Avinger(US:AVGR)2020-11-10 22:26Financial Performance - The company generated revenues of $9.1 million in 2019, an increase from $7.9 million in 2018, primarily due to the launch of the next-generation Pantheris and Pantheris SV products [124]. - As of September 30, 2020, the company reported a net loss of $4.5 million for the third quarter and a comprehensive net loss of $14.4 million for the nine months, with an accumulated deficit of $362.7 million [135]. - For the three months ended September 30, 2020, revenues were $2.302 million, a decrease of 4.5% compared to $2.410 million for the same period in 2019 [158]. - The net loss for the three months ended September 30, 2020, was $4.525 million, compared to a net loss of $4.623 million for the same period in 2019 [158]. - For the nine months ended September 30, 2020, revenue decreased by $0.5 million or 8% compared to the same period in 2019, reflecting the impact of COVID-19 on elective procedures [167]. Sales and Market Impact - The company experienced a significant decline in sales during the second quarter of 2020 due to COVID-19, but saw a rebound in sales in the third quarter as elective procedures resumed [125]. - The company is focused on interventional cardiologists, vascular surgeons, and interventional radiologists for its marketing efforts, considering hospitals as key customers [123]. Product Development and Regulatory Approvals - The company received 510(k) clearance for the Pantheris SV in April 2019, targeting smaller vessels, and commenced sales in July 2019 [116]. - The company received 510(k) clearance for the Ocelaris ("Tigereye") system in September 2020, which features high-definition imaging and a user-controlled deflectable tip [117]. - The company is developing the next generation of the Lightbox imaging console, the L300, with enhanced imaging capabilities and plans to file a 510(k) submission in the first quarter of 2021 [122]. Expenses and Cost Management - Total operating expenses for the three months ended September 30, 2020, were $4.878 million, down from $5.462 million in the same period of 2019 [158]. - Research and development expenses for the three months ended September 30, 2020, were $1.417 million, an increase from $1.371 million in the same period of 2019 [158]. - Selling, general and administrative expenses for the three months ended September 30, 2020, were $3.461 million, down from $4.091 million in the same period of 2019 [158]. - SG&A expense for the three months ended September 30, 2020 decreased by approximately $0.6 million or 15% compared to the same period in 2019, mainly due to reduced compensation costs and lower third-party expenses [164]. Financing and Cash Flow - The company received a loan of $2.3 million under the Paycheck Protection Program on April 23, 2020, to help mitigate the effects of COVID-19 [129]. - The company completed a public offering of 12.6 million shares of common stock at an offering price of $0.25 per share on April 30, 2020, resulting in net proceeds of approximately $3.0 million [145]. - Net cash used in operating activities for the nine months ended September 30, 2020 was $11.7 million, consisting primarily of a net loss of $14.4 million and an increase in net operating assets of approximately $0.8 million [191]. - Net cash provided by financing activities for the nine months ended September 30, 2020 was $26.0 million, primarily from the issuance of common stock and $2.3 million from borrowings under the PPP [194]. Future Outlook - The company expects gross margin to increase over the long term as production volume increases and fixed manufacturing overhead costs are spread over a larger number of units produced [153]. - The company expects to incur losses for the foreseeable future and believes its current cash and expected revenues will be sufficient to fund operations through at least the fourth quarter of 2021 [174]. Compliance and Risk Management - The company is actively monitoring compliance with Nasdaq Listing Rules, having received a notice regarding non-compliance due to the stock price being below $1 [131]. - An immediate 100 basis point change in interest rates would not have a material effect on the fair value of the company's cash equivalents [200]. - The company maintains cash and cash equivalents with one financial institution, which is believed to have sufficient assets and liquidity, posing little credit risk [201].