CODX Co Diagnostics Inc

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains “forward-looking statements.” Forward-looking statements reflect the current view about future events. When used in this Quarterly Report, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, identify forward-looking statements. Such statements, include, but are not limited to, statements contained in this Quarterly Report relating to our portfolio of products and tests, molecular diagnostics technologies, future opportunities, sales plans, product offerings, CE Mark designations and estimated costs, business strategy, additional investment capital, future revenue, expenses and operating results, and liquidity and capital resources. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated or anticipated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation:

Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned.

Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements. Each forward-looking statement speaks only as of the date on which it is made. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of future events or developments.

Critical Accounting Policies

The preparation of financial statements in conformity with U.S. GAAP requires that we make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our assumptions and estimates, including those related to recognition of revenue, valuation of investments, valuation of inventory, valuation of intangible assets, measurement of stock-based compensation expense and litigation. We base our estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

As an emerging growth company, we have elected to opt-in to the extended transition period for new or revised accounting standards. As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates.

Executive Overview

Co-Diagnostics, Inc. (“we,” “our,” the “Company” or “CDI”) is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. Our technology is utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). We also use our proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.

CDI’s diagnostics systems are designed to enable very rapid, low-cost, sophisticated molecular testing for organisms and genetic diseases by greatly automating historically complex procedures in both the development and administration of tests. CDI’s newest technical advance involves a novel approach to Polymerase Chain Reaction (“PCR”) primer design (cooperative primers) that eliminates one of the key vexing issues of PCR amplification, the exponential growth of primer-dimer pairs which adversely interferes with identification of the target DNA. In addition, CDI scientists have enhanced the understanding of the mathematics of DNA test design, so as to “engineer” a DNA test and automate algorithms to screen millions of possible designs to optimize DNA test design. CDI’s proprietary platform of Co-Dx™ technologies integrates and streamlines these steps as it analyzes biological samples.

Co-Diagnostics’ CoDx™ portfolio of molecular diagnostics development products and tests represents a new advancement in the understanding of the molecular interactions of DNA. The Company uses highly specialized, proprietary cooperative-theory mathematics that may lead to a revolutionary leap forward in the detection of infectious diseases, genetic disorders and other conditions. CoDx™ tests are a fraction of the cost of other DNA-based tests, designed for a new generation of affordable, mobile point-of-care diagnostic devices and compatible with many other devices, creating opportunities for state-of-the-art diagnostics available anywhere in the world, including developing countries.

Dr. Brent Satterfield, our Chief Technology Officer, created the Company’s suite of intellectual properties. Our technologies are now protected by five granted or pending U.S. patents, as well as certain trade secrets and copyrights. Our platform allows us to avoid paying existing patent royalties required by other PCR test systems, which has the potential of allowing CDI to sell diagnostic tests at a lower cost than competitors, while generating a profit margin.

Using its proprietary test design system and proprietary reagents, CDI will design and plans to sell PCR diagnostic tests for diseases and pathogens starting with tests for tuberculosis, a drug resistant tuberculosis test, hepatitis B and C, Malaria, dengue, HIV and Zika virus, all of which tests have been designed and verified in CDI’s laboratory.

Organizational History and Corporate Information

We were incorporated as Co-Diagnostics, Inc. in Utah on April 18, 2013. Our principal executive office is located at 2401 S. Foothill Drive, Suite D, Salt Lake City, Utah 84109. Our telephone number is (801) 438-1036. Our website address is http://codiagnostics.com

Product Offering

Caribbean and Central and South America

Our initial sales will be to entities within the Caribbean Public Health Agency Member States (Anguilla, Antigua and Barbuda, Aruba, Bahamas, Barbados, Belize, Bermuda, BES Islands, British Virgin Islands, Cayman Islands, Curacao, Dominica, Grenada, Haiti, Guyana, Jamaica, Montserrat, Saint Kitts and Nevis, Saint Lucia, St Maarten, Saint Vincent and the Grenadines, Suriname, Trinidad and Tobago, Turks and Caicos Islands). In some of these countries, there are no regulatory hurdles and we can start offering our tests immediately.

