Technology and Innovation - Co-Diagnostics, Inc. has developed proprietary molecular diagnostics technology that allows for rapid, low-cost testing for infectious diseases and genetic conditions[20]. - Co-Diagnostics' proprietary Co-Primer technology enhances specificity in testing, allowing for multiplexing several targets and improved SNP detection[23][49]. - The company has developed a novel PCR test design technology called "Co-Primers," which aims to reduce false positives and negatives in DNA identification[78]. - Co-Diagnostics has established a licensing agreement in the agricultural sector for its Co-Primer technology, which will generate royalties from sales to the licensee's customers[52]. Market Demand and Growth - The company estimates a global annual demand for its initial diagnostic tests could reach approximately 1.99 billion tests, with specific demands including 10.4 million for tuberculosis and 36.7 million for HIV[40]. - The molecular diagnostics market is identified as a fast-growing segment, with Co-Diagnostics positioned to capitalize on this growth through its innovative testing solutions[40]. - The company is classified as an "emerging growth company" and will maintain this status until total annual gross revenues exceed $1 billion or other specified conditions are met[56]. Regulatory and Certifications - Co-Diagnostics has received CE Marks for its tuberculosis test, Zika test, and a triplex test for Zika, Dengue, and Chikungunya, allowing sales throughout the European community and in most Central and South American countries[27][38]. - The company has received ISO 13485 and ISO 9001 certifications, enabling it to self-certify certain products for CE marking in Europe[38]. - The company is regulated by the U.S. FDA and has obtained CE Marks for its tuberculosis and zika virus tests, allowing sales in various international markets[94]. Financial Performance - Net sales for the year ended December 31, 2018, were $700, with diagnostic equipment sales of $10,123 and licensing revenue of $29,088, compared to no test revenue in 2017[98]. - Net sales for the year ended December 31, 2018, were $39.91 million, a significant increase from $7.66 million in 2017, representing a growth of approximately 420%[133]. - Gross profit for 2018 was $30.52 million, compared to $7.36 million in 2017, indicating a substantial increase in profitability[133]. - The net loss for the year ended December 31, 2018, was $6,271,723, a decrease of $687,509 compared to a net loss of $6,959,232 in 2017, mainly due to the absence of a loss on extinguishment of debt recorded in 2017[105]. - Total operating expenses increased to $6,148,336 in 2018 from $4,571,427 in 2017, an increase of $1,576,909, primarily due to higher general and administrative, sales and marketing, and research and development expenses[101]. Cash Flow and Expenses - Cash and cash equivalents decreased to $950,237 as of December 31, 2018, from $3,534,454 in 2017, with total current liabilities increasing significantly to $2,351,983[107]. - Monthly cash operating expenses were approximately $385,000 during the year ended December 31, 2018, reflecting increased development and sales activities following the initial public offering[112]. - Negative cash flow used in operations was $4,080,036 for the year ended December 31, 2018, compared to $3,211,401 in 2017[111]. - The company expects to require approximately $850,000 annually for the continued commercialization and development of its diagnostic testing technology[116]. Joint Ventures and Collaborations - The company has entered a joint venture with Synbiotics Limited to manufacture diagnostics tests for seven infectious diseases, with profits shared based on performance levels[85]. - The joint venture has already sold approximately $200,000 worth of probes and primers in India, marking the beginning of product sales in that market[85]. - The company invested $339,000 in a joint venture in India in 2018, up from $60,000 in 2017, marking a significant increase of 465%[140]. Stock and Equity - As of March 15, 2019, the last reported sales price of the company's common stock was $1.15 per share, with approximately 429 holders of the stock[69]. - The company executed an 11 to 1 reverse stock split on May 24, 2017, affecting the statements in this report[144]. - The company completed a registered direct offering in February 2019, raising net proceeds of $4,996,322 from the sale of 3,925,716 shares of common stock[114]. - The company completed a registered direct offering in February 2019, selling 3,925,716 shares of common stock at a price of $1.40 per share, raising gross proceeds of $5,496,002[214]. Employee and Compensation - The company currently employs 20 full-time personnel and engages independent contractors in India for product promotion[93]. - The company recognized $468,240 in stock-based compensation for the 850,000 options granted to nine employees for the year ended December 31, 2018[186]. - For the year ended December 31, 2018, the company granted 850,000 options with a weighted average fair value of $1.24, while the options granted in 2017 were 61,335 with a fair value of $1.59[185]. Liabilities and Obligations - Cash and cash equivalents at the end of the period decreased to $950,237 in 2018 from $3,534,454 in 2017, a decline of approximately 73%[1]. - Total current liabilities increased significantly to $2.35 million in 2018, compared to $628,256 in 2017, representing a rise of approximately 273%[130]. - The company reported an accumulated deficit of $18.69 million as of December 31, 2018, compared to $12.42 million in 2017, reflecting an increase in losses[130]. - The company recorded a total of $1,908,572 in notes payable as of December 31, 2018, with a principal amount of $2,000,000 issued to Robert Salna bearing an interest rate of 9%[179]. - The company incurred $71,000 in interest expense related to the notes payable for the 12 months ended December 31, 2018[181].