Astrotech (US:ASTC)2020-09-08 19:50Product Development and Innovation - The TRACER 1000, developed by 1st Detect, is the world's first mass spectrometer-based explosives trace detector certified by ECAC, designed to replace existing ETDs at airports and cargo facilities[10]. - The AgLAB-1000 series, developed by AgLAB Inc., is focused on detecting trace levels of solvents and pesticides in the agriculture industry, particularly in the hemp and cannabis markets[12]. - The Company launched the BreathTest-1000, a breath analysis tool aimed at screening for VOC metabolites that could indicate infections like COVID-19, with results expected in approximately 60 seconds[18]. - The AgLAB-1000-D2 has been launched to assist in the oil extraction and distillation process, maximizing product quality and yield for the hemp and cannabis industry[15]. - The BreathTest-1000 is designed to screen for VOC metabolites in breath, indicating potential infections like COVID-19, targeting high-density areas such as hospitals and schools[21]. - The BreathTest-1000 employs core AMS Technology, with ongoing R&D focused on sample introduction and library development for lung infection detection[24]. - The AgLAB-1000 series continues to develop its libraries for cannabinoids, terpenes, solvents, and pesticides, with plans for product line expansion in the hemp and cannabis industry[23]. - Significant resources are allocated to R&D for cross-platform AMS Technology, focusing on product derivatives and system improvements[22]. Financial Performance - Total revenue for the year ended June 30, 2020, was $488 million, a significant increase from $127 million in 2019, representing a growth of 284%[121]. - Gross profit for the same period was $39 million, compared to $37 million in 2019, indicating a slight increase[121]. - The net loss for the year was $8,311 million, compared to a net loss of $7,534 million in 2019, reflecting a deterioration in financial performance[121]. - The accumulated deficit increased to $199,779,000 in 2020 from $191,698,000 in 2019, indicating ongoing financial challenges[119]. - The company reported total stockholders' equity of $625,000 as of June 30, 2020, down from $2,708,000 in 2019[119]. - The total liabilities and stockholders' equity amounted to $5,930,000 as of June 30, 2020, compared to $3,692,000 in 2019[119]. - The company has suffered recurring losses from operations, raising substantial doubt about its ability to continue as a going concern[116]. Regulatory Compliance - The FDA classification for the BreathTest-1000 is pending, which will determine the necessary premarket submission process[24]. - The company is exploring the Emergency Use Authorization (EUA) to expedite the market entry of the BreathTest-1000, which could take one to several months for authorization[25]. - Class III medical devices require submission through the Premarket Approval (PMA) process, which is more demanding than the 510(k) process, and can take up to several years for FDA review[31]. - The FDA has 180 days to complete its review of a PMA application, although actual review times often exceed this period[31]. - The FDA may approve a PMA application with post-approval conditions, including restrictions on labeling and requirements for long-term follow-up data from clinical studies[31]. - Medical device manufacturers must undergo a conformity assessment procedure to demonstrate compliance with essential requirements in the European Economic Area (EEA)[38]. - The Medical Devices Regulation (Regulation 2017/745) will become applicable in May 2021, establishing a uniform regulatory framework across the EEA[39]. - Non-compliance with medical device regulations may result in enforcement actions, including recalls and revocation of certificates of conformity[39]. - The FDA has broad regulatory compliance and enforcement powers, which can include fines, recalls, and criminal prosecution for violations[36]. Corporate Governance and Management - The board of directors includes experienced members such as Thomas B. Pickens III, who has served since 2004, and Ronald W. Cantwell, who has extensive experience in corporate investment structuring[188][195]. - The Company’s Code of Ethics and Business Conduct applies to all directors, officers, and employees, ensuring legal and ethical conduct[211]. - The Audit Committee met four times during fiscal year 2020, ensuring compliance with Nasdaq and SEC rules[205]. - The Compensation Committee met once during fiscal year 2020 to determine executive compensation[209]. - The Corporate Governance and Nominating Committee did not meet during fiscal year 2020[210]. - Management's report on internal controls was not subject to attestation by the registered public accounting firm, as permitted under the Dodd-Frank Act[186]. - Mr. Wilkinson has significant financial experience and is recognized as an "audit committee financial expert" by the SEC[198]. - Eric N. Stober has been with Astrotech Corporation since 2008 and became CFO in 2013, bringing extensive experience in private equity and finance[199]. - Rajesh Mellacheruvu has served as Vice President and COO since February 2015 and is also the CEO of 1st Detect[200]. Market and Sales Strategy - The Company is currently focused on developing partnerships with distributors in the hemp and cannabis market to enhance sales of the AgLAB product line[18]. - The TRACER 1000 has been delivered to eight countries across Europe and Asia, indicating successful international market penetration[8]. - The Company has received ECAC certification for the TRACER 1000, allowing it to market to airports and cargo facilities outside the U.S.[10]. - The company is working with TSA for certification in the U.S., with the TRACER 1000 accepted into TSA's Air Cargo Screening Technology Qualification Test[128]. - For the fiscal year ended June 30, 2020, one customer accounted for 100% of the company's revenue, highlighting a significant concentration risk[168]. Liquidity and Capital Resources - The Company raised approximately $1.6 million from the sale of 354,000 shares at $5.00 per share and $2.9 million from 873,335 shares at $3.75 per share in March 2020[8]. - The company is evaluating several potential sources for additional liquidity, including selling the company or a portion thereof, licensing technology, and raising funds through capital markets[151]. - The company entered into a private placement transaction for a secured promissory note with a principal amount of $1.5 million on September 5, 2019, and an additional $1.0 million on February 13, 2020[151]. - The company has a total of $1.5 million in secured promissory notes with an interest rate of 11% per annum, due on September 5, 2021[162]. - The company reported net cash used in operating activities of $6.9 million for the fiscal year 2020, compared to $8.5 million for the fiscal year 2019[150]. Employee and Compensation Matters - As of June 30, 2020, the company employed 27 employees, none of whom were covered by collective bargaining agreements[45]. - The company has 325,313 stock options outstanding with a weighted average exercise price of $5.68 as of June 30, 2020[171]. - Compensation costs recognized related to vested stock option awards were $147,000 for the year ended June 30, 2020[171]. - The company recognized compensation costs related to vested restricted stock awards of $202 thousand for the year ended June 30, 2020, compared to $135 thousand for the previous year[173]. - The company has $13,000 of total unrecognized compensation cost related to non-vested stock option awards, expected to be recognized over a weighted average period of 2.3 years[171].