The U.S. Food and Drug Administration (“FDA”) has granted permission for us to export certain of our tests. The FDA’s permission to export was granted under Section 801(e) of the Federal Food, Drug, and Cosmetic Act, as amended (the “FDC Act”). Section 801(e) of the Act covers certain medical devices that have not yet received an approved Premarket Approval in the United States by the FDA, such as our products. Section 801(e) applies to medical devices that are acceptable to the importing country and that are manufactured under the FDA’s Good Manufacturing Practices.

We expect to offer our Zika test in this region first because of the demand for such test followed by tests for tuberculosis, hepatitis B and C, dengue and then our full range of tests.

India

The Company has entered into an agreement to manufacture diagnostics tests for seven infectious diseases with a pharmaceutical manufacturing company in India. The agreement provides for the manufacture of the five tests named above and malaria and HIV and the joint sales and marketing of those tests in India.

Since the tests will be conducted in India on Indian citizens, no FDA approval or inspection will be required. Certain Indian regulatory approval from the Central Drugs Standard Control Organization must be acquired. We are engaging the services of an experienced consultant in India to help us get through this process. Research Use Only reagents are able to be sold without requiring regulatory approval as long as they are labeled and designated as such.

India is the country with the highest burden of tuberculosis. According to the World Health Organization, tuberculosis statistics for India for 2015 give an estimated incidence figure of 2.2 million cases of tuberculosis for India out of a global incidence of 9.6 million. The tuberculosis incidence for India is the number of new cases of active tuberculosis disease in India during a certain time period (usually a year).

Europe

Most molecular tests, such as our tests, are governed in Europe by the European Union’s framework for in vitro diagnostics (“IVDs”), which encompasses diagnostic products such as reagents, instruments and systems intended for use in diagnosis of disease. The regulatory system for IVDs is built largely on a self-certification procedure, placing heavy responsibility on manufacturers. Examples of current obligations include having in place a qualitative manufacturing process, user instructions that are clear and fit for purpose, and ensuring that the ‘physical’ features of devices and diagnostics do not pose any danger. If a product fulfils these and other related control requirements, it may be CE-marked as an indication that the product is compliant with EU legislation and sold in the European Union. In July 2018, we received notification that our test for tuberculosis had received a CE Mark designation and is available for sale in all countries that accept the CE Mark as approval for distribution.

We have received ISO 13485 and ISO 9001 certifications relating to the design and manufacture of certain of our products. The ISO certification indicates that we meet the standards required to self-certify certain of our products and affix a CE marking for sales of our products in countries accepting the CE marking (not in the United States) with only minimal further governmental approvals in each country. We expect to have our Zika, dengue and malaria tests also CE-marked in 2018. We estimate the remaining costs for CE-marks to be approximately $100,000.

United States

We do not anticipate offering our tests in the United States in the near future. We believe, however, our tests may be able to qualify as Laboratory Developed Tests (“LDTs”), diagnostic tests that are developed and manufactured by Clinical Laboratory Improvement Amendments (“CLIA”) certified laboratories. These tests are developed by the lab for use only in that laboratory. CLIA laboratories develop the performance characteristics, perform the analytical validation for their LDTs and obtain licenses to offer them as diagnostic services. The FDA has publicly announced its intention to regulate certain LDTs in a phased-in approach, but draft guidance that was previously published was withdrawn at the end of the Obama administration and replaced by an informal, non-enforceable discussion paper reflecting some of the feedback that it received on LDTs regulation.

Market Opportunity

The molecular diagnostics market is a fast growing portion of the in vitro (test tube based, controlled environment) diagnostics market. There are several advantages of molecular tests over other forms of diagnostic testing, which include higher sensitivities, the ability to perform multiplex tests and the ability to test for drug resistance or individual genes.

Intellectual Property Protection

Because much of our future success and value depends on our proprietary technology, our patent and intellectual property strategy is of critical importance. Three of our initial U.S. patents related to our technology have been granted by the U.S. Patent and Trademark Office (“PTO”). As of June 30, 2018, we had two additional patents pending in the U.S. and foreign counterpart applications. Two of our issued patents expire in 2034 and the other patent expires in 2036.

We have identified additional applications of the technology, which represent potential patents that further define specific applications of the processes that are covered by the original patents. We intend to continue building our intellectual property portfolio as development continues and resources are available.

We have copyrighted our development software that can be used by any lab or developer to develop diagnostic tests based on our technology.

