Avinger(US:AVGR)2020-05-13 20:31Financial Performance - The company generated revenues of $9.1 million in 2019, with growth attributed to the next-generation Pantheris and the launch of Pantheris SV[113]. - For the three months ended March 31, 2020, revenue increased by $0.4 million or 23% compared to the same period in 2019, reflecting the impact of an increased sales force and the release of the Pantheris SV product[146]. - Gross profit for the three months ended March 31, 2020, was $501,000, resulting in a gross margin of 22%, compared to a gross profit of $373,000 and a gross margin of 20% for the same period in 2019[145]. - Gross margin for the three months ended March 31, 2020 increased to 22%, compared to 20% in the same period of 2019, primarily due to economies of scale from increased production[148]. - The net loss for the three months ended March 31, 2020, was $5.851 million, compared to a net loss of $5.055 million for the same period in 2019[145]. Expenses - Total operating expenses for the three months ended March 31, 2020, were $5.98 million, an increase from $5.4 million in the same period in 2019[145]. - Research and development expenses for the three months ended March 31, 2020, were $1.594 million, compared to $1.414 million for the same period in 2019[145]. - Selling, general and administrative expenses for the three months ended March 31, 2020, were $4.386 million, an increase from $3.986 million in the same period in 2019[145]. - Research and Development (R&D) expenses for the three months ended March 31, 2020 increased by $0.2 million or 13% compared to the same period in 2019, driven by higher project spending for next-generation products[149]. - Selling, General and Administrative (SG&A) expenses for the three months ended March 31, 2020 increased by $0.4 million or 10% compared to the same period in 2019, mainly due to increased personnel-related expenses[150]. - Interest expense, net for the three months ended March 31, 2020 increased by 37% or $0.1 million compared to the same period in 2019, primarily due to a higher loan balance and lower interest income[151]. Cash Flow and Financing - Cash and cash equivalents as of March 31, 2020 were $9.9 million, down from $10.9 million as of December 31, 2019, with an accumulated deficit of $354.2 million[153]. - Net cash used in operating activities for the three months ended March 31, 2020 was $5.0 million, consisting primarily of a net loss of $5.9 million[165]. - Net cash provided by financing activities for the three months ended March 31, 2020 was $3.9 million, primarily from the issuance of common stock in a public offering[168]. - The company received net proceeds of approximately $3.1 million from a public offering of 12.6 million shares of common stock at an offering price of $0.25 per share on April 30, 2020[134]. - 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[117]. - The company received loan proceeds of $2.3 million under the Paycheck Protection Program, which may be forgiven if used for qualifying expenses[160]. - The total contractual obligation under the CRG Loan as of March 31, 2020 is $14.2 million, which includes future interest and a back-end fee[170]. Compliance and Regulatory - The company received a letter from Nasdaq regarding non-compliance with listing rules due to its stock price being below $1 for 30 consecutive business days[118]. - The company anticipates filing a 510(k) submission for Ocelaris, a next-generation image-guided CTO-crossing device, in Q2 2020, with a product launch expected by Q4 2020[111]. - The company plans to submit a 510(k) application for the L300 imaging console in the second half of 2020, expected to enhance imaging capabilities[111]. Operational Impact of COVID-19 - The company has experienced delays in clinical studies due to COVID-19, which may adversely affect its business and results of operations[114]. - The company has reduced base salaries for non-manufacturing employees by 20% and adjusted manufacturing hours in response to COVID-19[115]. Business Operations - The company has been commercializing its Lumivascular platform products since late 2012, with Pantheris being a key product launched in March 2016[113]. - The company has a minimum revenue covenant of $15 million for 2020, increasing to $25 million for 2022, as per the amended loan agreement with CRG[123]. - The business primarily operates in U.S. dollars, minimizing the impact of foreign currency transactions on financial results[174]. - A 10% adverse change in Euro exchange rates versus the U.S. dollar is estimated to have no material effect on the fair value of monetary assets[174].