adversely impacted.Changes in Interpretation or Application of U.S. Generally Accepted Accounting Principles may Adversely Affect Our Operating Results.We prepare our financial statements to conform to U.S. generally accepted accounting principles. These principles are subject to interpretation by theFinancial Accounting Standards Board, the American Institute of Certified Public Accountants, the Public Company Accounting Oversight Board, theSecurities and Exchange Commission and various other regulatory or accounting bodies. A change in interpretations of, or our application of, theseprinciples can have a significant effect on our reported results and may even affect our reporting of transactions completed before a change is announced.Additionally, as we are required to adopt new accounting standards, our methods of accounting for certain items may change, which could cause our resultsof operations to fluctuate from period to period. For example, upon adoption of Accounting Standards Codification (“ASC”) 606 Revenue from Contractswith Customers of the Financial Accounting Standards Board (“FASB”), we now recognize revenue upon transfer of control, which is generally at time ofdelivery. Under the previous accounting guidance, we recognized revenue upon acceptance when and if we had production responsibilities. If circumstanceschange over time or interpretation of the revenue recognition rules change, we could be required to adjust the timing of recognizing revenue and ourfinancial results could suffer.15 Table of ContentsOur Business may be Negatively Affected by Terrorist Attacks or Natural Disasters.Terrorist attacks or natural disasters could cause economic instability. These events could negatively affect economic conditions both within and outside theUnited States and harm demand for our products. The operations of our customers and suppliers could be negatively impacted and eliminate, reduce or delayour customers’ ability to purchase and use our products and our suppliers’ ability to provide raw materials and finished products.Our facilities, including some pieces of manufacturing equipment and our computer systems, may be difficult to replace. Various types of disasters, includingfires, earthquakes, floods and acts of terrorism, may affect our facilities and computer systems. In the event our existing facilities or computer systems areaffected by man-made or natural disasters, we may have difficulty operating our business and may be unable to manufacture products for sale or meetcustomer demands or sales projections. If our manufacturing operations were curtailed or shut down entirely, it would seriously harm our business.We Operate in Countries where there is or may be Widespread Corruption.We have a policy in place prohibiting our employees, distributors and agents from engaging in corrupt business practices, including activities prohibited bythe U.S. Foreign Corrupt Practices Act. Nevertheless, because we work through independent sales agents and distributors outside the United States, we do nothave control over the day-to-day activities of such independent agents and distributors. In addition, in the donor-funded markets in Africa where we sell ourproducts, there is significant oversight from PEPFAR, the Global Fund, and advisory committees comprised of technical experts concerning the developmentand establishment of national testing protocols. This is a process that includes an overall assessment of a product which includes extensive productperformance evaluations including five active collaborations and manufacturer's quality systems, as well as price and delivery. In Brazil, where we have hadnumerous product collaborations with FIOCRUZ, the programs through which our products may be deployed are all funded by the Brazilian Ministry ofHealth. Although FIOCRUZ is affiliated with the Brazilian Ministry of Health, and is its sole customer, FIOCRUZ is not the exclusive supplier for theMinistry of Health. However, because each of our previous collaborations with FIOCRUZ incorporates a technology transfer aspect, we believe we have acompetitive advantage versus other suppliers to the Brazilian Ministry of Health, assuming other aspects of our product offering through FIOCRUZ areotherwise competitive in comparison. We have no knowledge or reason to know of any activities by our employees, distributors or sales agents of any actionswhich could be in violation of the FCPA, although there can be no assurance of this.Our subsidiary Chembio Diagnostics Malaysia Sdn. Bhd. is located in Malaysia. There have been numerous high-profile corruption cases, and corruption isone of the most problematic factors for doing business in Malaysia. While the Malaysian government has acknowledged the problem, it appears that endemiccorruption is continuing and that market-based principles are not applied in cases involving individuals with high-level political access. To the extentbribery and similar practices continue to exist in Malaysia, U.S. companies such as ours, which are subject to U.S. laws making it illegal to pay bribes toforeign officials, may make us less competitive in winning business in Malaysia when competing with non-U.S. companies.Risks Related to Intellectual PropertyOur Success Depends on Our Ability to Protect Our Proprietary Technology. We Rely on Trade Secret Laws and Agreements with Our Key Employeesand Other Third Parties to Protect Our Proprietary Rights, and We cannot be sure that these Laws or Agreements will Adequately Protect Our Rights.Our industry places considerable importance on obtaining patent, trademark and trade secret protection, as well as other intellectual property rights, for newtechnologies, products and processes. Our success depends, in part, on our ability to develop and maintain a strong intellectual property portfolio or obtainlicenses to patents and technologies, both in the United States and in other countries. If we cannot continue to develop, obtain and protect intellectualproperty rights, our revenues and gross profits could be adversely affected. Moreover, our current and future licenses or other rights to patents and othertechnologies may not be adequate for the operation of our business.As appropriate, we intend to file patent applications and obtain patent protection for our proprietary technology. These patent applications and patents willcover, as applicable, compositions of matter for our products, methods of making those products, methods of using those products and apparatuses relating tothe use or manufacture of those products. However, there have been changes to the patent laws and proposed changes to the rules of the U.S. Patent andTrademark Office, which may impact our ability to protect our technology and enforce our intellectual property rights. For example, in 2011, the U.S. enactedsweeping changes to the U.S. patent system under the Leahy-Smith America Invents Act, including changes that would transition the U.S. from a “first-to-invent” system to a “first-to-file” system and alter the processes for challenging issued patents. These changes could increase the uncertainties and costssurrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.We believe that factors such as the technological and creative skills of our personnel, strategic relationships, new product developments, frequent productenhancements and name recognition are essential to our success. All our management personnel are bound by non-disclosure agreements. If personnel leaveour employment, in some cases we would be required to protect our intellectual property rights pursuant to common law theories which may be lessprotective than provisions of employment, non-competition or non-disclosure agreements.We seek to protect our proprietary products under trade secret and copyright laws, enter into license agreements for various materials and methods employedin our products, and enter into strategic relationships for distribution of the products. These strategies afford only limited protection. We currently havesome foreign patents issued, and we are seeking additional patent protection in several other foreign jurisdictions for our DPP and optical technology. Wehave licenses to reagents (antigens and peptides) used in several of our products and products under development. Despite our efforts to protect ourproprietary assets, and respect the intellectual property rights of others, we participate in several markets where intellectual property rights protections are oflittle or no value. This can place our products and our company at a competitive disadvantage.Moreover, issued patents remain in effect for a fixed period and after expiration will not provide protection of the inventions they cover. Once our patentsexpire, we may be faced with increased competition, which could reduce our revenues. We may also not be able to successfully protect our rights tounpatented trade secrets and know-how.To facilitate development and commercialization of a proprietary technology base, we may need to obtain additional licenses to patents or other proprietaryrights from other parties. Obtaining and maintaining these licenses, which may not be available, may require the payment of up-front fees and royalties. Inaddition, if we are unable to obtain these types of licenses, our product development and commercialization efforts may be delayed or precluded.Any Future Intellectual Property Disputes could Require Significant and Limit or Eliminate Our Ability to Sell Products or Use Certain Technologies.We may be required to expend substantial resources in asserting or protecting our intellectual property rights, or in defending suits related to intellectualproperty rights. We may seek to enforce our patents or other intellectual property rights through litigation. Such litigation is prevalent and is expected tocontinue. In our business, there are a large number of patents and patent applications similar to our products, and additional patents may be issued to thirdparties relating to our product areas. We, our customers or our suppliers may be sued for infringement of patents or misappropriation of other intellectualproperty rights with respect to one or more of our products. We may also have disputes with parties that license patents to us if we believe the license is nolonger needed for our products or the licensed patents are no longer valid or enforceable.There are a large number of patents in our industry, and the claims of these patents appear to overlap in many cases. Therefore there is a significant amount ofuncertainty regarding the extent of patent protection and infringement. Companies may have pending patent applications, which are typically confidentialfor the first eighteen months following filing that cover technologies we incorporate in our products. Accordingly, we may be subjected to substantialdamages for past infringement or be required to modify our products or stop selling them if it is ultimately determined that our products infringe a thirdparty’s proprietary rights. In addition, governmental agencies could commence investigations or criminal proceedings against our employees or us relating toclaims of misuse or misappropriation of another party’s proprietary rights.If we are involved in litigation or other legal proceedings with respect to patents or other intellectual property and proprietary technology, it could adverselyaffect our revenues, results of operations, market share and business because (1) it could consume a substantial portion of managerial and financial resources;(2) its outcome would be uncertain and a court may find that our patents are invalid or unenforceable in response to claims by another party or that the third-party patent claims are valid and infringed by our products; (3) the pendency of any litigation may in and of itself cause our distributors and customers toreduce or terminate purchases of our products; (4) a court could award a preliminary and/or permanent injunction, which would prevent us from selling ourcurrent or future products; and (5) an adverse outcome could subject us to the loss of the protection of our patents or to liability in the form of past royaltypayments, penalties, reimbursement of litigation costs and legal fees, special and punitive damages, or future royalty payments, any of which couldsignificantly affect our future earnings.16 Table of ContentsUnder certain contracts with third parties, we may indemnify the other party if our products or activities have actually or allegedly infringed upon,misappropriated or misused another party’s proprietary rights. Furthermore, our products may contain technology provided to us by third parties, and we maybe unable to determine in advance whether such technology infringes the intellectual property rights of a third party. These other parties may also not berequired or financially able to indemnify us in the event that an infringement or misappropriation claim is asserted against us.There may also be other types of disputes that we become involved in regarding intellectual property rights, including state, federal or foreign courtlitigation, and patent interference, patent reissue, patent reexamination, or trademark opposition proceedings in the United States Patent and TrademarkOffice. Opposition or revocation proceedings could be instituted in a foreign patent office as well. These proceedings permit certain persons to challenge thevalidity of a patent on the grounds that it was known from the prior art. The filing of such proceedings, or the issuance of an adverse decision in suchproceedings, could result in the loss of valuable patent rights that could have a material adverse effect on our business, financial condition, results ofoperations and growth prospects.Risks Related to Our Third Party CollaboratorsOur Use of Third-Party Suppliers, some of which may Constitute Our Sole Supply Source, for Certain Important Product Components and MaterialsPresents Risks that Could Have Negative Consequences for Our Business.We purchase certain HIV antigens, a syphilis antigen, the nitrocellulose, and certain other critical components used in our STAT-PAK, STAT-VIEW, SURECHECK and DPP product lines from a sole or limited number of sources. If for any reason these suppliers become unwilling or unable to supply our antigen,nitrocellulose, or other critical component needs, we believe that alternative supplies could be obtained at a competitive cost. However, a change in any ofthe antigens, nitrocellulose or other critical components used in our products would require additional development work and approval by the FDA and otherregulatory agencies. In addition, it may be difficult to find such an alternate supply source in a reasonable time period or on commercially reasonable terms,if at all. As a result, the termination or limitation of our relationship with one or more of these suppliers could require significant time to complete, increaseour costs, and disrupt or discontinue our ability to manufacture and sell the affected products.With some of these suppliers, we do not have long-term agreements and instead purchase components and materials through a purchase order process. As aresult, these suppliers may stop supplying us components and materials, limit the allocation of supply and equipment to us due to increased industry demand,or significantly increase their prices at any time with little or no advance notice. Our reliance on a limited number of suppliers could also result in deliveryproblems, reduced control over product pricing and quality, and our inability to identify and qualify another supplier in a timely manner.Moreover, some of these suppliers may experience financial difficulties that could prevent them from supplying us with components or subassemblies used inthe design and manufacture of our products. In addition, these suppliers may experience manufacturing delays or shut downs due to circumstances beyondtheir control, such as labor issues, political unrest or natural disasters.Any supply deficiencies could materially and adversely affect our ability to fulfill customer orders and our results of operations. The availability of criticalcomponents and materials from sole- or limited source suppliers could reduce our control over pricing, quality and timely delivery, increase our costs, coulddisrupt our ability to manufacture and sell, and preclude us from manufacturing and selling, certain of our products into one or more markets. Any such eventcould have a material adverse effect on our results of operations, cash flow and business.We May Work with Strategic Collaborators to Assist in Developing and Commercializing Our Products, which could Limit Rights We Receive from theCollaborations and Exposes Us to Other Risks Outside Our Control.Some business opportunities that require a technology controlled by a third party, a significant level of investment for development and commercializationor a distribution network beyond our existing sales force may necessitate involving one or more strategic collaborators. As part of our strategy fordevelopment and commercialization of our products, we may enter into arrangements with distributors or other third-parties. Relying on such collaborativerelationships could be risky to our business for a number of reasons, including: (i) we may be required to transfer material rights to such strategiccollaborators, licensees and others; (ii) our collaborators may not obtain regulatory approvals necessary to continue the collaborations in a timely manner;(iii) our collaborators may decide to terminate our collaborative arrangement or become insolvent; (iv) our collaborators may develop technologies orcomponents competitive with our products; (v) disagreements with collaborators could result in the termination of the relationship or litigation; and (vi) wemay not be able to agree to future collaborative arrangements, or renewals of existing collaborative agreements, on acceptable terms or at all.We expect our collaborators will have an economic motivation to succeed in performing their contractual responsibilities under our agreements, there is noassurance that they will do so. Due to our reliance on strategic agreements, it can make it difficult to accurately forecast our future revenues and operatingresults.Our Ability to Grow Our Business will be Limited if We Fail to Maintain Existing Distribution Channels or Develop New Distribution Channels.We collaborate with laboratories, diagnostic companies and distributors in order to sell our products. The sale of our products depends in large part on ourability to sell products to these customers and on the marketing and distribution abilities of the companies with which we collaborate and work with.By relying on distributors or third-parties to market and sell our products could negatively impact our business for various reasons, including: (i) we may notbe able to find suitable distributors for our products on satisfactory terms, or at all; (ii) agreements with distributors may prematurely terminate or may resultin litigation between the parties; (iii) our distributors or other customers may not fulfill their contractual obligations and distribute our products in themanner or at the levels we expect; (iv) our distributors may prioritize their own private label products that compete with our products; (v) Our existingdistributor relationships or contracts may preclude or limit us from entering into arrangements with other distributors; and (vi) we may not be able tonegotiate new or renew existing distribution agreements on acceptable terms, or at all.We will try to maintain and expand our business with distributors and customers and make every effort to require that they fulfill their contractualobligations, but there can be no assurance that such companies will do so or that new distribution channels will be available on satisfactory terms. If we areunable to do so, our business will be negatively impacted.Our U.S. Government Contracts Require Compliance with Numerous Laws and Increases Our Risk and Liability.We are currently receiving funding from the U.S. government related to DPP Zika, and our growth strategy targets sales to U.S. government entities. As aresult of our U.S. government funding and potential product sales to the U.S. government, we must comply with laws and regulations relating to the award,administration and performance of U.S. government contracts. U.S. government contracts typically contain a number of extraordinary provisions that wouldnot typically be found in commercial contracts and which may create a disadvantage and additional risks to us as compared to competitors that do not rely ongovernment contracts. As a U.S. government contractor, we are subject to increased risks of investigation, criminal prosecution and other legal actions andliabilities to which purely private sector companies are not. The results of any such actions could adversely impact our business and have an adverse effect onour consolidated financial performance.A violation of specific laws and regulations could result in the imposition of fines and penalties or the termination of our contracts, as well as suspension ordebarment. The suspension or debarment in any particular case may be limited to the facility, contract or subsidiary involved in the violation or could beapplied to our entire enterprise in certain severe circumstances. Even a narrow scope suspension or debarment could result in negative publicity that couldadversely affect our ability to renew contracts and to secure new contracts, both with the U.S. government and private customers, which could materially andadversely affect our business and results of operations. Fines and penalties could be imposed for failing to follow procurement integrity and bidding rules,employing improper billing practices or otherwise failing to follow rules relating to billing on cost-plus contracts, receiving or paying kickbacks, or filingfalse claims, among other potential violations. In addition, we could suffer serious reputational harm and the value of our Common Stock could be negativelyaffected if allegations of impropriety related to such contracts are made against us.Our U.S. Government Contracts are Subject to Future Funding and the Government’s Choice to Exercise Options, and may be Terminated at theGovernment’s Convenience.Our contracts with the U.S. government are subject to future funding and are subject to the right of the government to terminate the contracts in whole or inpart for its convenience. There is pressure for the U.S. government to reduce spending. The non-appropriation of funds or the termination for thegovernment’s convenience of our contracts could negatively affect our financial results. If levels of U.S. government expenditures and authorizations foremerging diseases decrease or shift to programs in areas where we do not offer products or are not developing product candidates, or if the U.S. governmentotherwise declines to exercise its options under its contracts with us, our business, revenues and other operating results would suffer.Risks Related to RegulationsBecause We may not be Able to Obtain or Maintain the Necessary Regulatory Approvals for Some of Our Products, We may not Generate Revenues inthe Amounts We Expect, or in the Amounts Necessary to Continue Our Business. Our Existing Products as well as Our Manufacturing Facility MustMeet Quality Standards and are Subject to Inspection by a Number of Domestic Regulatory and Other Governmental and Non-Governmental Agencies.All of our proposed and existing products are subject to regulation in the U.S. by the U.S. Food and Drug Administration, the U.S. Department of Agricultureand/or other domestic and international governmental, public health agencies, regulatory bodies or non-governmental organizations. In particular, we aresubject to strict governmental controls on the development, manufacture, labeling, distribution and marketing of our products. The process of obtainingrequired approvals or clearances varies according to the nature of, and uses for, a specific product. These processes can involve lengthy and detailedlaboratory testing, human or animal clinical trials, sampling activities, and other costly, time-consuming procedures. The submission of an application to aregulatory authority does not guarantee that the authority will grant an approval or clearance for that product. Each authority may impose its ownrequirements and can delay or refuse to grant approval or clearance, even though a product has been approved in another country.The time taken to obtain approval or clearance varies depending on the nature of the application and may result in the passage of a significant period of timefrom the date of submission of the application. Delays in the approval or clearance processes increase the risk that we will not succeed in introducing orselling the subject products, and we may determine to devote our resources to different products.Changes in government regulations could increase our costs and could require us to undergo additional trials or procedures, or could make it impractical orimpossible for us to market our products for certain uses, in certain markets, or at all.17 Table of ContentsChanges in government regulations may adversely affect our financial condition and results of operations because we may have to incur additional expensesif we are required to change or implement new testing, manufacturing and control procedures. If we are required to devote resources to develop such newprocedures, we may not have sufficient resources to devote to research and development, marketing, or other activities that are critical to our business.We can manufacture and sell our products only if we comply with regulations and quality standards established by government agencies such as the FDA andthe U.S. Department of Agriculture as well as by non-governmental organizations such as the ISO and WHO. We have implemented a quality control systemthat is intended to comply with applicable regulations. Although FDA approval is not required for the export of our products, there are export regulationspromulgated by the FDA that specifically relate to the export of our products that require compliance with FDA QSRs and that also require meeting certaindocumentary requirements regarding the approval of the product in export markets. If We do not Comply with FDA or Other Regulatory Requirements, We may be Required to Suspend Production or Sale of Our Products or Institute aRecall, which could Result in Higher Costs and a Loss of Revenues.Regulations of the FDA and other federal, state and foreign regulatory agencies have significant effects on many aspects of our operations, and the operationsof our suppliers and distributors, including packaging, labeling, manufacturing, adverse event reporting, recalls, distribution, storage, advertising, promotionand record keeping. We are subject to routine inspection by the FDA and other agencies to determine compliance with QSRs and FDA regulatoryrequirements in the United States and other applicable regulations worldwide, including but not limited to ISO standards. We believe that our facilities andprocedures are in material compliance with the FDA requirements and ISO standards, but the regulations may be unclear and are subject to change, and wecannot be sure that the FDA or other regulators will agree with our compliance with these requirements. The FDA and foreign regulatory agencies may requirepost-marketing testing and surveillance to monitor the performance of approved or cleared products or impose conditions on any product clearances orapprovals that could restrict the distribution or commercial applications of those products. Regulatory agencies may impose restrictions on our or ourdistributors’ advertising and promotional activities or preclude these activities altogether if a noncompliance is believed to exist. In addition, the subsequentdiscovery of previously unknown problems with a product may result in restrictions on the product or additional regulatory actions, including withdrawal ofthe product from the market.Our inability to comply with the applicable requirements of the FDA can result in, among other things, 483 notices, warning letters, administrative orjudicially imposed sanctions such as injunctions, recall or seizure of products, civil penalties, withdrawal of product registrations, total or partial suspensionof production, refusal to grant premarket clearance or PMA approval for devices, marketing clearances or approvals, or criminal prosecution. The ability ofour suppliers to supply critical components or materials and of our distributors to sell our products could also be adversely affected if their operations aredetermined to be out of compliance. Such actions by the FDA and other regulatory bodies could adversely affect our revenues, costs and results of operations.We must frequently make judgment decisions with respect to compliance with applicable laws and regulations. If regulators subsequently disagree with howwe have sought to comply with these regulations, we could be subjected to substantial civil and criminal penalties, as well as product recall, seizure orinjunction with respect to the sale of our products. Our reputation could be substantially impaired if we are assessed any civil and criminal penalties and limitour ability to manufacture and market our products which could have a material adverse effect on our business.Our Inability to Respond to Changes in Regulatory Requirements could Adversely Affect Our Business.We believe that our products and procedures are in material compliance with all applicable FDA regulations, ISO requirements, and other applicableregulatory requirements, but the regulations regarding the manufacture and sale of our products, the QSR and ISO requirements, and other requirements maybe unclear and are subject to change. Newly promulgated regulations could require changes to our products, necessitate additional clinical trials orprocedures, or make it impractical or impossible for us to market our products for certain uses, in certain markets, or at all. The FDA and other regulatoryauthorities also have the ability to change the requirements for obtaining product approval and/or impose new or additional requirements as part of theapproval process. These changes or new or additional requirements may occur after the completion of substantial clinical work and other costly developmentactivities. The implementation of such changes or new or additional requirements may result in additional clinical trials and substantial additional costs andcould delay or make it more difficult or complicated to obtain approvals and sell our products. In addition, the FDA may revoke an Emergency UseAuthorization under which our products are sold, where it is determined that the underlying health emergency no longer exists or warrants suchauthorization. Such revocation would preclude the sale of our affected products unless and until a further regulatory approval or authorization is obtained.We cannot predict the effect, if any, that these changes might have on our business, financial condition or results of operations.Demand for Our Products may be Affected by FDA Regulation of Laboratory-Developed Tests and Genetic Testing.Regulatory responsibility over instruments, test kits, reagents and other devices used to perform diagnostic testing by clinical laboratories is covered by theFDA. The FDA has previously taken the position that it has regulatory authority over laboratory-developed tests, or LDTs, but has exercised enforcementdiscretion by not regulating most LDTs performed by high complexity CLIA-certified laboratories. LDTs are tests designed, developed, and performed in-house by a laboratory. These laboratories are subject to CLIA regulation but such laboratories have previously not been subject to regulation by FDA underthe agency’s medical device requirements.However, the FDA has announced that it would begin regulating LDTs, and in October 2014 the FDA issued proposed guidance on the regulation of LDTs forpublic comment. But, on November 18, 2016, the FDA announced that it would not finalize the proposed guidance prior to the end of the Obamaadministration. On January 13, 2017, the FDA released a discussion paper synthesizing public comments on the 2014 draft guidance documents andoutlining a possible approach to regulation of LDTs. The discussion paper has no legal status and does not represent a final version of the LDT draft guidancedocuments. We cannot predict what policies the Trump administration will adopt with respect to LDTs. If the FDA increases regulation of LDTs, it couldmake it more difficult for laboratories and other customers to continue offering LDTs that involve genetic or molecular testing. This, in turn, could reducedemand for our products and adversely impact our revenues.In Addition to FDA Requirements, We Are Subject to Several Government Regulations, Compliance with which could Increase Our Costs and AffectOur Operations.In addition to the FDA regulations previously described, laws and regulations in some states may restrict our ability to sell products in those states.We must comply with numerous laws related to safe working conditions, environmental protection, disposal of hazardous substances, fire hazard control,manufacturing practices and labor or employment practices. Compliance with these laws or any new or changed laws regulating our business could result insubstantial costs. Due to the number of laws and regulations governing our industry, and the actions of a number of government agencies that could affect ouroperations, it is impossible to reliably predict the full nature and impact of these laws and regulations. To the extent the costs and procedures associated withcomplying with these laws and requirements are substantial or it is determined that we do not comply, our business and results of operations could beadversely affected.We may Incur Additional Costs if We do not Comply with Privacy, Security and Breach Notification Regulations.We believe that we are not a covered entity nor a business associate of a covered entity and are not responsible for complying with the Health InsurancePortability and Accountability Act of 1996, or HIPAA. Even though we likely are not a covered entity under HIPAA, we do have in place administrative,technical and physical safeguards to protect the privacy and security of consumers’ personal information.] We are required to comply with varying stateprivacy, security and breach reporting laws. If we fail to comply with existing or new laws and regulations related to properly transferring data containingconsumers’ personal information, we could be subject to monetary fines, civil penalties or criminal sanctions. Also, there are other federal and state laws thatprotect the privacy and security of consumers’ personal information, and we may be subject to enforcement by various governmental authorities and courtsresulting in complex compliance issues. We could incur damages under state laws pursuant to an action brought by a private party for the wrongful use ordisclosure of consumers’ personal information.Failure to Comply With Recent European Data Protection Requirements could Increase Our Costs.The EU has adopted a comprehensive overhaul of its data protection regime from the prior national legislative approach to a single European Economic AreaPrivacy Regulation called the General Data Protection Regulation, or GDPR, which came into effect on May 25, 2018. The new EU data protection regimeextends the scope of the EU data protection law to all foreign companies processing data of EU residents. It imposes a strict data protection complianceregime with severe penalties of up to the greater of 4% of worldwide turnover and €20 million and includes new rights such as the “portability” of personaldata. Although the GDPR will apply across the EU without a need for local implementing legislation, as had been the case under the prior data protectionregime, local data protection authorities will still have the ability to interpret the GDPR, which has the potential to create inconsistencies on a country-by-country basis. We are evaluating these new requirements and implementing a plan to ensure compliance. Complying with the enhanced obligations imposedby the GDPR may result in significant costs to our business and require us to amend certain of our business practices. Further, we have no assurances thatviolations will not occur, particularly given the complexity of the GDPR, as well as the uncertainties that accompany new, comprehensive legislation.18 Table of ContentsIf We are not Able to Manufacture Products in Accordance with Applicable Requirements, It could Adversely Affect Our Business.Our products must meet detailed specifications, performance standards and quality requirements. As a result, our products and the materials used in theirmanufacture or assembly undergo regular inspections and quality testing. Factors such as defective materials or processes, mechanical failures, human errors,environmental conditions, changes in materials or production methods, and other events or conditions could cause our products or the materials used toproduce or assemble our products to fail inspections and quality testing or otherwise not perform in accordance with our label claims or the expectations ofour customers.If we are not able to meet the applicable specifications, performance standards, quality requirements or customer expectations could adversely affect ourability to manufacture and sell our products or comply with regulatory requirements. These events could, in turn, adversely affect our revenues and results ofoperations.Healthcare Fraud and Abuse Laws Could Adversely Affect Our Business and Results of Operations.There are various federal and state laws targeting fraud and abuse in the healthcare industry to which we are subject, including anti-kickback laws, lawsconstraining the sales, false claims laws, marketing and promotion of medical devices by limiting the kinds of financial arrangements that manufacturers ofthese products may enter into with physicians, hospitals, laboratories and other potential purchasers of medical devices. There are other laws we are subject tothat require us to report certain transactions between it and healthcare professionals. Violations of these laws are punishable by criminal or civil sanctions,including substantial fines, imprisonment and exclusion from participation in government healthcare programs. Many of the existing requirements are newand have not been definitively interpreted by state authorities or courts, and available guidance is limited. We could face enforcement action and fines andother penalties, and could receive adverse publicity, unless and until we are in full compliance with these laws, all of which could materially harm us.Furthermore, changes in or evolving interpretations of these laws, regulations, or administrative or judicial interpretations, may require us to change ourbusiness practices or subject our business practices to legal challenges, which could have a material adverse effect on our business, financial condition andresults of operations.Our Compliance with Regulations Governing Public Companies is Complex and Expensive.Public companies are subject to various laws and regulations, which have increased the scope, complexity and cost of corporate governance, reporting anddisclosure practices. For example, we are subject to the Sarbanes-Oxley Act of 2002, The Dodd-Frank Wall Street Reform and Consumer Protection Act andthe requirements of The NASDAQ Global Market. The implementation of certain aspects of these laws and regulations has required and will continue torequire substantial management time and oversight and may require us to incur significant additional accounting and legal costs. We continually reviewchanges with respect to new and proposed rules and cannot predict or estimate the amount of additional costs, and the timing of such costs, we may incur.There are several interpretations of these laws and regulations, in many cases due to their lack of specificity, and as a result, their application in practice maychange as new guidance is provided by regulatory and governing bodies. This may result in continuing uncertainty regarding compliance matters and highercosts. We are committed to maintaining high standards of corporate governance and public disclosure, but if we fail to comply with any of theserequirements, legal proceedings may be initiated against us, which may adversely affect our business.Risks Related to Our Common StockOur Common Stock has Limited Liquidity, and Investors may not be Able to Sell as Much Stock as They Want at Prevailing Market Prices or at all.The liquidity of our Common Stock depends on several factors, including but not limited to our financial results and overall market conditions, so it is notpossible to predict whether this level of liquidity will continue, be sustained, or decrease. Decreased trading volume in our stock would make it more difficultfor investors to sell their shares in the public market at any given time at prevailing prices. Our management and larger stockholders exercise significantcontrol over our company.The Price of Our Common Stock could Continue to be Volatile.The price of our Common Stock has been volatile and may be volatile in the future. The following factors, among others, could have a significant impact onthe market for our Common Stock: (1) the performance of our business; (2) clinical results with respect to our products or those of our competitors; (3) thegain or loss of significant contracts and availability of funding for the purchase of our products; (4) actions undertaken by the Congress or the PresidentialAdministration; (5) changes in our relations with our key customers, distributors or suppliers; (6) developments in patent or other proprietary rights; (7)litigation or threatened litigation; (8) general market and economic conditions; (9) the relatively low trading volume for our Common Stock; (10) changes incompetition; (11) Complaints or concerns about the performance or safety of our products and publicity about those issues, including publicity expressedthrough social media or otherwise over the internet; (12) failure to achieve, or changes in, financial estimates by securities analysts and comments or opinionsabout us by securities analysts or major stockholders; (13) announcement of regulatory or enforcement actions by the FDA or other agencies against us, ourproducts or our customers; (14) changes in our operating results; and (15) terrorist attacks, civil unrest, war and national disasters.19 Table of ContentsOverall, the stock market has experienced price and volume fluctuations that have affected the market price of our Common Stock, as well as the stock ofmany other similar companies. Such price fluctuations are generally unrelated to the operating performance of the specific companies whose stock is affected.After the volatility in the market price of a company’s stock, class action litigation has occurred against the issuing company. If we were subject to this typeof litigation in the future, we could incur substantial costs and the attention and resources of our management could be diverted, each of which could have amaterial adverse effect on our revenue and earnings. Any adverse determination in this type of litigation could also subject us to significant liabilities.Sales of Our Common Stock by Existing Stockholders, Executive Officers or Directors could Depress the Market Price of Our Common Stock.If our existing stockholders, officers or directors sell our Common Stock in the public market, or the perception that such sales may occur, it could negativelyaffect the price of our Common Stock. We are unable to estimate the number of shares of our Common Stock that may actually be resold in the public marketsince this will depend on the market price for our Common Stock, the individual circumstances of the sellers and other factors.Institutional stockholders own significant amounts of our Common Stock. If one or more of these stockholders sell large portions of their holdings in arelatively short time, the prevailing price of our Common Stock could be negatively affected. In addition, it is possible that one or more of our executiveofficers or non-employee members of our Board of Directors could sell shares of our Common Stock during an open trading window. These transactions andthe perceived reasons for these transactions could have a negative effect on the prevailing market price of our Common Stock.We do not Intend to Pay Cash Dividends on Our Common Stock.We do not expect to pay any cash dividends on our Common Stock and currently intend to retain our earnings, if any, to finance the expansion of ourbusiness. Therefore, the success of an investment in our Common Stock will depend entirely upon any future increase in value of our Common Stock. Thereis no guarantee that our Common Stock will gain value or even maintain the price at which investors purchased their shares.If We or Our Independent Registered Public Accounting Firm Concludes That Our Internal Control Over Financial Reporting is Not Effective, InvestorConfidence and the Value of Our Common Stock May be Adversely Impacted.The SEC has adopted rules requiring us, as a public company, to include a report in our Annual Reports on Form 10-K that contains an assessment bymanagement of the effectiveness of our internal control over financial reporting. In addition, our independent registered public accounting firm must reporton the effectiveness of these internal controls.We believe our internal controls will continue to evolve as our business develops. We continue to review our internal control over financial reporting in aneffort to ensure compliance with SEC rules and regulations, any control system, regardless of how well designed and operated, can provide only reasonableassurance that its objectives will be met. In addition, the overall quality of our internal controls may be affected by the internal control over financialreporting implemented by any business we acquire and our ability to assess and successfully integrate the internal controls of any such business.If our independent registered public accounting firm is not satisfied with our internal control over financial reporting or the level at which our controls aredocumented, designed, implemented, or tested, or if the independent registered public accounting firm interprets the requirements, rules or regulationsdifferently than we do, then it may issue a report noting such dissatisfaction. We also could conclude that our internal control over financial reporting is noteffective. These events could result in an adverse reaction in the financial marketplace, which ultimately could negatively impact the market price of ourCommon Stock.Any Future Issuances of Shares of Our Common Stock by Us Could Harm the Price of Our Common Stock and Our Ability to Raise Funds in NewEquity Offerings.Any future sales of a substantial number of our shares of Common Stock or other equity-related securities, or the perception that such sales may occur, couldadversely affect the price of our Common Stock, and could impair our ability to raise capital through future offerings of equity or equity-related securities. Our Management and Larger Stockholders Exercise Significant Control Over Us.As of December 31, 2018, our named executive officers, directors and 5% stockholders beneficially owned approximately 14.21% of our voting power, whichincludes 1 large investor that beneficially owns approximately 8.73%, of the outstanding stock. For the foreseeable future, and assuming these ownershippercentages continue to apply, to the extent that these parties vote similarly, they may be able to exercise significant control over many matters requiringapproval by the board of directors or our stockholders. As a result, they may be able to:• control the composition of our board of directors;• control our management and policies;• determine the outcome of significant corporate transactions, including changes in control that may be beneficial to stockholders; and,• act in each of their own interests, which may conflict with or differ from the interests of each other or the interests of the other stockholders.20 Table of ContentsITEM 2.PROPERTIESOur corporate headquarters and U.S. manufacturing, administrative offices, and research facilities are located in leased space in Medford, New York, pursuantto a lease covering approximately 39,650 square feet and expiring on April 30, 2019. We also lease nearby warehouse space and additional administrativeoffices in Holbrook, New York, pursuant to a lease covering approximately 21,700 square feet and expiring on April 30, 2020.On February 5, 2019, we entered into a commercial real estate lease for new corporate headquarters comprised of 70,000 square feet of office, research anddevelopment, and warehouse space located at 555 Wireless Boulevard, Hauppauge, New York. The lease has an initial term of eleven years that can beextended, at our option, for two additional terms of five years each. Rent under the lease, which is payable in monthly installments, totals approximately$900,000 for the initial year and then increases by approximately three percent each succeeding year.On February 5, 2019, we also entered into an agreement to sublet the space at Holbrook, New York. The sublease has a term that will (a) commence on thedate we vacate the premises and (b) terminate on April 29, 2020. The sublessee will pay us 50% of our rent and additional rent payments, which will totalapproximately $100,000 per year during the term of the sublease.Our European headquarters and Center of Excellence for Optical Technology is located in leased office and manufacturing space in Berlin, Germany. OurSoutheast Asia manufacturing, warehouse, and commercial facilities are located in leased space in Kuala Lumpur, Malaysia. We regularly review our realestate portfolio and develop footprint strategies to support our customers’ global plans, while at the same time supporting our technical needs and controllingoperating expenses.ITEM 3.LEGAL PROCEEDINGSFrom time to time we may become involved in legal proceedings or may be subject to claims arising in the ordinary course of our business. Although theresults of litigation and claims cannot be predicted with certainty, we currently believe that the final outcome of these ordinary course matters will not have amaterial adverse effect on our business, operating results, financial condition or cash flows. Regardless of the outcome, litigation can have an adverse impacton us because of defense and settlement costs, diversion of management resources and other factors.21 Table of ContentsPART II ITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITYSECURITIES Listing Information Our stock is listed on the NASDAQ Global Select Market of the NASDAQ Stock Market LLC under the symbol “CEMI.” Holders As of March 1, 2019, there were 132 record owners of our Common Stock (including nominee holders such as banks and brokerage firms who hold shares forbeneficial owners). Recent Sales of Unregistered Securities There were no sales of unregistered securities during the quarter ended December 31, 2018.Issuer Purchases of Equity Securities We did not repurchase any of our equity securities during the quarter ended December 31, 2018.22 Table of ContentsITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis should be read in conjunction with the audited consolidated financial statements and related notes included in thisreport. In addition to historical information, the following discussion contains forward-looking statements that involves risks, uncertainties andassumptions. See “Special Note Regarding Forward-Looking Statements” at page [2] of this report. Please read “Item1A. Risk Factors” for a discussion offactors that could cause our actual results to differ materially from our expectations.The following discussion is presented in six sections:• Executive Overview• Consolidated Results of Operations• Liquidity and Capital Resources• Recent Developments• Significant Accounting Policies and Critical Accounting Estimates• Recently Issued Accounting PronouncementsExecutive Overview Through our wholly owned subsidiaries, Chembio Diagnostic Systems Inc., Chembio Diagnostics Malaysia Sdn Bhd and opTricon, we develop, manufactureand commercialize point-of-care diagnostic tests that are used to detect or diagnose diseases. All products that are currently being developed are based on ourpatented DPP technology, a novel point-of-care diagnostic platform that offers certain customer advantages as compared to traditional lateral flowtechnology. Chembio was formed in 1985.Recent operational accomplishments and highlights include:• Achieved total revenue of $33.4 million for full year 2018, an increase of 39% over prior year• Achieved product sales of $26.7 million for full year 2018, also an increase of 38% over prior year• Acquired opTricon, a developer and manufacturer of hand-held analyzers that when used in combination with our DPP tests, provide quantitativeresults• Advanced technology collaborations with AstraZeneca, Lumira Dx, FIND and others• Purchased a fully-automated DPP test manufacturing line• Hosted analyst and investor day and introducing five-year targets for $100 million of revenue in 2023 and 50% gross margins for year end 2023We strengthened our balance sheet from underwritten public offerings that generated net proceeds of $10.9 million in February 2018 and $16.5 million inNovember 2018. See “—Recent Developments.”Our product commercialization and product development efforts are focused in two areas: infectious diseases (which includes both sexually transmitteddisease and tropical/fever disease) and technology collaborations. In infectious disease, we are commercializing tests for HIV and Syphilis. In tropical andfever disease, we are commercializing tests for dengue virus, Zika virus, chikungunya virus, and ebola virus, individually or as part of an advanced multiplextest. We are also developing tests for lassa, Marburg, malaria, leptospirosis, Rickettsia typhi, Burkholderia pseudomallei, and Orientia tsutsugamushi,individually or as part of a fever panel test, and hepatitis C. Through technology collaborations, we are developing tests for a specific form of cancer,concussion, bovine tuberculosis, and for eosinophilic respiratory disease, the latter in collaboration with global biopharmaceutical company AstraZeneca.Large and growing markets have been established for these kinds of tests, initially in high prevalence regions where they are indispensable for large scaleprevention and treatment programs. Our product development is focused on areas where the availability of rapid point-of-care screening, diagnostic, orconfirmatory results can improve health outcomes. More generally, we believe there is and will continue to be a growing demand for diagnostic productsthat can provide accurate, actionable diagnostic information in a rapid, cost-effective manner at the point of care.Our products are sold to medical laboratories and hospitals, governmental and public health entities, non-governmental organizations, medical professionalsand retail establishments, both domestically and internationally, under our STAT-PAK, SURE CHECK, STAT-VIEW or DPP registered trademarks, or underthe private labels of our marketing partners. Consolidated Results of OperationsThe results of operations for the years ended December 31, 2018 and 2017 were as follows: Year Ended December 31, 2018 2017 TOTAL REVENUES $33,409,251 100% $24,015,427 100% COSTS AND EXPENSES: Cost of product sales 21,427,243 64% 12,921,157 54%Research and development expenses 8,526,256 26% 8,555,381 36%Selling, general and administrative expenses 11,100,775 33% 8,963,363 37%Acquisition costs 337,645 1% 58,076 0% 41,391,919 124% 30,497,977 127%LOSS FROM OPERATIONS (7,982,668) (24)% (6,482,550) (27)% OTHER INCOME 49,498 0% 22,485 0% LOSS BEFORE INCOME TAXES (7,933,170) (24)% (6,460,065) (27)% Income tax (benefit) provision (67,521) 0% (88,305) 0%NET LOSS $(7,865,649) (24)% $(6,371,760) (27)%Percentages in the table reflect the percent of total revenues.23 Table of ContentsTotal Net Revenues Total net revenues during the year ended December 31, 2018 were $33.4 million, an increase of $9.4 million, or 39% compared to 2017. The increase in totalnet revenues was comprised of the following:• $7.4 million, or 38% increase in net product sales, reflecting gains in Africa, Latin America, and Europe. Africa benefited from or winning the singlelargest tender in our history for the supply of HIV tests to Ethiopia, together with meaningful commercial successes in other countries. Latin Americagains reflect continued growth in Brazil, and Europe reflects the increasing trend of HIV self-testing. As part of these regional successes and ashighlighted above, during November 2018, we completed the acquisition of opTricon. Refer to Note 2 – Acquisition to the audited consolidatedfinancial statements included herein for further information regarding the acquisition.• $2.0 million, or 42% increase in R&D and grant, and license and royalty revenues compared to 2017, reflecting our continued success in securinggovernmental, non-governmental, and commercial partnerships, in particular associated with our DPP technology platform.Gross Product MarginCost of product sales is primarily comprised of material, labor, manufacturing overhead, depreciation and amortization, and other operating expenses. Grossproduct margin is net product sales less cost of product sales, and gross product margin percentage is gross product margin as a percentage of net productsales.Gross product margin decreased by $1.1 million, or 17% compared to 2017. The following schedule calculates gross product margin: For the years ended December 31, 2018 December 31, 2017 Favorable/(unfavorable) % Change (in thousands) Net product sales $26,741 $19,322 $7,419 38.4%Less: Cost of product sales (21,427) (12,921) (8,506) 65.8%Gross product margin $5,314 $6,401 $(1,087) (17.0)%Gross product margin % 19.9% 33.1% The $1.1 million decrease in gross product margin was comprised of the following:• $2.4 million from favorable product sales volume as described above, and• $3.5 million from unfavorable product margins, related to increased labor (including contract labor) to manually assemble our products and theimpact of geographic mix on average selling prices.Research and DevelopmentThis category includes costs incurred for clinical and regulatory affairs and other research and development, as follows: For the years ended December 31, 2018 December 31, 2017 Favorable/(unfavorable) % Change (in thousands) Clinical and regulatory affairs $1,307 $2,298 $991 43.1%Other research and development 7,219 6,257 (962) (15.4)% Total research and development $8,526 $8,555 $29 0.3%The decrease in clinical & regulatory affairs costs for 2018 as compared to 2017 is primarily associated with our U.S. clinical trial evaluating our DPP HIV-Syphilis System, which we completed in December 2017. The increase in other research and development costs is primarily associated with spendingassociated with the 45% increase in revenue from externally-funded research and development projects.Selling, General and Administrative ExpenseSelling, general and administrative expense includes administrative expenses, sales and marketing costs including commissions, and other corporate items.The $2.1 million, or 23.8%, increase in selling, general and administrative expenses for the year ended December 31, 2018 as compared to 2017 is associatedwith increased personnel, sales commissions, and non-cash equity compensation expenses.Acquisition CostsAcquisition costs include legal, due diligence, audit, and related costs associated with acquisitions. The $0.3 million, or 481.4% increase in acquisition costsfor the year ended December 31, 2018 as compared to 2017 is associated with spending related to the acquisition of opTricon in November 2018. The 2017costs relate to completion of the acquisition of RVR Diagnostics in January 2017.Other Income and ExpenseOther income and expenses are principally interest income earned on our deposits, net of interest expense, which increased by approximately $27,000 for2018 as compared to 2017.Income Tax ProvisionFor 2018 we recognized a tax benefit of $67,521 primarily attributable to the loss generated by Chembio Diagnostics Malaysia. As of December 31, 2018 and2017, our deferred tax assets include a full valuation allowance against our deferred tax assets.24 Table of ContentsLiquidity and Capital ResourcesDuring the year ended December 31, 2018, we funded our business operations, including capital expenditures and working capital requirements, principallyfrom $27.5 million of net proceeds from two underwritten public offerings and $3.0 million of non-exchange transaction awards from research anddevelopment programs. Our operations used cash flow of $11.8 million. As of December 31, 2018, we had no outstanding debt other than a $0.4 millionseller-financed note payable incurred in connection with our purchase of automated manufacturing equipment.We believe our existing cash and cash equivalents and our cash flow from operating activities will be sufficient to meet our anticipated cash needs for at leastthe next twelve months. Our future working capital needs will depend on many factors, including the rate of our business and revenue growth, the timing ofour automation of U.S. manufacturing, and the timing of investment in our research and development as well as sales and marketing.If we are unable to increase our revenues and manage our expenses in accordance with our operating plan, we may not be able to generate the cash flowneeded to fund our automation of U.S. manufacturing and our investment in research and development and sales and marketing at the time contemplated byour operating plan. In such an event, we may elect to reduce the level, or otherwise delay the timing, of such funding and/or such investments, which wouldlikely curtail or delay the growth in our business contemplated by our operating plan and could impair or defer our ability to achieve profitability andgenerate cash flow.If we do not elect to reduce or delay such funding and/or investments, or if we determine to effect one or more acquisitions of businesses, technologies orproducts, we may be required to seek to raise additional funds through public or private financings, strategic relationships, or other arrangements, to theextent funding would be available to us on acceptable terms or at all. If we were to raise additional funds through the issuance of equity or convertiblesecurities, the issuance could result in substantial dilution to existing stockholders, and the holders of these new securities or debt may have rights,preferences and privileges senior to those of the holders of our Common Stock.Sources of FundsEquity and Equity-Related Securities. We received net proceeds of $10.9 million from an underwritten public offering of Common Stock in February 2018and $16.5 million from an underwritten public offering of Common Stock in November 2018. We do not expect to raise additional capital from a publicoffering of Common Stock in 2019.Research and Development Awards. We frequently seek research and development programs that may be awarded by government, non-governmentalorganizations, and non-profit entities, including private foundations.Since 2015 we have earned over $10.8 million of funding from some of the world’s leading health organizations, which has helped us accelerate theexpansion of our pipeline of infectious disease tests. Our collaborators have included Bill & Melinda Gates Foundation, The Paul G. Allen FamilyFoundation, FIOCRUZ and FIND, as well as U.S. government agencies such as CDC, BARDA and the U.S. Department of Agriculture. See “Item 1. Business—Products” above. During the year ended December 31, 2018, we recognized grant revenue totaling $3.0 from government, non-governmental organizations,and non-profit entities.Working Capital. The following table sets forth selected working capital information: December 31, 2018 (in thousands) Cash and cash equivalents $12,525 Accounts receivable, net of allowance for doubtful amounts 7,374 Inventories, net 7,851 Prepaid expenses and other current assets 702 Total current assets 28,452 Less: Total current liabilities (6,519) Working capital $21,933 Our cash and cash equivalents at December 31, 2018 were unrestricted and held for working capital purposes. We currently intend to retain all availablefunds and any future earnings for use in the operation of our business and do not anticipate paying any cash dividends. We have not entered into, and do notexpect to enter into, investments for trading or speculative purposes. Our accounts receivable balance fluctuates from period to period, which affects our cashflow from operating activities. Fluctuations vary depending on cash collections, client mix, and the timing of shipment of our products and the invoicing ofour research and development activities.Uses of FundsCash Flow Used in Operating Activities. Our operations used $11.8 million of cash during the year ended December 31, 2018, primarily due to the net lossadjusted for non-cash items of $6.4 million, a $5.2 million increase in accounts receivable related to the 39% increase in total revenue, and a $3.1 millionincrease in inventory, offset by a $2.6 million increase in accounts payable and accrued liabilities.Acquisition. In November 2018, we acquired all of the equity interests of opTricon for a purchase price of $5.5 million in cash, of which (a) $100,000 wasdeposited in escrow for a potential purchase price adjustment based on the working capital of opTricon and (b) $750,000 was deposited in escrow to satisfycertain claims that we may make against the sellers in accordance with the terms of the related purchase agreement. See “—Recent Developments” below.Capital Expenditures. During the year ended December 31, 2018, we continued to invest in manufacturing equipment and other fixed assets. Our capitalexpenditures totaled $1.5 million in 2018.25 Table of ContentsEffects of InflationInflation and changing prices have not had a material effect on our business, and we do not expect that they will materially affect our business in theforeseeable future. Any impact of inflation on cost of revenue and operating expenses, especially employee compensation costs, may not be readilyrecoverable in the price of our product offerings.Off-Balance Sheet ArrangementsWe do not have any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of Regulation S-K under the Securities Exchange Act of 1934.Recent DevelopmentsOn November 5, 2018, we consummated an underwritten registered public offering of 2,726,000 shares of our Common Stock, including the underwriter'sentire overallotment option of 355,565 shares, at a public offering price of $6.75 per share, for gross proceeds of approximately $18.4 million. The netproceeds, after underwriting discounts and commissions, and estimated expenses, were approximately $16.5 million.On November 6, 2018, we acquired opTricon pursuant to a share purchase agreement dated October 17, 2018. Under the terms of the purchase agreement, weacquired all of the outstanding equity shares of opTricon for a purchase price of $5.5 million in cash, of which (a) $100,000 was deposited in escrow for apotential purchase price adjustment based on the working capital of opTricon and (b) $750,000 was deposited in escrow to satisfy certain claims that we maymake against the sellers in accordance with the terms of the purchase agreement.In accordance with the purchase agreement, each of Lutz Melchior and Volker Plickert, the founders of opTricon, entered into a managing director servicesagreement pursuant to which they agreed, among other things, to serve as employees of opTricon through November 5, 2021.opTricon, which is based in Berlin, Germany, is a developer and manufacturer of handheld analyzers for rapid diagnostic tests. Since 2015 we and opTriconhave been parties to an agreement under which we have collaborated in developing our DPP Micro Reader, a handheld, battery-operated analyzer that uses aninnovative image sensor to provide, when combined with our DPP tests, a quantitative interpretation of diagnostic results. opTricon will become a ChembioCenter-of-Excellence for optical technology and will serve as our European headquarters. As part of its ongoing business, opTricon will continue to developand manufacture handheld analyzers for original equipment manufacturers that do not compete with us. The DPP Micro Reader is included in most of ournew product development initiatives and regulatory approvals and submissions. As a result of the acquisition, we secured global commercial rights toopTricon’s offerings and technology and will be able to produce DPP Micro Readers at a reduced cost, which we believe will enable us to promote DPP testsand DPP Micro Readers more actively across global markets. We cannot assure you that we will achieve the intended benefits from the opTricon acquisition.Significant Accounting Policies and Critical Accounting EstimatesOur significant accounting policies are described in Note 3 – Significant Accounting Policies to the audited consolidated financial statements includedherein. Certain of our accounting policies require the application of significant judgment by management in selecting the appropriate assumptions forcalculating financial estimates. By their nature, these judgments are subject to an inherent degree of uncertainty. These judgments are based on our historicalexperience, terms of existing contracts, our evaluation of trends in the industry, information provided by our customers and information available from otheroutside sources, as appropriate. We consider an accounting estimate to be critical if:• It requires us to make assumptions about matters that were uncertain at the time we were making the estimate, and• Changes in the estimate or different estimates that we could have selected would have had a material impact on our financial condition or results ofoperations.The following listing is not intended to be a comprehensive list of all of our accounting policies. In many cases, the accounting treatment of a particulartransaction is specifically dictated by accounting principles generally accepted in the United States, with no need for management’s judgment in theirapplication. There are also areas in which management’s judgment in selecting any viable alternative would not produce a materially different result. Revenue RecognitionWe recognize revenue for product sales in accordance with FASB ASC 606, Revenue from Contracts with Customers. Revenues from product sales arerecognized when the customer obtains control of our product, which occurs at a point in time, typically upon tendering to the customer. We expenseincremental costs of obtaining a contract as and when incurred because the expected amortization period of the asset that it would have recognized is oneyear or less or the amount is immaterial. Freight and distribution activities on products are performed after the customer obtains control of the goods. We havemade an accounting policy election to account for shipping and handling activities that occur either when or after goods are tendered to the customer as afulfillment activity, and therefore recognizes freight and distribution expenses in Cost of Product Sales.For certain contracts, we recognize revenue from research and development, milestone and grant revenues when earned. Grants are invoiced after expensesare incurred. Revenues from projects or grants funded in advance are deferred until earned. For certain collaborative research projects, we recognize revenueby defining milestones at the inception of the agreement and applying judgement and estimates in recognizing revenue for relevant contracts.Stock-Based CompensationWe recognize the fair value of equity-based awards as compensation expense in our statement of operations. The fair value of restricted stock and restrictedstock unit awards are their fair value on the date of grant. The fair value of our stock option awards was estimated using a Black-Scholes option valuationmodel. This valuation model’s computations incorporate highly subjective assumptions, such as the expected stock price volatility and the estimated life ofeach award. The fair value of equity-based awards, after considering the effect of expected forfeitures, is then amortized, generally on a straight-line basis,over the related vesting period of the option.Research and Development CostsResearch and development activities consist primarily of new product development, continuing engineering for existing products, and regulatory andclinical trial costs. Costs related to research and development efforts on existing or potential products are expensed as incurred.26 Table of ContentsInventoriesInventories are stated at the lower of cost and net realizable value, using the first-in, first-out method, or FIFO, to determine cost. Our policy is to periodicallyevaluate the market value of the inventory and the stage of product life cycle, and record a reserve for any inventory considered slow moving or obsolete. Forexample, each additional 1% of obsolete inventory would reduce such inventory by approximately $78,000.Accounts ReceivableOur policy is to review our accounts receivable on a periodic basis, no less frequently than monthly. On a quarterly basis an analysis is made of the adequacyof our allowance for doubtful accounts and adjustments are made accordingly. The current allowance is approximately 0.6% of accounts receivable. Forexample, each additional 1% of accounts receivable that becomes uncollectible would reduce such balance of accounts receivable by approximately$74,000.AcquisitionsIn accordance with accounting guidance for the provisions in FASB ASC 805, Business Combinations, we allocate the purchase price of an acquired businessto its identifiable assets and liabilities based on estimated fair values. The excess of the purchase price over the amount allocated to the assets and liabilities,if any, is recorded as goodwill. In addition, an acquisition may include a contingent consideration component. The fair value of the contingent considerationis estimated as of the date of the acquisition and is recorded as part of the purchase price. This estimate is updated in future periods and any changes in theestimate, which are not considered an adjustment to the purchase price, are recorded in our consolidated statements of operations.We use all available information to estimate fair values. We typically engage outside appraisal firms to assist in the fair value determination of identifiableintangible assets and any other significant assets or liabilities. We adjust the preliminary purchase price allocation, as necessary, up to one year after theacquisition closing date as we obtain more information regarding asset valuations and liabilities assumed.Our purchase price allocation methodology contains uncertainties because it requires management to make assumptions and to apply judgment to estimatethe fair value of acquired assets and liabilities. Management estimates the fair value of assets and liabilities based upon quoted market prices, the carryingvalue of the acquired assets and widely accepted valuation techniques, including discounted cash flows and market multiple analyses. Unanticipated eventsor circumstances may occur which could affect the accuracy of our fair value estimates, including assumptions regarding industry economic factors andbusiness strategies.Other estimates used in determining fair value include, but are not limited to, future cash flows or income related to intangibles, market rate assumptions,actuarial assumptions for benefit plans and appropriate discount rates. Our estimates of fair value are based upon assumptions believed to be reasonable, butthat are inherently uncertain, and therefore, may not be realized. Accordingly, there can be no assurance that the estimates, assumptions, and values reflectedin the valuations will be realized, and actual results could vary materially.Goodwill and Intangible AssetsWe periodically review goodwill for impairment indicators. We review goodwill for impairment annually in the fourth quarter or more frequently if events orchanges in circumstances indicate that goodwill might be impaired. We perform the goodwill impairment review at the reporting unit level. We perform aqualitative assessment of whether it is more likely than not that a reporting unit's fair value is less than its carrying amount. If not, no further goodwillimpairment testing is performed. If so, we perform the step discussed hereafter. Our qualitative assessment involves significant estimates, assumptions, andjudgments, including, macroeconomic conditions, industry and market conditions, our financial performance, reporting unit specific events and changes inour share price.If the fair value of the reporting unit is greater than its carrying amount, goodwill is not considered to be impaired. We would recognize an impairmentcharge for the amount by which the carrying amount exceeds the reporting unit’s fair value, provided the impairment charge does not exceed the totalamount of goodwill allocated to the reporting unit. Income TaxesIncome taxes are accounted for under FASB ASC 740, Income Taxes, authoritative guidance, which we refer to as the Guidance and which requires the assetand liability method of accounting for deferred income taxes. Deferred tax assets and liabilities are determined based on the difference between the financialstatement and tax bases of assets and liabilities. Deferred tax assets or liabilities at the end of each period are determined using the tax rate expected to be ineffect when taxes are actually paid or recovered.The Guidance also requires that a valuation allowance be established when it is more likely than not that all or a portion of a deferred tax asset will not berealized. A review of all available positive and negative evidence needs to be considered, including a company’s current and past performance, the marketenvironment in which the company operates, length of carryback and carryforward periods and existing contracts that will result in future profits. The Guidance also prescribes a comprehensive model for recognizing, measuring, presenting and disclosing in the consolidated financial statements taxpositions taken or expected to be taken on a tax return, including a decision whether to file or not to file in a particular jurisdiction.27 Table of ContentsRecently Issued Accounting PronouncementsRefer to Note 3 – Significant Accounting Policies to the audited consolidated financial statements included herein for a complete description of recentaccounting standards which we have not yet been required to implement which may be applicable to our operations. Additionally, the significant accountingstandards that have been adopted during the year ended December 31, 2018 are described.ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAThe Consolidated Financial Statements and schedules that constitute Item 8 are attached at the end of this report. An index to the Consolidated FinancialStatements and schedules is also included on page F-1 of this report.ITEM 9A.Controls and ProceduresEvaluation of Disclosure Controls and ProceduresOur management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosurecontrols and procedures, as defined by Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of December 31, 2018. Based on the evaluation of ourdisclosure controls and procedures, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures wereeffective as of December 31, 2018 at the reasonable assurance level.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financialreporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Securities Exchange Act of 1934 as a process designed by, or under thesupervision of, our principal executive and principal financial officers and effected by the board of directors, management and other personnel to providereasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles and includes those policies and procedures that:• pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of thecompany;• provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generallyaccepted accounting principles, and that receipts and expenditures of the company are being made in accordance with authorizations ofmanagement and directors of the company; and• provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company's assets thatcould have a material effect on the financial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. As a result, even those systemsdetermined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of anyevaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or that the degreeof compliance with the policies or procedures may deteriorate.Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2018. In making this assessment, ourmanagement used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—IntegratedFramework (2013). Based on its assessment, our management believes that, as of December 31, 2018, our internal control over financial reporting waseffective based on those criteria.Previously Identified Material Weaknesses in Internal Control Over Financial ReportingNone.Changes in Internal Control over Financial ReportingThere were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d)of the Securities Exchange Act of 1934 during the period covered by this Annual Report on Form 10-K that materially affected, or are reasonably likely tomaterially affect, our internal control over financial reporting.28 Table of ContentsReport of Independent Registered Public Accounting FirmShareholders and Board of DirectorsChembio Diagnostics, Inc.Medford, New York Opinion on Internal Control over Financial Reporting We have audited Chembio Diagnostics, Inc.’s (the “Company’s”) internal control over financial reporting as of December 31, 2018, based on criteriaestablished in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (the“COSO criteria”). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31,2018, based on the COSO criteria. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the consolidatedbalance sheets of the Company and subsidiaries as of December 31, 2018 and 2017, the related consolidated statements of operations, comprehensive loss,changes in stockholders’ equity, and cash flows for each of the years then ended, and the related notes and our report dated March 18, 2019 expressed anunqualified opinion thereon. Basis for Opinion The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness ofinternal control over financial reporting, included in the accompanying “Item 9A, Management’s Report on Internal Control over Financial Reporting”. Ourresponsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firmregistered with the PCAOB and are required to be independent with respect to the Company in accordance with U.S. federal securities laws and the applicablerules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audit of internal control over financial reporting in accordance with the standards of the PCAOB. Those standards require that we plan andperform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Ouraudit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing andevaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures aswe considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.Definition and Limitations of Internal Control over Financial Reporting A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reportingand the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal controlover financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairlyreflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permitpreparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are beingmade only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention ortimely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation ofeffectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliancewith the policies or procedures may deteriorate./s/ BDO USA, LLP Melville, NYMarch 18, 201929 Table of ContentsPART IIIITEM 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCEThe information required in response to this Item 10 is incorporated herein by reference to our Definitive Proxy Statement to be filed with the SEC pursuantto Regulation 14A of the Exchange Act not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K. ITEM 11.EXECUTIVE COMPENSATIONThe information required in response to this Item 11 is incorporated herein by reference to our Definitive Proxy Statement to be filed with the SEC pursuantto Regulation 14A of the Exchange Act not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K.ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERSThe information required in response to this Item 12 is incorporated herein by reference to our Definitive Proxy Statement to be filed with the SEC pursuantto Regulation 14A of the Exchange Act not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K.ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE. The information required in response to this Item 13 is incorporated herein by reference to our Definitive Proxy Statement to be filed with the SEC pursuantto Regulation 14A of the Exchange Act not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K.ITEM 14.PRINCIPAL ACCOUNTANT FEES AND SERVICES The information required in response to this Item 14 is incorporated herein by reference to our Definitive Proxy Statement to be filed with the SEC pursuantto Regulation 14A of the Exchange Act not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K.30 Table of ContentsITEM 15.EXHIBITS, FINANCIAL STATEMENT SCHEDULES(a) See “Item 8. Financial Statements and Supplementary Data – Index to Consolidated Financial Statements” above.(b) ExhibitsExhibit No. Description 3.1 Articles of Incorporation, as amended, of Chembio Diagnostics, Inc.3.2 Amended and Restated Bylaws, of Chembio Diagnostics, Inc.10.1(a)* 2008 Stock Incentive Plan, as amended10.1(b)* Form of Option for 2008 Stock Incentive Plan10.2(a)* 2014 Stock Incentive Plan10.2(b)* Form of Option for 2014 Stock Incentive Plan10.3* Restated Annual Incentive Bonus Plan of Chembio Diagnostics, Inc., adopted as of March 15, 201910.4* Employment Agreement dated March 13, 2017 between Chembio Diagnostics, Inc. and John J. Sperzel III10.5* Employment Agreement dated March 5, 2016 between Chembio Diagnostics, Inc. and Javan Esfandiari10.6* Employment Agreement dated September 14, 2017 between Chembio Diagnostics, Inc. and Sharon Klugewicz10.7(a)* Employment Agreement dated December 18, 2017 between Chembio Diagnostics, Inc. and Neil A. Goldman10.7(b)* Amendment No. 1 dated January 21, 2019 between Chembio Diagnostics, Inc. and Neil A. Goldman, amending Employment Agreementdated December 18, 201710.8* Offer Letter dated October 19, 2016 between Worldwide Workplace Ireland and Robert Passas, with respect to employment by ChembioDiagnostics Systems, Inc.10.9(a) Lease Agreement, dated February 15, 2017, between Horseblock Associates and Chembio Diagnostics, Inc. with respect to 3661Horseblock Road, Medford, New York, as amended10.9(b) Agreement of Sublease dated February 5, 2019 between Chembio Diagnostic Systems Inc., as sublessor, and Reliance Communications ofNew Jersey, LLC, as sublessee, with respect to 3661 Horseblock Road, Medford, New York, as amended10.10 Lease Agreement, dated February 4, 2013, between Sherwood Corporate Center LLC and Chembio Diagnostics, Inc. with respect to 91-1AColin Drive, Holbrook, New York, as amended on September 19, 201710.11 Lease Agreement dated February 5, 2019 between Myra Properties, LLC, as lessor, and Chembio Diagnostic Systems Inc., as lessee, withrespect to 555 Wireless Boulevard, Hauppauge, New York.10.12 Underwriting Agreement, dated February 9, 2018, between the Registrant and Craig-Hallum Capital Group LLC10.13 Underwriting Agreement dated November 1, 2018 between the Registrant and Craig-Hallum Capital Group LLC14.1 Ethics Policy21.1 List of Subsidiaries of Chembio Diagnostics, Inc.23.1 Consent of BDO USA, LLP, Independent Registered Public Accounting Firm31.1 Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.31.2 Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.32 Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906of the Sarbanes-Oxley Act of 2002101.INS XBRL Instance Document101.SCH XBRL Taxonomy Extension Schema Document101.CAL XBRL Taxonomy Extension Calculation Linkbase Document101.DEF XBRL Taxonomy Definition Linkbase Document101.LAB XBRL Taxonomy Label Linkbase Document101.PRE XBRL Taxonomy Presentation Linkbase Document*Indicates management contract or compensatory plan.31 Table of ContentsSIGNATURES In accordance with Section 13 or 15(d) of the Exchange Act, the registrant has caused this report to be signed on its behalf by the undersigned,thereunto duly authorized. CHEMBIO DIAGNOSTICS, INC. March 18, 2019By /s/ John J. Sperzel John J. Sperzel III Chief Executive Officer and President In accordance with the requirements of the Exchange Act, this report has been signed below by the following persons on behalf of the registrant andin the capacities and on the dates indicated. Signatures Title Date /s/ John J. Sperzel Chief Executive Officer, President and Director March 18, 2019John J. Sperzel III (Principal Executive Officer) /s/ Neil A. Goldman Executive Vice President and Chief Financial Officer March 18, 2019Neil A. Goldman (Principal Financial & Accounting Officer) /s/ Katherine L. Davis Chair of the Board March 18, 2019Katherine L. Davis /s/ Gail S. Page Director March 18, 2019Gail S. Page /s/ Mary Lake Polan Director March 18, 2019Mary Lake Polan /s/ John G. Potthoff Director March 18, 2019 John G. Potthoff 32 Table of ContentsCHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES Index to Consolidated Financial Statements —INDEX— Page(s)Report of Independent Registered Public Accounting FirmF-1 Consolidated Financial Statements: Balance Sheets as of December 31, 2018 and 2017F-2 Statements of Operations for the years ended December 31, 2018 and 2017F-3 Statements of Comprehensive Loss for the years ended December 31, 2018, and 2017F-4 Statements of Changes in Stockholders’ Equity for the years ended December 31, 2018, and 2017F-5 Statements of Cash Flows for the years ended December 31, 2018, and 2017F-6 Notes to Consolidated Financial StatementsF-7 - F-18 Table of ContentsReport of Independent Registered Public Accounting Firm Shareholders and Board of DirectorsChembio Diagnostics, Inc.Medford, New York Opinion on the Consolidated Financial Statements We have audited the accompanying consolidated balance sheets of Chembio Diagnostics, Inc. (the “Company”) and subsidiaries as of December 31, 2018and 2017, the related consolidated statements of operations, comprehensive loss, changes in stockholders’ equity, and cash flows the years then ended, andthe related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, inall material respects, the financial position of the Company and subsidiaries at December 31, 2018 and 2017, and the results of their operations and their cashflows for each of the years then ended, in conformity with accounting principles generally accepted in the United States of America. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the Company'sinternal control over financial reporting as of December 31, 2018, based on criteria established in Internal Control – Integrated Framework (2013) issued bythe Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) and our report dated March 18, 2019 expressed an unqualified opinionthereon. Basis for Opinion These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’sconsolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and theapplicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonableassurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. Our audits included performingprocedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures thatrespond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating theoverall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion. /s/ BDO USA, LLPWe have served as the Company's auditor since 2011. Melville, NYMarch 18, 2019F-1 Table of ContentsCHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIESCONSOLIDATED BALANCE SHEETSAS OF- ASSETS - December 31, 2018 December 31, 2017 CURRENT ASSETS: Cash and cash equivalents $12,524,551 $3,790,302 Accounts receivable, net of allowance for doubtful accounts of $42,000 at December 31, 2018 and 2017,respectively 7,373,971 2,085,340 Inventories, net 7,851,222 4,423,618 Prepaid expenses and other current assets 702,010 554,383 TOTAL CURRENT ASSETS 28,451,754 10,853,643 FIXED ASSETS, net of accumulated depreciation 2,873,920 1,909,232 OTHER ASSETS: Intangible assets, net 3,884,831 1,597,377 Goodwill 4,983,127 1,666,610 Deposits and other assets 717,551 589,159 TOTAL ASSETS $40,911,183 $16,616,021 - LIABILITIES AND STOCKHOLDERS’ EQUITY - CURRENT LIABILITIES: Accounts payable and accrued liabilities $5,888,681 $3,046,303 Deferred revenue 422,905 50,000 Current portion of note payable 207,694 - TOTAL CURRENT LIABILITIES 6,519,280 3,096,303 OTHER LIABILITIES: Note payable 171,821 99,480 Deferred tax liability 892,308 341,042 TOTAL LIABILITIES 7,583,409 3,536,825 COMMITMENTS AND CONTINGENCIES (Note 13) STOCKHOLDERS’ EQUITY: Preferred stock – 10,000,000 shares authorized, none outstanding - - Common stock - $.01 par value; 100,000,000 shares authorized, 17,166,459 and 12,318,570 shares issued andoutstanding at December 31, 2018 and 2017, respectively 171,664 123,185 Additional paid-in capital 90,953,788 62,821,288 Accumulated deficit (57,909,874) (50,044,225)Accumulated other comprehensive income 112,196 178,948 TOTAL STOCKHOLDERS’ EQUITY 33,327,774 13,079,196 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $40,911,183 $16,616,021 See accompanying notes to consolidated financial statementsF-2 Table of ContentsCHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS For the years ended December 31, 2018 December 31, 2017 REVENUES: Net product sales $26,741,020 $19,322,302 License and royalty revenue 948,773 741,534 R&D and grant revenue 5,719,458 3,951,591 TOTAL REVENUES 33,409,251 24,015,427 COSTS AND EXPENSES: Cost of product sales 21,427,243 12,921,157 Research and development expenses 8,526,256 8,555,381 Selling, general and administrative expenses 11,100,775 8,963,363 Acquisition costs 337,645 58,076 41,391,919 30,497,977 LOSS FROM OPERATIONS (7,982,668) (6,482,550) OTHER INCOME (EXPENSE): Interest income, net 49,498 22,485 LOSS BEFORE INCOME TAXES (BENEFIT) PROVISION (7,933,170) (6,460,065) Income tax (benefit) provision (67,521) (88,305) NET LOSS $(7,865,649) $(6,371,760) Basic loss per share $$ (0.55) $(0.52) Diluted loss per share $$ (0.55) $(0.52) Weighted average number of shares outstanding, basic 14,432,505 12,300,031 Weighted average number of shares outstanding, diluted 14,432,505 12,300,031 See accompanying notes to consolidated financial statementsF-3 Table of ContentsCHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS For the years ended December 31, 2018 December 31, 2017 Net loss $(7,865,649) $(6,371,760)Other comprehensive income: Foreign currency translation adjustments (66,752) 178,948 COMPREHENSIVE LOSS $(7,932,401) $(6,192,812)See accompanying notes to consolidated financial statementsF-4 Table of ContentsCHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018, AND 2017 Common Stock AdditionalPaid-in-Capital AccumulatedDeficit AOCI Total Shares Amount Amount Amount Amount Amount Balance at December 31, 2016 12,026,847 $120,268 $60,721,783 $(43,672,465) $- $17,169,586 Common Stock: Purchase of RVR Diagnostics Sdn Bhd 269,236 2,692 1,680,033 - - 1,682,725 Options: Exercised 22,487 225 34,575 - - 34,800 Stock option compensation - - 384,897 - - 384,897 Comprehensive income - - - - 178,948 178,948 Net loss - - - (6,371,760) - (6,371,760) Balance at December 31, 2017 12,318,570 $123,185 $62,821,288 $(50,044,225) $178,948 $13,079,196 Common Stock: New stock from offerings 4,509,760 45,098 27,431,162 - - 27,476,260 Restricted stock issued 266,839 2,668 (2,668) - - - Restricted stock compensation - - 281,249 - - 281,249 Options: Exercised 71,290 713 71,201 - - 71,914 Stock option compensation - - 351,556 - - 351,556 Comprehensive loss - - - - (66,752) (66,752) Net loss - - - (7,865,649) - (7,865,649) Balance at December 31, 2018 17,166,459 $171,664 $90,953,788 $(57,909,874) $112,196 $33,327,774 See accompanying notes to consolidated financial statementsF-5 Table of ContentsCHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF CASH FLOWSFOR THE YEARS ENDED December 31, 2018 December 31, 2017 CASH FLOWS FROM OPERATING ACTIVITIES: Cash received from customers and grants $28,632,084 $24,971,299 Cash paid to suppliers and employees (40,452,110) (30,028,299)Income taxes paid (10,913) - Interest received, net 69,930 22,485 Interest paid (20,432) - Net cash used in operating activities (11,781,441) (5,034,515) CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of opTricon GmbH, net of cash acquired (5,491,204) - Purchase of RVR Diagnostics Sdn Bhd, net of cash acquired - (850,000)Acquisition of and deposits on fixed assets (1,467,192) (1,026,954)Net cash used in investing activities (6,958,396) (1,876,954) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from option exercises 71,914 34,800 Proceeds from note payable - 99,480 Payments on note payable (64,481) - Proceeds from sale of common stock, net 27,476,260 - Net cash provided by financing activities 27,483,693 134,280 Effect of exchange rate changes on cash (9,607) 13,027 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 8,734,249 (6,764,162) Cash and cash equivalents - beginning of the period 3,790,302 10,554,464 Cash and cash equivalents - end of the period $12,524,551 $3,790,302 RECONCILIATION OF NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES: Net Loss $(7,865,649) $(6,371,760)Adjustments: Depreciation and amortization 902,505 1,276,963 Fair value adjustment to contingent consideration - (148,000) Share based compensation 632,805 384,897 Change in deferred tax asset (78,432) - Changes in assets and liabilities, net of effects from purchase of opTricon GmbH: Accounts receivable (5,150,072) 1,298,389Inventories (3,077,104) (1,088,430) Prepaid expenses and other current assets (118,293) 285,762Deposits and other assets - (512,272) Accounts payable and accrued liabilities 2,599,894 182,453 Deferred revenue 372,905 (342,517) Net cash used in operating activities $(11,781,441) $(5,034,515) Supplemental disclosures for non-cash investing and financing activities: Deposits on manufacturing equipment transferred to fixed assets $257,455 $174,399 Deposits and other assets transferred to intangible assets 118,899 - Seller-financed equipment purchases 326,110 - Accrual of contingent earn-out - 148,000 Issuance of common stock for net assets of business acquired - 1,682,725 See accompanying notes to consolidated financial statementsF-6 Table of ContentsNOTE 1 — DESCRIPTION OF BUSINESS: Chembio Diagnostics, Inc. and its subsidiaries (collectively, the “Company” or “Chembio”), develop, manufacture, and commercialize point-of-carediagnostic tests that are used to detect and diagnose diseases. The Company is pursuing three corporate priorities: (1) expand its commercialization, (2)advance its research and development pipeline, and (3) prepare for future growth.All products that are currently being developed are based on the Company’s patented DPP® technology, a novel point-of-care diagnostic platform that offerscertain customer advantages as compared to traditional lateral flow technology.The Company’s product commercialization and product development efforts are focused on infectious disease testing and technology collaborations. Ininfectious disease, the Company is commercializing tests for HIV and Syphilis, Zika virus, and developing tests for malaria, dengue virus, chikungunya virus,ebola, lassa, Marburg, leptospirosis, Rickettsia typhi, Burkholderia pseudomallei, and Orientia tsutsugamushi, individually or as part of fever panel tests.Through technology collaborations, the Company is developing tests for a specific form of cancer, concussion, bovine tuberculosis, and for eosinophilicrespiratory disease, the latter in collaboration with global biopharmaceutical company AstraZeneca.Large and growing markets have been established for these kinds of tests, initially in high prevalence regions where they are indispensable for large scaleprevention and treatment programs. More generally, the Company believes there is and will continue to be a growing demand for diagnostic products thatcan provide accurate, actionable diagnostic information in a rapid, cost-effective manner at the point of care.The Company’s products are sold to medical laboratories and hospitals, governmental and public health entities, non-governmental organizations, medicalprofessionals and retail establishments, both domestically and internationally, under the Company’s STAT PAK®, SURE CHECK®, STAT-VIEW® or DPP®registered trademarks, or under the private labels of the Company’s marketing partners.The Company routinely enters into arrangements with governmental and non-governmental organizations for the funding of certain research anddevelopment efforts.NOTE 2 — ACQUISITIONS:opTriconOn November 6, 2018, pursuant to a share purchase agreement, the Company acquired all of the outstanding shares of opTricon GmbH (“opTricon”), aprivately-held Germany based developer and manufacturer of handheld analyzers for rapid diagnostic tests, for $5.5 million in cash, subject to routine post-closing adjustments. Since 2015, the Company and opTricon have been parties to an agreement under which the Company has collaborated in developing itsDPP Micro Reader, a handheld, battery-operated analyzer that uses an innovative image sensor to provide, when combined with the Company’s DPP tests, aquantitative interpretation of diagnostic results. The Company purchased opTricon because it believes it will enable it to promote DPP tests and DPP MicroReader more actively across global markets. The results of opTricon operations have been reflected in the consolidated financial statements since November6, 2018.As a result of the consideration paid exceeding the preliminary fair value of the net assets acquired, goodwill in the amount of $3,337,000 was recorded inconnection with this acquisition, none of which will be deductible for tax purposes. In addition, the Company recorded $2,260,000 in intangible assetsassociated with the addition of opTricon’s developed technology and customer base. The Consolidated Statements of Operations for the year endedDecember 31, 2018 include $337,645 of transaction costs related to the opTricon acquisition.The acquisition was accounted for using the purchase method of accounting. The following table summarizes the preliminary allocation of the purchase priceto the estimated fair values of the assets acquired and liabilities assumed on the closing date of November 6, 2018: Amount Net current assets $ 404,204 Property, plant and equipment 125,000 Goodwill 3,337,000 Deferred tax liability (635,000)Other intangible assets (estimated useful life): Developed technology (7 years) 1,900,000 Customer contracts / relationships (10 years) 360,000 Total consideration $5,491,204 The Company calculated the fair value of the fixed assets based on the net book value of opTricon as that approximates fair value. The developedtechnology and customer contracts/relationships were based on discounted cash flows using management estimates.As indicated, the allocation of the purchase price shown above is preliminary, pending completion of an analysis of the deferred tax liability. Therefore, anadjustment may be required.The following represents unaudited pro forma operating results for the year ended December 31, 2018 as if the operations of opTricon had been included inthe Company’s Consolidated Statements of Operations as of January 1, 2018: Proforma December 31, 2018 Total revenues $35,442,806 Net loss (8,394,074) Net loss per common share $ (0.58) Diluted net loss per common share $(0.58)The pro forma financial information includes business combination accounting effects from the acquisition including amortization charges from acquiredintangible assets of opTricon approximately $351,000 for the year ended December 31, 2018. The unaudited pro forma information as presented above is forinformational purposes only and is not indicative of the results of operations that would have been achieved if the acquisition had taken place at thebeginning of fiscal 2018. Included in the proforma table above are opTricon's net revenues and pre-tax loss for the year ended December 31, 2018 which wereapproximately $2,214,000 and $213,000, respectively. opTricon's results of operations from the date of acquisition through December 31, 2018 areimmaterial to the Company's Consolidated Statements of Operations.RVR DiagnosticsOn January 9, 2017, pursuant to a stock purchase agreement (the "Stock Purchase Agreement), the Company acquired all of the outstanding common stock ofRVR Diagnostics Sdn Bhd ("RVR"), a privately-held Malaysia based manufacturing company focused on assembly and sales of rapid medical assays, for$3,231,000. The Company acquired RVR, which subsequently changed its name to Chembio Diagnostics Malaysia Sdn Bhd ("CDM"), to have a betterpresence in Asia, access to lower cost, shorter approval time of in-country regulatory approvals, and a lower cost assembly operation.Total consideration was: (i) a cash payment of $1,400,000, of which $550,000 was paid as a deposit in December 2016; (ii) 269,236 shares of Chembio'scommon stock, with a value at closing of $1,683,000, of which 7,277 shares were held back to satisfy certain potential claims under the Stock PurchaseAgreement and became issuable to the sellers on the one-year anniversary of the closing; and, a contingent $148,000 milestone payment based on theachievement of performance goals related to sales by CDM during the 12 months ended December 31, 2017. The performance goals were not achieved andthe related $148,000 accrual was reversed during the fourth quarter of 2017 and recognized in Selling, general, and administrative expenses associated withthe change in fair value.As a result of the consideration paid exceeding the preliminary fair value of the net assets acquired, goodwill in the amount of $1,503,361 was recorded inconnection with this acquisition, none of which will be deductible for tax purposes. In addition, the Company recorded $1,800,000 in intangible assetsassociated with the addition of CDM’s intellectual property, customer base and distribution channels, trade names, order backlog, industry reputation, andmanagement talent and workforce. The Condensed Consolidated Statements of Operations for the year ended December 31, 2017 include $25,000 oftransaction costs related to the CDM acquisition, which are reflected as Selling, general and administrative expenses.The acquisition was accounted for using the purchase method of accounting. The following table summarizes the allocation of the purchase price to theestimated fair values of the assets acquired and liabilities assumed on the closing date of January 9, 2017: Amount Property, plant and equipment $235,141 Goodwill 1,651,361 Deferred tax liability (307,636)Contingent consideration (148,000)Other intangible assets (estimated useful life): Intellectual property (10 years) 800,000 Customer contracts / relationships (10 years) 700,000 Order backlog (3 months) 200,134 Trade name (11 years) 100,000 Total consideration $3,231,000 The Company calculated the fair value of the fixed assets based on the net book value of CDM as that approximates fair value. The intellectual property,customer contracts and trade names were based on discounted cash flows using management estimates. The order backlog was based on an order that CDMhad at the closing that was shipped in the first quarter of 2017, and valued at an estimated net income.CDM's net revenues and pre-tax loss for the year ended December 31, 2017 were approximately $1,465,000 and ($406,000), respectively.F-7 Table of ContentsNOTE 3 — SIGNIFICANT ACCOUNTING POLICIES: (a)Principles of Consolidation:The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany transactionsand balances are eliminated in consolidation. Certain amounts from prior years have been reclassified to conform to the 2018 presentation.(b)Use of Estimates:The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States requiresmanagement to make assumptions and estimates that affect the amounts reported in the consolidated financial statements and accompanying notes.Judgments and estimates of uncertainties are required in applying the Company’s accounting policies in certain areas. Generally, matters subject toestimation and judgment include accounts receivable realization, inventory obsolescence, asset impairments, recognition of revenue persuant to milestones,useful lives of intangible and fixed assets, stock-based compensation, and deferred tax asset valuation allowances. Due to the inherent uncertainty involvedin making estimates, actual results reported in future periods may be based upon amounts that differ from those estimates.(c)Fair Value of Financial Instruments:The carrying value for cash and cash equivalents, accounts receivable, and accounts payable, approximate fair value due to the immediate or short-termmaturity of these financial instruments. Included in cash and cash equivalents is $4.7 million and $2.1 million as of December 31, 2018 and 2017,respectively, of money market funds that are Level 1 fair value measurements under the hierarchy. The fair value of the Company's notes payableapproximates the recorded value as the rate is based upon the current rates offered to the Company for similar financial instruments.Fair value measurements of all financial assets and liabilities that are being measured and reported on a fair value basis are required to be classified anddisclosed in one of the following three categories:Level 1:Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;Level 2:Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; andLevel 3:Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).(d)Cash and Cash Equivalents:Cash and cash equivalents are defined as short-term, highly liquid investments with original maturities of three months or less.(e)Concentrations of Credit Risk:Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments and tradereceivables. The Company places its temporary cash instruments with well-known financial institutions and, at times, may maintain balances in excess of theFDIC insurance limit. The Company monitors the credit ratings of the financial institutions to mitigate this risk. Concentration of credit risk with respect totrade receivables is principally mitigated by the Company’s ability to obtain letters of credit from certain foreign customers and its diverse customer base,both in number of customers and geographic locations.(f)Inventories:Inventories, consisting of material, labor and manufacturing overhead, are stated at the lower of cost and net realizable value. Cost is determined on the first-in, first-out method. The Company’s policy is to periodically evaluate the market value of the inventory and the stage of product life cycle, and record awrite-down for any inventory considered slow moving or obsolete.(g)Fixed Assets:Fixed assets are stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of therespective assets, which range from three to seven years. Leasehold improvements are amortized over the useful life of the asset or the lease term, whichever isshorter. Deposits paid for fixed assets are capitalized and not depreciated until the related asset is placed in service.(h)License Agreements:The Company records up-front payments related to sublicense agreements as prepaids and amortizes them over their respective economic life. As of December 31, 2018 and 2017, total prepaids were $100,000 and $100,000, respectively.Amortization expenses for the licenses above for the years ended December 31, 2018, and 2017 were $0, and $137,500, respectively.(i)Valuation of Long-Lived Assets and Intangible Assets:Long-lived assets to be held and used are analyzed for impairment whenever events or changes in circumstances indicate that the related carrying amountsmay not be recoverable. The Company evaluates at each balance sheet date whether events and circumstances have occurred that indicate possibleimpairment. If there are indications of impairment, the Company uses future undiscounted cash flows of the related asset or asset grouping over the remaininglife in measuring whether the assets are recoverable. In the event such cash flows are not expected to be sufficient to recover the recorded asset values, theassets are written down to their estimated fair value. No impairment of long-lived tangible and intangible assets was recorded for the years ended December31, 2018 and 2017.F-8 Table of Contents(j)Revenue Recognition:In May 2014, the Financial Accounting Standards Board (“FASB”) issued converged guidance on recognizing revenue in contracts with customers,Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers. The intent of the new standard is to improve financial reportingand comparability of revenue globally. The core principle of the standard is for a company to recognize revenue in a manner that depicts the transfer of goodsor services to customers in an amount that reflects the consideration which the company expects to receive in exchange for those goods or services. Theguidance provides a five-step analysis of transactions to determine when and how revenue is recognized. Other major provisions include capitalization ofcertain contract costs, consideration of the time value of money in the transaction price, and in certain circumstances, allowing estimates of variableconsideration to be recognized before contingencies are resolved. The guidance also requires enhanced disclosures regarding the nature, amount, timing anduncertainty of revenue and cash flows arising from an entity’s contracts with customers.The new revenue standards became effective for the Company on January 1, 2018 and were adopted using the modified retrospective method. The adoptionof the new revenue standards as of January 1, 2018 did not change the Company’s revenue recognition as its revenues continue to be recognized when thecustomer takes control of its product. As the Company did not identify any material accounting changes that impacted the amount of reported revenues withrespect to its product revenue, license and royalty revenue, and R&D, milestone and grant revenues, no adjustment to retained earnings was required uponadoption.The Company adopted the standards to contracts that were not completed at the date of initial application (January 1, 2018).Under the new revenue standards, the Company recognizes revenues when its customer obtains control of promised goods or services, in an amount thatreflects the consideration which the Company expects to receive in exchange for those goods or services. The Company recognizes revenues following thefive-step model prescribed under ASU No. 2014-09: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii)determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) theCompany satisfies the performance obligation.Product RevenuesRevenues from product sales are recognized and commissions are accrued when the customer obtains control of the Company’s product, which occurs at apoint in time, typically upon tendering to the customer. The Company expenses incremental costs of obtaining a contract as and when incurred because theexpected amortization period of the asset that it would have recognized is one year or less or the amount is immaterial. Freight and distribution activities onproducts are performed after the customer obtains control of the goods. The Company has made an accounting policy election to account for shipping andhandling activities that occur either when or after goods are tendered to the customer as a fulfillment activity, and therefore recognizes freight anddistribution expenses in Cost of Product Sales.The Company’s payment terms vary by the type and location of the Company’s customer and products or services offered. Payment terms differ byjurisdiction and customer but payment is generally required in a term ranging from 30 to 60 days from date of shipment or satisfaction of the performanceobligation.Reserves for Discounts and AllowancesRevenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with theCompany’s customers. The Company’s process for estimating reserves established for these variable consideration components does not differ materiallyfrom its historical practices.Product revenue reserves, which are classified as a reduction in product revenues, are generally related to discounts. Estimates of variable consideration andthe determination of whether to include estimated amounts in the transaction price are based on all information (historical, current and forecasted) that isreasonably available to the Company, taking into consideration the type of customer, the type of transaction and the specific facts and circumstances of eacharrangement. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint andis included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will notoccur in a future period. Actual amounts may ultimately differ from the Company’s estimates. If actual results vary, the Company adjusts these estimates,which could have an effect on earnings in the period of adjustment.Royalty RevenuesThe Company receives royalty revenues on sales by its licensees of products covered under patents that it owns. The Company does not have futureperformance obligations under these license arrangements. The Company records these revenues based on estimates of the sales that occurred during therelevant period as a component of license and royalty revenues. The relevant period estimates of sales are based on interim data provided by licensees andanalysis of historical royalties that have been paid to the Company, adjusted for any changes in facts and circumstances, as appropriate. Differences betweenactual and estimated royalty revenues are adjusted for in the period in which they become known, typically the following quarter. Historically, adjustmentshave not been material when compared to actual amounts paid by licensees.R&D and grant revenueAll such contracts are evaluated under the five-step model described above. For certain contracts that represent grants where the funder does not meet thedefinition of a customer, the Company recognizes revenue when earned in accordance with ASC 958. Such contracts are further described underDisaggregation of Revenue, below. Grants are invoiced and revenue is recognized as expenses are incurred as that is the depiction of the timing of thetransfer of services. Performance obligations generally follow the major phases of product development processes: design feasibility & planning, productdevelopment & design optimization, design verification, design validation & process validation, and pivotal studies.Disaggregation of RevenueThe following tables disaggregate Total Revenues for the year ended December 31, 2018: ExchangeTransactions Non-ExchangeTransactions Total Net product sales $26,741,020 $- $26,741,020 License and royalty revenue 948,773 - 948,773 R&D, milestone and grant revenue 2,687,210 3,032,248 5,719,458 $30,377,003 $3,032,248 $33,409,251 Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASC 985.F-9 Table of Contents Total Africa $8,605,306 Asia 1,389,120 Europe & Middle East 4,726,691 Latin America 11,722,224 United States 6,965,910 $33,409,251 Contract LiabilitiesDeferred revenue relates to payments received in advance of performance under the contract. Deferred revenue is recognized as revenue as (or when) theCompany performs under the contract. At December 31, 2017, the Company reported $50,000 in deferred revenue of which $50,000 was earned andrecognized as R&D, milestone and grant revenue during the year ended December 31, 2018. At December 31, 2018, the Company reported $422,905 indeferred revenue which is expected to be recognized during the first quarter of 2019.In April 2017, the Company entered into a $1.0 million agreement with FIND to develop a simple, point-of-care fever panel assay that can identify multiplelife-threatening acute febrile illnesses common in the Asia Pacific region. The Company earned $0.1 million and $0.9 million for the year ended December31, 2018, and from inception through December 31, 2018, respectively as R&D, milestone and grant revenue in the Company’s Consolidated Statements ofOperations.In August 2016, the Company was awarded a grant of $5.9 million from BARDA, which is part of the U.S. Department of Health And Human Resources todevelop a rapid Zika virus assay. The Company earned $2.6 million and $5.3 million for the year ended December 31, 2018 and from inception throughDecember 31, 2018, respectively, as R&D, milestone and grant revenue in the Company’s Consolidated Statements of Operations.In September 2016, the Company was awarded a $0.7 million contract from the USDA to develop a Bovid TB assay. The Company earned $0.2 million and$0.5 million for the year ended December 31, 2018 and from inception through December 31, 2018, respectively, as R&D, milestone and grant revenue in theCompany’s Consolidated Statements of Operations.(k)Research and Development:Research and development (R&D) costs are expensed as incurred. Advance payments for goods and services that will be used in future research anddevelopment activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.(l)Stock-Based Compensation:The fair value of restricted stock and restricted stock unit awards are their fair value on the date of grant. Stock-based compensation expense for stock optionsis calculated using the Black-Scholes valuation model based on awards ultimately expected to vest together with the fair value of restricted stock andrestricted stock unit awards, are, reduced for actual forfeitures, and, expensed on a straight-line basis over the requisite service period of the grant. During2017, the Company adopted ASU 2016-09, "Improvements to Employee Share-Based Payment Accounting". (m)Income Taxes:The Company accounts for income taxes under an asset and liability approach that recognizes deferred tax assets and liabilities based on the differencebetween the financial statement carrying amounts and the tax bases of assets and liabilities using enacted tax rates in effect in the years in which thedifferences are expected to reverse.The Company follows a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken, or expected to be taken,in a tax return. The guidance relates to, among other things, classification, accounting for interest and penalties associated with tax positions, and disclosurerequirements. Any interest and penalties accrued related to uncertain tax positions are recorded in tax expense.The Company assesses the realizability of its net deferred tax assets on an annual basis. If, after considering all relevant positive and negative evidence, it ismore likely than not that some portion or all of the net deferred tax assets will not be realized, the Company will reduce the net deferred tax assets by avaluation allowance. The realization of net deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior tothe expiration of net operating loss carryforwards.(n)Loss Per Share:Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstandingfor the period including outstanding restricted stock that by its terms is includible in the calculation. Diluted loss per share for the years ended December 31,2018, and 2017 reflects the potential dilution from the exercise or conversion of other securities into common stock, if dilutive.There were 711,968, and 810,670 options outstanding as of December 31, 2018 and 2017, respectively, which were not included in the calculation of dilutedincome per share for the years ended because their effect would have been anti-dilutive. (o)Goodwill and Intangible Assets:Goodwill represents the excess of the purchase price the Company paid over the fair value of the net tangible and identifiable intangible assets acquired inthe Company’s acquisition of opTricon in November 2018 and CDM in January 2017. Goodwill is not amortized but rather is tested annually as of the firstday of the fiscal fourth quarter, or sooner if the Company believes that indicators of impairment exist. The Company makes a qualitative evaluation about thelikelihood of goodwill impairment, which is based on a number of applicable factors. If the Company concludes that it is more likely than not that thecarrying value of the applicable reporting unit is greater than its fair value, then it would recognize an impairment charge for the amount by which thecarrying value exceeds the reporting unit’s fair value, provided the impairment charge does not exceed the total amount of goodwill allocated to thereporting unit. For the year ended December 31, 2018 and 2017, there was no impairment of goodwill and other intangible assets.F-10 Table of Contents Following is a table that reflects changes in Goodwill: Beginning balance 1/1/18 $1,666,610 Acquisition of opTricon 3,337,000 Changes in foreign currency exchange rate (20,483) Balance at December 31, 2018 $4,983,127 Intangible assets consist of the following at: WeightedAverageRemaining Life December 31, 2018 December 31, 2017 Cost Accumulated Amortization Net Book Value Cost Accumulated Amortization Net Book Value Intellectual property 10 $1,089,688 $173,633 $916,055 $886,872 $88,687 $798,185 Developed technology 7 1,910,315 - 1,910,315 - - - Customercontracts/relationships 8 1,121,600 151,929 969,671 776,013 77,601 698,412 Order backlog - 217,187 217,187 - 221,867 221,867 - Trade names 9 108,521 19,731 88,790 110,859 10,079 100,780 $4,447,311 $562,480 $3,884,831 $1,995,611 $398,234 $1,597,377 Amortization expense for the year ended December 31, 2018 and 2017 was $233,734 and $398,234, respectively, and is recorded within Selling, General andAdministrative expenses. Amortization expense, subject to changes in currency exchange rates, is expected to be $496,512 per year from 2019 through 2023,and total $1,402,271 for all of the years thereafter.(p)Allowance for Doubtful Accounts: The Company records allowances for doubtful accounts for the estimated probable losses on uncollectible accounts receivable. The allowance is based uponthe credit worthiness of the Company’s customers, the Company’s historical experience, the age of the receivable and current market and economicconditions. Receivables are written off against these allowances in the period they are determined to be uncollectible.(q)Acquisition Costs:Acquisition costs include period expenses, primarily professional services, related to acquisition activities.(r)Foreign Currency Translation:The functional currency of a foreign subsidiary is the local currency. Assets and liabilities of foreign subsidiaries that use a currency other than U.S. dollars astheir functional currency are translated to U.S. dollars at end of period currency exchange rates. The consolidated statements of operations of foreignsubsidiaries are translated to U.S. dollars at average period currency exchange rates. The effect of translation for foreign subsidiaries is generally reported inOther comprehensive income. Foreign transaction gains are immaterial. (s)Recent Accounting Pronouncements Affecting the Company:In May 2014, the Financial Accounting Standards Board (“FASB”) issued converged guidance on recognizing revenue in contracts with customers,Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers. The intent of the new standard is to improve financial reportingand comparability of revenue globally. The core principle of the standard is for a company to recognize revenue in a manner that depicts the transfer of goodsor services to customers in an amount that reflects the consideration which the company expects to receive in exchange for those goods or services. Theguidance provides a five-step analysis of transactions to determine when and how revenue is recognized. Other major provisions include capitalization ofcertain contract costs, consideration of the time value of money in the transaction price, and in certain circumstances, allowing estimates of variableconsideration to be recognized before contingencies are resolved. The guidance also requires enhanced disclosures regarding the nature, amount, timing anduncertainty of revenue and cash flows arising from an entity’s contracts with customers. The standard is effective for the first interim period within annualreporting periods beginning after December 15, 2017.The Company has completed its evaluation of the new standard and assessed the impact of adoption on its consolidated financial statements. The Companyreviewed significant open contracts with customers for each revenue stream, and based on its evaluation, revenue recognition under the new standard did nothave a material impact on the Company’s consolidated financial statements because: i) product sales revenue is recognized when control of the goods istransferred to the customer (i.e., the date of shipment, which is consistent under ASC 605), and ii) R&D and grant revenue historically did not constituteexchange transactions and therefore the new standard did not apply to such revenue upon adoption. The Company also assessed its control framework as aresult of adopting the new standard and noted minimal, insignificant changes to its systems and other controls processes.The new standard permitted two adoption methods under ASU 2014-09. The guidance could be adopted through either retrospective application to allperiods presented in the consolidated financial statements (full retrospective) or through a cumulative effect adjustment to retained earnings at the effectivedate (modified retrospective). The Company adopted the new standard effective January 1, 2018 using the modified retrospective transition method. Underthat method, the Company applied the rules to all contracts existing as of January 1, 2018. The cumulative effect was not material. In November 2015, the FASB issued ASU 2015-17, Income Taxes (Topic 740) Balance Sheet Classification of Deferred Assets. This ASU is intended tosimplify the presentation of deferred taxes on the balance sheet and will require an entity to present all deferred tax assets and deferred tax liabilities as non-current on the balance sheet. Under the current guidance, entities are required to separately present deferred taxes as current or non-current. Netting deferredtax assets and deferred tax liabilities by tax jurisdiction will still be required under the new guidance. This guidance became effective for Chembio beginningin 2018. This new accounting standard update did not have a material impact on the Company's consolidated financial statements.In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 requires the entity to recognize the assets and liabilities for therights and obligations created by leased assets. Leases will be classified as either finance or operating, with classification affecting expense recognition in theincome statement. In July 2018 the FASB issued ASU 2018-10, Codification Improvements to Topic 842, Leases, and ASU 2018-11, Leases (Topic 842)Targeted Improvements, which provide supplemental adoption guidance and clarification to ASU 2016-02, and must be adopted concurrently with theadoption of ASU 2016-02, cumulatively referred to as “Topic 842”. Topic 842 is effective for the company in the first quarter of 2019, with early adoptionpermitted, and is to be applied using either a modified retrospective approach, or an optional transition method which allows an entity to apply the newstandard at the adoption date with a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption.The Company will adopt Topic 842 on January 1, 2019 under the optional transition method and elect the short-term lease exception and available practicalexpedients. Under the transition method, the Company will not adjust its comparative period financial information or make the new required leasedisclosures for periods before the effective date. Upon adoption, the Company expects the consolidated balance sheet to include a right of use asset andliability related to substantially all of the Company’s lease arrangements. While the Company continues to evaluate the effects of adopting the provisions ofTopic 842, including the impact that this new guidance will have on its processes and controls, the Company expects most existing operating leasecommitments will be recognized as operating lease liabilities and right-of-use assets upon adoption. The adoption is not expected to be material to theconsolidated financial statements, and based on the Company’s ongoing assessment, is expected to increase total assets and total liabilities by no more thanapproximately $1.5 million, on a discounted basis.Please see Note 15 – Subsequent Events, regarding the Company’s entering into a commercial real estate lease for a new corporate headquarters and asublease for one of its current facilities on February 5, 2019. The Company is currently analyzing the impact of Topic 842 on these transactions and expectsto report on that during the first quarter of 2019. Based on the term and rental cost, the Company expects the application of Topic 842 to these transactions tohave a material impact on the Company’s total assets and total liabilities, and no impact on the Company’s results of operations or cash flows.F-11 Table of Contents In March 2016, the FASB issued authoritative guidance under ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to EmployeeShare-Based Payment Accounting. ASU 2016-09 provides for simplification of several aspects of the accounting for share-based payment transactions,including income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. The Companyadopted ASU 2016-09 on January 1, 2017. As the Company has a full valuation allowance against its U.S. net deferred tax assets, the adoption of thisstandard for recognition of the tax effect of deductions for employee share awards in excess of compensation costs (“windfall”) did not have a material impacton its consolidated financial statements and related disclosures. See Note 8 – Income Taxes, for additional information. Should the full valuation allowancebe reversed in future periods, the adoption of this new guidance could introduce more volatility in the calculation of the Company’s effective tax rate,depending on the Company’s share price at exercise or vesting of share-based awards as compared to grant date. The other provisions of ASU 2016-09 did nothave a material impact on the Company's consolidated financial statements and related disclosures.In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments, whichprovides guidance related to cash flows presentation. The Company adopted ASU 2016-15 in the first quarter of 2018. The guidance in ASU 2016-15 isgenerally consistent with the Company’s current cash flow classifications, and did not have a material impact on the Company’s consolidated financialstatements.In January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment, which requiresan entity to no longer perform a hypothetical purchase price allocation to measure goodwill impairment. Instead, impairment will be measured using thedifference between the carrying amount and the fair value of the reporting unit. This update will be effective for annual and interim periods in fiscal yearsbeginning after December 15, 2019. Early adoption is permitted. The Company adopted ASU 2017-04 in the fourth quarter of 2017. The adoption of thisstandard did not have a material impact on the Company’s consolidated financial statements and related disclosures.In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting, to provide clarity towhich changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. The Companyadopted ASU 2017-09 in the first quarter of 2018. Adoption did not have a material effect on the Company’s consolidated financial statements.In July 2018, the FASB issued ASU 2018-08 Not-for-Profit Entities (Topic 958): Clarifying the Scope and the Accounting Guidance for ContributionsReceived and Contributions Made to clarify the accounting guidance related to contributions made or received. This guidance primarily affects not-for-profitentities, although it also applies to businesses to the extent that they make or receive contributions, including grants. ASU 2018-08 clarifies and improves thescope and accounting guidance for both contributions received and made in order to assist entities in evaluating if those transactions should be accounted foras contributions under the scope of Topic 958, or as an exchange transaction subject to other guidance. Public entities are required to apply the amendmentson contributions received and contributions made to annual periods beginning after June 15, 2018, and December 15, 2018, respectively, each includinginterim periods within those annual periods. Early adoption is permitted, and the Company adopted ASU 2018-08 effective as of January 1, 2018. The impactof adoption was immaterial.NOTE 4 — INVENTORIES:Inventories consist of the following at: December 31, 2018 December 31, 2017 Raw Materials $2,803,677 $1,767,684 Work in Process 263,043 286,413 Finished Goods 4,784,502 2,369,521 $7,851,222 $4,423,618 NOTE 5 — FIXED ASSETS:Fixed assets consist of the following at: December 31, 2018 December 31, 2017 Machinery and Equipment $6,070,137 $4,582,759 Furniture and Fixtures 35,287 449,548 Computer Equipment 435,348 422,946 Leasehold Improvements 2,334,512 2,258,779 Enterprise Business Systems 462,420 - Less: Accumulated Depreciation and Amortization (6,463,784) (5,804,800) $2,873,920 $1,909,232 There were no capital leases at the end of December 31, 2018. Fixed assets at December 31, 2018 also include $1,866,126 in equipment that is undergoingvalidation and as such is not yet being depreciated. Depreciation expense for the 2018 and 2017 years totaled $634,261 and $727,563, respectively.As of December 31, 2018 and 2017, the Company had paid deposits on various pieces of equipment classified within Deposits and Other Assets aggregating$428,859 and $257,455, respectively.NOTE 6 — ACCOUNTS PAYABLE AND ACCRUED LIABILITIES:Accounts payable and accrued liabilities consist of the following at: December 31, 2018 December 31, 2017 Accounts Payable - suppliers $3,622,765 $1,494,759 Accrued Commissions 588,131 126,827 Accrued Royalties / license fees 279,213 429,297 Accrued Payroll 48,867 187,305 Accrued Vacation 264,789 309,767 Accrued Bonuses 494,318 282,500 Accrued Expenses - Other 590,598 215,848 $5,888,681 $3,046,303 F-12 Table of ContentsNOTE 7 — DEFERRED RESEARCH AND DEVELOPMENT REVENUE:The Company recognizes income from R&D milestones when those milestones are reached and non-milestone contracts and grants when earned. Theseprojects are invoiced after expenses are incurred. Any projects or grants funded in advance are deferred until earned. As of December 31, 2018 and 2017, therewere $422,905 and $50,000 unearned advanced revenues, respectively.NOTE 8 — INCOME TAXES:The (benefit from) provision for income taxes for the years ended December 31, 2018 and 2017 is comprised of the following: 2018 2017 Current Federal $- $(97,339)State 10,914 9,034 Foreign - - Total current (benefit) provision 10,914 (88,305) Deferred Federal - - State - - Foreign (78,435) - Total deferred (benefit) provision (78,435) - Total (benefit) provision $(67,521) $(88,305)On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the “Tax Act”) was signed into law making significant changes to the Internal Revenue Code.Changes include, but are not limited to, a corporate tax rate decrease from 34% to 21% effective for tax years beginning after December 31, 2017, thetransition of U.S international taxation from a worldwide tax system to a territorial system, and a one-time transition tax on the mandatory deemedrepatriation of cumulative foreign earnings as of December 31, 2017. The Staff of the Securities and Exchange Commission issued Staff Accounting BulletinNo. 118 ("SAB 118") to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared oranalyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Tax Act. As a result of the Tax Act,the Company remeasured its U.S. Federal deferred tax assets and liabilities at the rate they are expected to reverse in the future. The Company recorded acumulative charge of $3,906,774 ($0 in 2018 and $3,906,774 in 2017), which was fully offset by an equivalent adjustment to the deferred tax valuationallowance. The Company recorded a cumulative benefit of $97,339 ($0 in 2018 and $97,339 in 2017) related to a credit for alternative minimum taxes(AMT) paid in prior years. During 2018, the Company finalized its computation of the impact of the Tax Act with no change to the provisional amount.In January 2018, the FASB released guidance on the accounting for tax on the global intangible low-taxed income ("GILTI") provisions of the Tax Act. TheGILTI provisions impose a tax on foreign income in excess of a deemed return on tangible assets of foreign corporations. The guidance allows companies tomake an accounting policy election to either (1) account for GILTI as a component of tax expense in the period in which they are subject to the rules (theperiod cost method), or (ii) account for GILTI in the Company's measurement of deferred taxes (the deferred method). After completing the analysis of theGILTI provisions, the Company elected to account for GILTI using the period cost method. The Company had an ownership change as described in Internal Revenue Code Sec. 382 during 2004 (“2004 change”). As a result, the Company’s netoperating losses prior to the 2004 change of $5,832,516 were subject to an annual limitation of $150,608 and for the first five (5) years are entitled to a BIG(Built-In-Gains) of $488,207 per year. These net operating losses expire in 2019 through 2024.The Company had a second ownership change during 2006 (“2006 change”). The net operating losses incurred between the 2004 change and the 2006change of $8,586,861 were subject to an annual limitation of $1,111,831 and for the first five (5) years are entitled to a BIG of $1,756,842 per year. These netoperating losses expire in 2024 through 2026.After applying the above limitations, at December 31, 2018, the Company has post-change net operating loss carry-forwards of approximately $27,303,044which expire between 2019 and 2037 and $5,432,085 which do not expire. In addition the Company has research and development tax credit carryforwardsof approximately $1,696,870 for the year ended December 31, 2018, which expire between 2019 and 2036.F-13 Table of Contents The Company has state net operating loss carryforwards of approximately $1,784,554 which expire between 2025 and 2037. The Company has foreign netoperating loss carryforwards of approximately $586,206 which do not expire. 2018 2017 Inventory reserves $204,206 $244,158 Accrued expenses 175,168 102,332 Net operating loss carry-forwards 7,122,576 5,800,144 Research and development credit 1,696,870 1,918,137 Stock-based compensation 215,797 167,522 Depreciation 139,362 91,258 Total deferred tax assets 9,553,979 8,323,551 Intangibles (968,849) (341,042) Total deferred tax liabilities (968,849) (341,042) Net deferred tax assets before valuation allowance 8,585,130 7,982,509 Less valuation allowances (9,477,438) (8,323,551)Net noncurrent deferred tax liabilities $(892,308) $(341,042) The components of (loss) before income taxes consisted of the following: Year Ending December 31, 2018 2017 United States operations $(7,137,428) $(6,054,002)International operations (795,742) (406,063)(Loss) before taxes $(7,933,170) $(6,460,065)A reconciliation of the Federal statutory rate to the effective rate applicable to loss before income taxes is as follows: Year Ending December 31, 2018 2017 Federal income tax at statutory rates 21.00% 34.00%State income taxes, net of federal benefit (.10)% (0.09)%Nondeductible expenses (1.58)% (1.04)%Foreign rate differential .36% (2.14)%Change in valuation allowance (18.44)% (99.41)%Impact of Tax Act on valuation allowance -% 60.48%AMT refund under Tax Act -% 1.51%Tax credits -% 7.07%Other (.39)% 0.99%Income tax benefit .85% 1.37%Interest and penalties, if any, related to income tax liabilities are included in income tax expense. As of December 31, 2018, the Company does not have aliability for uncertain tax positions.The Company files Federal and state income tax returns, opTricon files in Germany and CDM files in Malaysia and has been on tax holiday which expired onDecember 31, 2018. With few exceptions, tax years for fiscal 2015 through 2018 are open and potentially subject to examination by federal, state and foreigntaxing authorities.NOTE 9 — STOCKHOLDERS’ EQUITY:(a)Common StockIn February 2018, the Company closed on an underwritten registered public offering of 1,783,760 shares of its common stock at $6.75 per share. The netproceeds of the offering, after deducting the underwriter’s discounts and other offering expenses payable by the Company, was approximately $10.9 million.In November 2018, the Company closed on an underwritten public offering of 2,726,000 shares of its common stock, including the underwriter’s exercise ofits overallotment of 355,565 shares, at $6.75 per share. The net proceeds of the offering, after deducting the underwriter’s discounts and other offeringexpenses payable by the Company, was approximately $16.5 million.During 2018, options to purchase 144,947 shares of the Company’s common stock were exercised for 71,290 shares of common stock at exercise pricesranging from $3.48 to $5.64 by surrendering options and shares of common stock already owned.During 2017, options to purchase 56,969 shares of the Company’s common stock were exercised for 22,487 shares of common stock at exercise pricesranging from $3.48 to $4.45 by surrendering options and shares of common stock already owned.F-14 Table of Contents(b)Preferred StockThe Company has 10,000,000 shares of preferred stock authorized and none outstanding. These shares can become issuable upon an approved resolution bythe board of directors and the filing of a Certificate of Designation with the state of Nevada.(c)Options, Restricted Stock, and Restricted Stock UnitsThe Board of Directors or its Compensation Committee may issue options, restricted stock, and restricted stock units pursuant to employee stock incentiveplans that have been approved by the Company's stockholders.(d)WarrantsAs of December 31, 2018 and 2017, the Company had no warrants outstanding to purchase shares of common stock.NOTE 10 — RIGHTS AGREEMENT:In March 2016, the Company entered into a Rights Agreement (the "Rights Agreement") with Action Stock Transfer Corp., as Rights Agent. The RightsAgreement expired on March 7, 2019. Pursuant to the Rights Agreement, the Company declared a dividend distribution of one preferred share purchase right(a "Right") for each outstanding share of common stock as of March 8, 2016.Rights Initially Not Exercisable. The Rights were not exercisable until a Distribution Date (as defined below). Until a Right was exercised, the holderthereof, as such, would have no rights as a shareholder of the Company, including, without limitation, the right to vote or to receive dividends.Separation and Distribution of Rights. The Rights were evidenced by the certificates for common stock, and were not to be evidenced by separate rightscertificates until the close of business on the tenth business day (the “Distribution Date”) following either (i) a public announcement that a person or groupacquired beneficial ownership of 20% or more of the outstanding shares of common stock or (ii) a tender or exchange offer by any person or group is firstpublished, sent or given within the meaning of Rule 14d-3(a) under the Securities Exchange Act of 1934, the consummation of which would result in theperson or group having beneficial ownership of 20% or more of the outstanding shares of common stock.NOTE 11 — STOCK INCENTIVE PLANS:Effective June 3, 2008, the Company’s stockholders voted to approve the 2008 Stock Incentive Plan (“SIP”), with 625,000 shares of common stock availableto be issued. At the Annual Stockholder Meeting on September 22, 2011 the Company’s stockholders voted to approve an increase to the shares of commonstock issuable under the SIP by 125,000 to 750,000. Under the terms of the SIP, which expired during 2018, the Board of Directors or its CompensationCommittee had the discretion to select the persons to whom awards were to be granted. Awards could be stock options, restricted stock and/or restricted stockunits ("Equity Award Units"). The awards became vested at such times and under such conditions as determined by the Board or its CompensationCommittee. Cumulatively through December 31, 2018, there were 508,889 options exercised, and at December 31, 2018, 99,132 options were outstandingand no Equity Award Units were available to be issued under the SIP.Effective June 19, 2014, the Company’s stockholders voted to approve the 2014 Stock Incentive Plan (“SIP14”), with 800,000 shares of common stockavailable to be issued. Under the terms of the SIP14, the Board or its Compensation Committee has the discretion to select the persons to whom awards are tobe granted. Awards can be in the form of Equity Award Units. The awards become vested at such times and under such conditions as determined by theBoard or its Compensation Committee. Cumulatively through December 31, 2018, there were 85,407 options exercised, and at December 31, 2018, 405,968options were outstanding and 21,061 Equity Award Units were still available to be issued under the SIP14. During 2018, 266,839 shares of restricted stockand 20,725 restricted stock units were awarded under SIP14.The Company's results for the years ended December 31, 2018 and 2017 include stock-based compensation expense totaling $632,805 and $384,897,respectively. Such amounts have been included in the Consolidated Statements of Operations within cost of goods sold ($25,615 and $47,000, respectively),research and development ($78,831 and $89,400, respectively) and selling, general and administrative expenses ($528,360 and $248,497, respectively).Stock option compensation expense in the years ended December 31, 2018 and 2017 represents the estimated fair value of options outstanding which isbeing amortized on a straight-line basis over the requisite vesting period of the entire award.The weighted average estimated fair value of stock options granted in the years ended December 31, 2018 and 2017 were $3.76 and $2.77 per share,respectively. The fair value of options at the date of grant was estimated using the Black-Scholes option pricing model. The expected volatility is based uponhistorical volatility of the Company’s stock and other contributing factors. The expected term is based on the Company’s historical experience with similartype options.The weighted-average assumptions made in calculating the fair values of options are as follows for the respective years ended: December 31, 2018 December 31, 2017 Expected term (in years) 4.96 5.48 Expected volatility 39.91% 43.31%Expected dividend yield n/a n/a Risk-free interest rate 2.70% 1.78%The Company granted 93,750 new options during the year ended December 31, 2018.F-15 Table of ContentsThe following table provides stock option activity for the years ended December 31, 2018 and 2017: Number ofShares WeightedAverageExercise Price perShare WeightedAverageRemainingContractualTerm Aggregate IntrinsicValue Outstanding at December 31, 2016 600,549 4.55 3.43 years $1,463,052 Granted 267,875 6.40 Exercised 56,969 4.19 100,018 Forfeited/expired/cancelled 785 5.56 Outstanding at December 31, 2017 810,670 5.18 3.69 years $2,477,853 Exercisable at December 31, 2017 371,295 4.44 2.62 years $1,409,440 Outstanding at December 31, 2017 810,670 $5.18 3.69 years $2,477,853 Granted 93,750 $9.80 352,220 Exercised 144,947 $4.83 523,327 Forfeited/expired/cancelled 47,505 $8.82 154,583 Outstanding at December 31, 2018 711,968 $5.62 3.33 years $687,364 Exercisable at December 31, 2018 396,799 $4.70 2.66 years $568,956 The following table summarizes information about stock options outstanding at December 31, 2018: Stock Options Outstanding Stock Options Exercisable Range ofExercisePrices SharesOutstanding AverageRemainingContract Life(Year) WeightedAverageExercisePrice AggregateIntrinsicValue SharesExercisable WeightedAverageExercisePrice AggregateIntrinsicValue 1 to 2.79999 - - $- $- - $- $- 2.8 to 4.59999 304,343 1.90 3.45 672,896 254,343 3.46 560,711 4.6 to 6.39999 152,875 3.43 5.85 14,468 58,020 5.80 8,245 6.4 to 8.19999 207,875 5.05 7.31 - 75,041 7.21 - 8.2 to 12 46,875 4.60 11.45 - 9,375 11.45 - Total 711,968 3.33 $5.62 $687,364 396,779 $4.70 $568,956 As of December 31, 2018, there was $710,376 of net unrecognized compensation cost related to stock options that are not vested, which is expected to berecognized over a weighted average period of approximately 2.45 years. The total fair value of shares vested during the year ended December 31, 2018, was$553,000.The following table summarizes information about restricted stock and restricted stock units outstanding as of December 31, 2018: Number ofShares & Units WeightedAverageGrant DateFair Value Outstanding at December 31, 2017 - $- Granted 287,564 9.65 Exercised - - Forfeited/expired/cancelled - - Outstanding at December 31, 2018 287,564 9.65 Exercisable at December 31, 2018 - $- As of December 31, 2018, there was $1,688,746 of net unrecognized compensation cost related to restricted stock and restricted stock units that are notvested, which is expected to be recognized over a weighted average period of approximately 2.5 years. Stock based compensation cost related to restrictedstock and restricted stock units recognized during the years ended December 31, 2018 and 2017 was $281,249 and $0, respectively.F-16 Table of ContentsNOTE 12 — GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY:The Company produces only one group of similar products known collectively as “rapid medical tests,” and it operates in a single business segment. Netproduct sales by geographic area are as follows: For the years ended December 31, 2018 December 31, 2017 Africa $8,605,306 $3,568,455 Asia 1,389,120 1,626,750 Europe & Middle East 2,172,031 1,763,274 Latin America 11,722,224 8,476,003 United States 2,852,339 3,887,820 $26,741,020 $19,322,302 Long-lived assets by geographic area are as follows: 2018 2017 Asia $ 466,185 $ 472,774 Europe & Middle East 123,752 - United States 2,283,983 1,436,458 $2,873,920 $1,909,232 NOTE 13 — COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS:Employment Contracts:The Company has multi-year contracts with two key employees. The contracts call for salaries presently aggregating $770,000 per year, and they expire inMarch 2019 and March 2020. The following table is a schedule of future minimum salary commitments:2019 $485,493 2020 85,000 Pension Plan: The Company has a 401(k) plan established for its employees whereby it matches 40% of the first 5% (or 2% of salary) that an employee contributes to theplan. Matching contribution expenses totaled $94,544 and $91,150 for the years ended December 31, 2018 and 2017, respectively. Obligations Under Operating Leases:The Company leases industrial space used for office, R&D and manufacturing facilities, currently with a monthly rent of $30,140. The current lease expireson April 30, 2019. The lease provides for annual increases of 2.5% percent each year starting May 1, 2016. In February of 2014, the Company entered into alease for office and warehouse space, effective March 1, 2014, a short distance from its current facility currently with a monthly rent of $16,709. The space isused primarily for warehousing and provides for additional office space. The lease expires on April 30, 2020. The lease provides for annual increases of3.0% percent each year starting March 1, 2016. The Company also leases office, warehouse, and manufacturing space in a single building in Kuala Lumpur,Malaysia persuant to two separate leases that each expire on April 30, 2020 and have an additional three year renewal option with combined monthly rent ofapproximately $5,400. The Company also leases space in Germany for offices, manufacturing, and center of excellence for optical technology. The lease willautomatically renew annually on May 31. The monthly cost is estimated at $13,445 with yearly increases of 2%. The following is a schedule of future minimum rental commitments for the years ending December 31,2019 $384,308 2020 88,576 2021 - $472,884 Rent expense was $653,155 and $586,730 for the years ended December 31, 2018 and 2017, respectively.Economic Dependency:Customers are considered major customers when net sales exceed 10% of the Company's total net sales for period or outstanding trade receivables exceed10% of accounts receivable. The Company had the following major customers for the respective periods: For the years ended Accounts Receivable December 31, 2018 December 31, 2017 December 31, 2018 December 31, 2017 Sales % of Sales Sales % of Sales Customer 1 $11,171,174 42% $8,065,217 42% $3,499,340 $- Customer 2 4,346,640 16% - -% 1,033,824 - The following table delineates purchases the Company had with vendors in excess of 10% of total purchases for the periods indicated: For the years ended Accounts Payable December 31, 2018 December 31, 2017 December 31, 2018 December 31, 2017  Purchases % of Purc. Purchases % of Purc. Vendor 1 $* * $* * $* $* Vendor 2 * * 746,868 12% * * Vendor 3 * * 849,966 14% 164,312 * Vendor 4 1,646,614 16% 884,698 14% * * In the tables above, an asterisk (*) indicates that purchases from the vendor did not exceed 10% for the period indicated.The Company purchases materials pursuant to intellectual property rights agreements that are important components in its products. Management believesthat other suppliers could provide similar materials on comparable terms. A change in suppliers, however, could cause a delay in manufacturing and apossible loss of sales, which could adversely affect operating results.Litigation:From time to time, the Company is involved in certain legal actions arising in the ordinary course of business. The outcomes of such actions, eitherindividually or in the aggregate, are not expected to have a material adverse effect on the Company’s future financial position or results of operations.F-17 Table of ContentsNOTE 14 — NOTE PAYABLE:In September 2017, the Company entered into an agreement with an equipment vendor to purchase automated assembly equipment for approximately$660,000. The terms call for prepayments of 30% down, 60% at time of factory acceptance testing and 10% after delivery. The vendor agreed to lend theCompany 15%, 40%, and 10% of each originally scheduled payment, respectively. The Company will pay interest at an annual rate of 12% until delivery. Beginning in September 2018, the Company began making monthly payments of principal and interest of approximately $20,150, at an annual rate of 12%over a twenty-four month period.NOTE 15 — SUBSEQUENT EVENTS:On February 5, 2019, the Company entered into a commercial real estate lease for a new corporate headquarters comprised of 70,000 square feet of office,research and development, and warehouse space in Hauppauge, New York. The lease has an initial term of eleven years that can be extended, at theCompany’s option, for two additional terms of five years each. Rent under the lease, which is payable in monthly installments, totals approximately$900,000 for the initial year and then increases by approximately three percent each succeeding year. Upon lease inception, the Company provided asecurity deposit and paid four months base rent that together totaled approximately $450,000. The base rent which will be deducted against the rent duefollowing a nine-month free rent period.On February 5, 2019, the Company also entered into an agreement of sublease with an affiliate of the Hauppauge, NY facility landlord to sublet theCompany’s warehouse space and supplemental administrative office facility in Holbrook, New York. The sublease has a term that will (a) commence on thelater of March 18, 2019 and the date the Company vacates the premises and (b) terminate on April 29, 2020, which is immediately prior to the termination ofthe Company’s lease for the facility. The sublessee will pay the Company 50% of the Company’s rent and additional rent payments, which will totalapproximately $100,000 per year during the term of the sublease.F-18Exhibit 10.3CHEMBIO DIAGNOSTICS, INC.Restated Annual Incentive Bonus PlanThis Restated Annual Incentive Bonus Plan (the “Plan”), which amends and restates the Chembio Diagnostics, Inc. Annual Incentive Bonus Plan aspreviously adopted by the Compensation Committee of the Board of Directors of the Company (the “Committee”), has been approved and adopted by theCommittee as of March 15, 2019. The Plan is intended to enhance stockholder value by aligning the performance of Chembio Diagnostics, Inc. (the“Company”) and the variable-based compensation of the Company’s “executive officers” (as defined in Rule 3b-7 under the Securities Exchange Act of1934) and any other employees of the Company or its subsidiaries identified from time to time (collectively with respect to a Plan Year as defined below, the“Participants”). The Plan is effective starting January 1, 2019, will be based on a calendar year from January 1 through December 31 (each a “Plan Year”),and will renew automatically on January 1 of each year until terminated. Unless context otherwise dictates, each reference to the Plan within a particular PlanYear includes the bonus structure adopted with resect to such Plan Year.1.Plan AdministrationThe Committee shall administer the Plan. The Committee shall have all authority and discretion necessary to administer the Plan and to control its operation,and may delegate responsibilities to Company officers as it deems appropriate. All determinations and decisions of the Committee as to any disputedquestion arising under the Plan, including questions of construction and interpretation, shall be final, binding and conclusive upon all parties.The Committee will, subject to the provisions of the Plan, establish such rules and regulations as it deems necessary or advisable for the proper administrationof the Plan, and will make determinations and will take such other action in connection with or in relation to accomplishing the objectives of the Plan as itdeems necessary or advisable.No member of the Committee shall be personally liable by reason of any contract or other instrument related to the Plan executed by such member or on heror his behalf in her or his capacity as a member of the Committee, nor for any mistake of judgment made in good faith, and the Company shall indemnify andhold harmless each employee, officer or director of the Company to whom any duty or power relating to the administration or interpretation of the Plan maybe allocated or delegated, against any cost or expense (including legal fees, disbursements and other related charges) or liability (including any sum paid insettlement of a claim with the approval of the Board of Directors) arising out of any act or omission to act in connection with the Plan unless arising out ofsuch person’s own fraud or bad faith. The foregoing right of indemnification shall not be exclusive of any other rights of indemnification to which suchpersons may be entitled under the Company’s Articles of Incorporation or Bylaws, as a matter of law, or otherwise, or any power that the Company may haveto indemnify them or hold them harmless.2.ELIGIBILITY AND PARTICIPATIONParticipants with bonus incentives are eligible to receive annual incentive bonuses according to the Plan. Notwithstanding any other provision of the Plan,only an individual identified as a “Participant” in the written bonus structure adopted and approved by the Committee with respect to a Plan Year shall beentitled to any right or other benefits under the Plan, or under such bonus structure, for such Plan Year. Participants are eligible to receive incentive bonusesbased on their individual performance, the performance of the Company, the performance of the department, division or other operating group (each an“Operating Group”) in which they work, or other performance metrics established by the Committee with respect to one or more Plan Years.Unless an employment agreement or other written contract of a Participant otherwise provides, to be eligible for a bonus for Plan Year, a Participant must beemployed by the Company (or one of its subsidiaries) as of December 31 of that Plan Year and must continue to be employed by the Company (or one of itssubsidiaries) as of the payment date of the bonus. A Participant hired after commencement of the Plan Year shall be eligible for a pro-rated bonus, based onthe Participant’s date of hire. A Participant who is promoted into a position with a higher bonus target will have a pro-rated bonus based on her or his time ineach position and on the applicable individual performance targets for such positions, but calculated based on the Participant’s annual base pay as ofDecember 31 of the Plan Year.A Participant who has taken an approved leave of absence pursuant to the Company’s policies during the Plan Year shall receive a pro-rated bonus calculatedby excluding the number of days that exceed an approved leave of absence. A Participant who is on an approved leave of absence on the date the bonuspayment is made will be eligible to receive the pro-rated bonus as calculated above upon the bonus payment date.3.Award DeterminationPerformanceCompany performance shall be determined by the Committee based on the Company’s ability to meet or exceed Company goals as set forth by theCommittee, which may include such factors as sales revenue, operating income (loss), earnings before income tax, depreciation and amortization(“EBITDA”), adjusted EBITDA (as defined by the Committee), product development, regulatory milestones, strategic alliances, licensing and partneringtransactions, and financings.Operating Group performance shall be determined by the Committee based on the Operating Group’s ability to meet or exceed Company goals as setforth by the Committee, which may include the factors identified with respect to Company performance, to the extent they pertain to the OperatingGroup, and any other factors identified by the Company, which may include factors reviewed with and recommended to the Committee by the ChiefExecutive Officer.Individual performance of the Participants, except for the Chief Executive Officer, shall be reviewed with and recommended to the Committee by theChief Executive Officer. The individual performance of each Participant, including the Chief Executive Officer, shall be determined by the Committee inits sole discretion, and in all cases shall be based on the individual Participant’s satisfactory completion of individual performance goals.AmountThe amount of a Participant’s bonus is based on an incentive percentage of such Participant’s annual base pay as of December 31 of the Plan Year. Theincentive percentage will equal:·for a Participant without a written contract, a percentage determined by the Committee at the beginning of the Plan Year; and·for a Participant with a written contract, the incentive percentage shall be as stated in that Participant’s written contract.The incentive percentage for a Participant may then be adjusted, in the sole discretion of the Committee, based on the performance of the Company, anOperating Group, or the individual Participant over the course of the Plan Year to arrive at a final performance percentage. The allocation of the finalperformance percentage shall be determined by the Committee at the beginning of the Plan Year and communicated to each employee in Section 5below.Unless a written contract of a Participant otherwise provides, only achievement of 100% of all Company, Operating Group and individual performancetargets for a Participant will accrue 100% of the Participant’s allocated percentage.4.Payment of AwardsA Participant’s bonus will be paid in cash and all determinations and decisions made by the Committee shall be final, conclusive and binding on allParticipants or other persons and shall be given the maximum deference permitted by law. Each Participant’s bonus payment shall be paid in one lump sumpayment, on or by a payment date to be determined by the Committee in its sole discretion. No bonus shall be paid to any Participant who is not an activeemployee of the Company on the last day of the Plan Year and on the payment date for such Plan Year.The Company shall withhold all applicable taxes from any bonus payment, including any federal, state and local taxes.5.Rights of ParticipantsThe Company intends that the potential bonus payments provided under the Plan be a term of employment and a part of each Participant’s compensation.Participation in the Plan shall not constitute an agreement of the Participant to remain in the employ of, and to render her or his services to the Company, orof the Company to continue to employ the Participant, and the Company may, subject to any applicable employment agreement, terminate the employmentof a Participant at any time with or without cause.No right or interest of any Participant in the Plan shall be assignable or transferable, or subject to any lien, directly, by operation of law or otherwise,including execution, levy, garnishment, attachment, pledge, and bankruptcy.6.Amendments and TerminationThe Committee may amend, modify, suspend, reinstate or terminate the Plan in whole or in part at any time or from time to time; provided, however, that nosuch action will adversely affect any right or obligation with respect to any Award theretofore made.7.MiscellaneousThe Plan supersedes all prior bonus plans or any written or verbal representations regarding the subject matter of the Plan. Participation in the Plan during aPlan Year will not convey any entitlement to participate in this or future plans or to any bonus payments of any nature under the Plan or otherwise. TheCommittee may at any time amend, suspend or terminate the Plan, including amendment of the target percentages for a Participant and amendment so as toensure that no amount paid or to be paid hereunder shall be subject to the provisions of Section 409(a)(1)(B) of the Internal Revenue Code of 1986. For theavoidance of doubt, it is intended that the Plan satisfy the exemption from the application of Section 409A of the Internal Revenue Code of 1986, and theTreasury Regulations and other guidance issued thereunder, and from the application of any state law of similar effect provided under Section 1.409A-1(b)(4)of the Treasury Regulations, and the Plan shall be administered and interpreted to the greatest extent possible in compliance therewith.The validity, construction, and effect of the Plan and any rules and regulations relating to the Plan and any bonus structure adopted with respect to a PlanYear shall be determined in accordance with the laws of the State of New York without giving effect to the conflict of law principles thereof.In the event any provision of the Plan shall be held illegal or invalid for any reason, the illegality or invalidity shall not affect the remaining parts of the Plan,and the Plan shall be construed and enforced as if the illegal or invalid provision had not been included.Exhibit 21.1CHEMBIO DIAGNOSTICS, INC.Subsidiaries of the RegistrantName of SubsidiaryJurisdiction of IncorporationChembio Diagnostic Systems Inc.DelawareChembio Diagnostics Malaysia Sdn. Bhd.MalaysiaopTricon GmbHGermanyBrillant 3006, GmbHGermanyExhibit 23.1Consent of Independent Registered Public Accounting FirmChembio Diagnostics, Inc.Medford, New YorkWe hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (No. 333-227398 and No. 333-215813) and Form S-8 (No.333-151785 and No. 333-203633) of Chembio Diagnostics, Inc. of our reports dated March 18, 2019, relating to the consolidated financial statements andthe effectiveness of Chembio Diagnostics, Inc.’s internal control over financial reporting, which appear in this Form 10-K./s/ BDO USA, LLPMelville, NYMarch 18, 2019Exhibit 31.1CERTIFICATIONI, John J. Sperzel, certify that:1. I have reviewed this Form 10-K of Chembio Diagnostics, Inc.;2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to makethe statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all materialrespects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (asdefined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a15(f) and 15d-15(f)) for the registrant and have:(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, toensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,particularly during the period in which this report is being prepared;(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposesin accordance with generally accepted accounting principles;(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recentfiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, theregistrant's internal control over financial reporting; and5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financialreporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonablylikely to adversely affect the registrant's ability to record, process, summarize and report financial information; and(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controlover financial reporting.Date: March 18, 2019/s/ John J. Sperzel John J. Sperzel, President & Chief Executive Officer Exhibit 31.2CERTIFICATIONI, Neil A. Goldman, certify that:1. I have reviewed this Form 10-K of Chembio Diagnostics, Inc.;2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a15(f) and 15d-15(f)) for theregistrant and have:(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensurethat material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularlyduring the period in which this report is being prepared;(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordancewith generally accepted accounting principles;(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectivenessof the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscalquarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, theregistrant’s internal control over financial reporting; and5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likelyto adversely affect the registrant’s ability to record, process, summarize and report financial information; and(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control overfinancial reporting.Date: March 18, 2019/s/ Neil A. Goldman Neil A. Goldman Executive Vice President & ChiefFinancial Officer Exhibit 32CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with the Annual Report on Form 10-K (the “Report”) of Chembio Diagnostics, Inc. (the “Company”) for the year ended December 31, 2018,each of the undersigned John J. Sperzel, the President & Chief Executive Officer of the Company, and Neil A. Goldman, the Executive Vice President & ChiefFinancial Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of2002, that, to the best of the undersigneds’ knowledge and belief:(1) This Form 10-K for the year ended December 31, 2018 fully complies with the requirements of Section 13(a) or 15(d) of the Securities ExchangeAct of 1934; and(2) The information contained in this Form 10-K for the year ended December 31, 2018 fairly presents, in all material respects, the financialcondition and results of operations of Chembio Diagnostics, Inc. for the periods presented therein.Dated: March 18, 2019/s/ John J. Sperzel John J. Sperzel President & Chief Executive Officer Dated: March 18, 2019/s/ Neil A. Goldman Neil A. Goldman Executive Vice President & ChiefFinancial Officer 

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