RESULTS OF OPERATIONS

Results of Operations for the Six Months ended June 30, 2018 and 2017

Net Sales

For the six months ended June 30, 2018, we generated $19,392 of net sales compared to net sales of $2,466 in the six months ended June 30, 2017. The revenue in 2018 represented a license fee for licensing our Zika tests and certain other Flaviviruses for limited distribution to a Canadian company. The net sales in 2017 represented rental revenue for the lease of our portable lab.

Cost of Sales

For the six months ended June 30, 2018, we recorded no cost of sales. For the six months ended June 30, 2017, we recorded cost of sales of $302 related to the portable lab leased to a customer.

Operating Expenses

We incurred total operating expenses of $2,650,189 for the six months ended June 30, 2018 compared to total operating expenses of $1,267,481 for the six months ended June 30, 2017. The increase of $1,382,708 was due primarily to increased business activities following the completion of our initial public offering. There was an increase in general and administrative expenses of $1,123,456, an increase of $205,736 in our research and development expenses and an increase in sales and marketing expenses of $49,310. Depreciation and amortization expense also increased $4,206 as a result of the purchase of additional equipment.

General and administrative expenses increased $1,123,456 from $607,258 for the six months ended June 30, 2017 to $1,730,714 for the six months ended June 30, 2018. The increase was primarily the result of an increase of $502,769 in independent consulting expenses and an increase of $312,907 in salaries and related benefits, $203,573 in legal and other professional services and $24,280 in regulatory expenses, all of which were incident to factors relating to becoming a publicly traded company and engaging professionals with market related experience. We also experienced an increase of $82,500 in directors’ fees. Our office rent increased $14,760 incident to moving into our current offices.

Our sales and marketing expenses for the six months ended June 30, 2018 were $239,153 compared to sales and marketing expenses of $189,843 for the six months ended June 30, 2017. The increase of $49,310 is due primarily to an increase of $35,431 in salary and related benefits expense, an increase of $9,797 in office rent, an increase of $8,145 in postage and delivery and an increase of $4,623 in travel expenses, all of which was partially offset by a decrease of $10,106 in advertising and promotion expenses.

Our research and development expenses increased by $205,735 from $449,568 for the six months ended June 20, 2017 to $655,304 for the six months ended June 30, 2018. The increase was primarily due to an increase of $110,676 in payroll and employee related expenses, an increase of $88,061 in consulting and other professional services, an increase of $70,126 in lab supplies, and an increase in building rent and equipment lease expense of $31,388. These increases were partially offset by a decrease in technology royalties expense of $107,500

Interest Expense

For the six months ended June 30, 2018, we incurred no interest expense compared to interest expense for the six months ended June 30, 2017 of $295,432. The decrease of $295,432 was the result of having all of our indebtedness retired coincident with the funding of our initial public offering. We also realized interest income of $13,841 from the investment of funds not used in the operations of the business.

Net Loss

We realized a net loss for the six months ended June 30, 2018 of $2,682,410 compared with a net loss for the six months ended June 30, 2017 of $1,560,749. The increase in net loss of $1,121,661 was the result of the increased operating expenses explained above and a $65,454 loss on investment related to our Indian joint venture, partially offset by the decrease of $295,432 in interest expense.

Results of Operations for the Three Months ended June 30, 2018 and 2017

Net Sales

For the three months ended June 30, 2018, we generated $9,696 of net sales compared to net sales of $2,466 in the three months ended June 30, 2017. The revenue in 2018 represented a license fee for licensing our Zika tests and certain other Flaviviruses for limited distribution to a Canadian company. The net sales in 2017 represented rental revenue for the lease of our portable lab.

Cost of Sales

For the three months ended June 30, 2018, we recorded no cost of sales and for the three months ended June 30, 2017, we recorded cost of sales of $302 related to the portable lab leased to a customer.

Operating Expenses

We incurred total operating expenses of $1,363,062 for the three months ended June 30, 2018 compared to total operating expenses of $703,116 for the three months ended June 30, 2017. The increase of $659,946 was due primarily to increased business activities following the completion of our initial public offering. There was an increase in general and administrative expenses of $467,144, an increase of $173,009 in our research and development expenses and an increase in sales and marketing expenses of $18,264.

General and administrative expenses increased $467,144 from $381,524 for the three months ended June 30, 2017 to $848,668 for the three months ended June 30, 2018. The increase was primarily the result of an increase of $192,439 in independent consulting expenses and an increase of $131,118 in salaries and related benefits. The increase in general and administrative expenses also resulted from an increase of $116,554 in legal and other professional services, which services were incident to our becoming a publicly traded company and engaging professionals with market related experience. We also experienced an increase of $41,250 in directors’ fees. Our office rent increased $6,847 incident to moving into our current offices.

Our sales and marketing expenses for the three months ended June 30, 2018 were $143,890 compared to sales and marketing expenses of $125,626 for the three months ended June 30, 2017. The increase of $18,264 is due primarily to an increase of $9,333 in salary and related benefits expense, an increase of $6,464 in office rent and an increase of $6,332 in travel expenses, partially offset by a decrease of $10,799 in advertising and promotion expenses.

Our research and development expenses increased by $173,008 from $184,880 for the three months ended June 30, 2017 to $357,889 for the three months ended June 30, 2018. The increase was primarily due to an increase of $84,214 in lab supplies, an increase of $51,828 in payroll and employee related expenses, an increase of $20,290 in other professional services and an increase in building rent and equipment lease expense of $13,439.

Interest Expense

For the three months ended June 30, 2018, we incurred no interest expense compared to interest expense for the three months ended June 30, 2017 of $154,055. The decrease of $154,055 was the result of having all of our indebtedness retired coincident with the funding of our initial public offering. We also realized interest income of $6,280 from the investment of funds not used in the operations of the business.

Net Loss

We realized a net loss for the three months ended June 30, 2018 of $1,372,177 compared with a net loss for the three months ended June 30, 2017 of $855,007. The increase in net loss resulted from an increase of $659,946 in operating expenses explained above and a $25,091 loss on investment related to our Indian joint venture, partially offset by the decrease of $154,055 in interest expense.

Liquidity and Capital Resources

Liquidity is the ability of a company to generate funds to support its current and future operations, satisfy its obligations, and otherwise operate on an ongoing basis. Significant factors in the management of liquidity are funds generated by operations, levels of accounts receivable and accounts payable and capital expenditures.

To date, we have financed our operations primarily through sales of common stock and the issuance of convertible debt.

At June 30, 2018, we had cash and cash equivalents of $1,528,267, total current assets of $1,779,774, total current liabilities of $290,567 and total stockholders’ equity of $1,243,114. At December 31, 2017, we had cash and cash equivalents of $3,534,454, total current assets of $4,451,874, total current liabilities of $268,256 and total stockholders’ equity of $3,850,524.

We experienced negative cash flow from operations during the six months ended June 30, 2018 of $1,936,498 compared to negative cash flow from operations for the six months ended June 30, 2017 of $667,302. The negative cash flow was met by cash reserves remaining from the issuance of common stock incident to the completion of our initial public offering. The amount of our operating deficit could decrease or increase significantly depending on strategic and other operating decisions, thereby affecting our need for additional capital. Our liquidity and operating results will also depend on the amount of revenue generated. We expect our operating losses will continue until we are able to generate significant levels of revenue. Although licensing fees have enabled us to begin generating revenue in 2018, such revenue has been minimal through June 30, 2018.

Until our revenues become substantial and our operations become profitable, we will continue to rely on proceeds received from our initial public offering and other sources of capital. We expect additional investment capital to come from (i) additional private placements of our common stock with existing and new investors and (ii) the private placement of other securities with investors similar to those that have provided funding in the past.

Our monthly cash operating expenses, including our technology research and development expenses, were approximately $324,365 per month during the six months ended June 30, 2018. Our operating expenses increased significantly upon completion of our initial public offering as we increased development and sales activities in furtherance of our business plan.

Our long-term liquidity is dependent upon execution of our business model and the realization of substantial revenue generating activities and working capital as described above, and upon capital needed for continued commercialization and development of our diagnostic testing technology. Commercialization and future development of diagnostic tests utilizing our PCR technology are expected to require additional capital estimated to be approximately $1,000,000 annually for the foreseeable future. This estimate will increase or decrease depending on specific opportunities and available funding.

The foregoing estimates, expectations and forward-looking statements are subject to change as we make strategic operating decisions from time to time and as our expenses and net sales fluctuate from period to period.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements.